WO2012032494A1 - Composition comprising a fig plant material extract and use thereof in the treatment of benign prostatic hyperplasia - Google Patents

Composition comprising a fig plant material extract and use thereof in the treatment of benign prostatic hyperplasia Download PDF

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Publication number
WO2012032494A1
WO2012032494A1 PCT/IB2011/053951 IB2011053951W WO2012032494A1 WO 2012032494 A1 WO2012032494 A1 WO 2012032494A1 IB 2011053951 W IB2011053951 W IB 2011053951W WO 2012032494 A1 WO2012032494 A1 WO 2012032494A1
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ficus
composition
extract
miq
leaved
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PCT/IB2011/053951
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French (fr)
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Behrooz Kasraee
Mohamed Amine Korchi
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Behrooz Kasraee
Mohamed Amine Korchi
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Publication of WO2012032494A1 publication Critical patent/WO2012032494A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate

Definitions

  • the present invention relates to a composition
  • a composition comprising an extract of fig plant material, preferably extract of fig leaves, and the use thereof in a method of preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
  • Prostatic Hyperplasia (BPH, also called benign prostatic hypertrophy) is characterized by hyperplasia of prostatic stromal and epithelial cells, resulting in the formation of large, fairly discrete nodules, in the periurethral region of the prostate. When sufficiently large, the nodules compress the urethral canal to cause partial or sometimes complete obstruction of the urethra which interferes the normal flow of urine.
  • the symptoms of BPH vary, but the most common ones involve changes in, or problems with, urination, such as urinary hesitancy, dysuria (painful urination), urinary interruption, weak stream, urgency and leaking or dribbling as well as more frequent urination especially at night.
  • the size of the prostate does not always determine how severe the obstruction or the symptoms will be. Some men with greatly enlarged glands have little obstruction and few symptoms while others, whose glands are less enlarged, have more blockage and greater problems. Sometimes a man may not know he has any obstruction until he suddenly finds himself unable to urinate at all. This condition, called acute urinary retention, may be triggered by taking over-the-counter cold or allergy medicines. Such medicines contain a decongestant drug, known as a sympatho-mimetic. A potential side effect of this drug may prevent the bladder opening from relaxing and allowing urine to empty. When partial obstruction is present, urinary retention also can be brought on by alcohol, cold temperatures, or a long period of immobility. BPH can already begin at the age of 30 years.
  • BPH histologic evidence of BPH by age 50 years and 75% by age of 80 years. If BPH is not symptomatic it is usually not treated and the patient is just regularly followed by the physician. When symptoms of BPH begin to appear medical treatments are used. These include the administration of alpha- 1 blockers (for example Tamsulosine, Alfuzosine and Terazosine), 5-alpha reductase inhibitors (Finasteride and Dutasteride) and sometimes anticholinergics.
  • alpha- 1 blockers for example Tamsulosine, Alfuzosine and Terazosine
  • 5-alpha reductase inhibitors Feinasteride and Dutasteride
  • anticholinergics sometimes anticholinergics.
  • the present invention provides a composition comprising an extract of fig leaves. Further the present invention provides the composition of the invention for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
  • the present invention provides a composition for preventing and/or treating benign prostatic hyperplasia comprising an extract of fig leaves.
  • treatment used herein to generally refer to obtaining a desired pharmacologic and/or physiologic effect in a mammal, particularly in a human male.
  • the effect may be prophylactic in terms of completely or partially preventing a disease or symptom of Benign Prostatic Hyperplasia from occurring in a subject which may be predisposed to the disease or symptom but has not yet been diagnosed as having it and/or (b) may be therapeutic in terms of a partial or complete stabilization, cure or inhibition of Benign Prostatic Hyperplasia symptom i. e., arresting its development; and/or relieving Benign Prostatic Hyperplasia symptom, i. e., causing regression of the disease or symptom.
  • the extract of fig leaves of the present invention is used to prevent and/or treat Benign Prostatic Hyperplasia (BPH, also called benign prostatic hypertrophy) and/or symptoms of benign prostatic hyperplasia.
  • Said treatment also includes alleviation of the symptoms commonly associated with Benign Prostatic Hyperplasia, wherein the alleviation of symptoms may or not be associated with a decrease in the size of a hypertrophied prostate gland.
  • Benign prostatic hyperplasia symptoms are usually classified as storage or voiding.
  • Storage symptoms include urinary frequency, urgency (compelling need to void that cannot be deferred), urgency incontinence, and voiding at night (nocturia).
  • Voiding symptoms include urinary stream, hesitancy (needing to wait for the stream to begin), intermittency (when the stream starts and stops intermittently), weak urine flow, straining to void, and dribbling. Pain and dysuria may be also included in benign prostatic hyperplasia symptoms.
  • Fig trees (Family: Moraceae, Tribe: Ficeae, Genus: Ficus) including the common fig ⁇ Ficus carica), are large deciduous shrubs or small trees native to southwest Asia and the
  • fig Ficus Afghanistanica known as the wild mountain fig, is native to Afghanistan, Iran and Pakistan but can also be found in Bavaria in Germany.
  • the leaves of fig trees are 12-25 cm long and 10-18 cm across, and are deeply lobed, with 3 to 5 lobes.
  • the fruit, known as a fig is a good source of potassium, a mineral that helps to control blood pressure.
  • Figs are also one of the highest sources of dietary fibre and are shown to reduce the incidence of breast cancer in a study involving 51,823 postmenopausal women (International Journal of Cancer, 2008. Jan. 15; 122(2):403-12).
  • CN101104013 has shown that extracts of fig leaves have anti-diabetic properties, reducing the amount of insulin needed by diabetics.
  • fig leaves and extracts of same include Bronchitis, cardiovascular problems, cancer, genital warts, haemorrhoids, liver cirrhosis, lowering blood pressure, ringworm, scalp fungal infections, shingles and ulcers.
  • extract means a composition prepared by method comprising contacting an extraction medium with fig plant material under conditions suitable for drawing one or more chemical compounds from the fig plant material into the extraction medium, thereby forming an extraction solution.
  • the extraction solution may then be separated from the fig plant material, and may optionally be diluted or reduced or dried, to form the extract, for example liquid extract or solid (such as powder) extract.
  • An extract may be purified or substantially purified.
  • the extraction medium is aqueous medium. Most preferably the extraction medium is water.
  • substantially purified means substantially free of contaminants which are associated with the fig plant material in its native environment. Purification may be
  • Plant material means any part or parts of at least one plant from the Ficus species, preferably Ficus Afghanistanica.
  • Fig plant material may include the whole plant or any part or parts of the plant, such as the bark, root, stem, leaves, flowers, fruit, seeds, branches, stalks and/or parts or mixtures thereof.
  • the fig plant material are leaves.
  • Fig plant material may be fresh cut, dried (including freeze dried), frozen and the like.
  • Fig plant material may also be whole or separated into small parts.
  • a biologically active extract contained in a composition of the present invention may be made using various portions of the fig plant, such as bark, roots, stems, leaves and combinations thereof.
  • a biologically active extract contained in a composition of the present invention is made by using leaves.
  • the present invention provides a composition
  • a composition comprising an extract of fig plant material, preferably an extract of fig leaves.
  • said fig plant material, more preferably said fig leaves are obtained from Ficus species selected from the group comprising
  • Ficus apollinaris Dugand F. petenensis Lundell
  • Ficus benghalensis Indian Banyan, Bengal Fig, East Indian Fig, borh (Pakistan), vad/vat/wad, nyagrodha, "indian fig"
  • Ficus carchiana C. C.Berg Ficus carica— Common Fig, anjeer (Iran, Pakistan), dumur (Bengali) Ficus castellviana
  • Ficus dammaropsis Highland Breadfruit, kapiak (Tok Pisin)
  • Ficus elastica Indian Rubber Plant, Rubber Fig, "rubber tree”, “rubber plant” Ficus elastica cv. 'Decora '
  • Ficus microcarpa Chinese Banyan, Malayan Banyan, Curtain Fig, "Indian laurel” Ficus microcarpa var. hillii— Hill's Fig
  • Ficus microcarpa var. nitida often considered a subspecies of F. retusa or a distinct species
  • Ficus racemosa Cluster Fig, Goolar Fig, udumbara (Sanskrit), umbar (India) Ficus ramiflora
  • Ficus virens White Fig, pilkhan, an-borndi (Gun-djeihmi) Ficus virens var. sublanceolata White Fig, New South Wales
  • Ficus watkinsiana Watkins' Fig, Nipple Fig, Green-leaved Moreton Bay Fig
  • fig leaves are obtained from Ficus afghanistanica.
  • the extract of fig plant material preferably the extract of fig leaves, can be a liquid extract or a solid extract (such as powder).
  • a liquid extract is an aqueous liquid extract.
  • composition of the invention can be in the form of liquid tea, beverage, tincture, ampoule, gel and/or syrup as well as in the form of dry tea, capsule, pill and/or tablet.
  • composition of the present invention can contain only the extract of fig plant material, preferably extract of fig leaves.
  • fig leaves can be dried using a number of procedures which include, but not limited to, air drying, oven drying, or microwave drying.
  • Air drying Simply tying the fig leaves in bunches and hanging them upside-down in a dark and dry place, at about 20 - 25 °C. Depending on what kind fig leaves, it can take a few days and up to weeks for them to dry completely.
  • Oven drying The fig leaves are put on a sheet in a thin layer and are placed in a low setting oven.
  • Microwave drying The fig leaves are put on a plate and the microwave is set on low. Depending to the microwave, this may take from 2 to 5 minutes.
  • fig leaves Once the fig leaves are dried, they can be crushed to make a tea-like composition and placed in « fig leaf » tea bags.
  • a fig leaf tea bag should be immersed in hot, but preferably not boiling water for a few minutes, prior to consumption of the fig leaf tea.
  • composition of the invention is a beverage, which is a
  • substantially aqueous drinkable composition suitable for human consumption.
  • the beverage will typically comprise at least 70% water, more preferably at least 80%, optimally between 85 and 99% by weight of the beverage.
  • the total amount of extract of fig plant material, preferably extract of fig leaves typically be from 0.001 to 5%, more preferably from 0.01 to 3% and most preferably from 0.1 to 1% by weight of the beverage.
  • the beverage may contain other optional components such as a chelator, colorant, preservative (e.g., potassium sorbate, sodium benzoate or a mixture thereof), flavour, vitamin, sweetener (e.g, corn syrup, sucrose or a mixture thereof), fruit juice, surfactant (e.g, sorbitan monolaurate, sorbitan monopalmitate or a mixture thereof), acidulant, non-fat milk solids, fat (e.g. milk fat, vegetable fat or a mixture thereof) or mixtures thereof.
  • a chelator e.g., colorant, preservative
  • the composition of the present invention is a tea.
  • a tea To extract fig leaves into a tea, usually a few fresh leaves or dried leaves are used.
  • a fig leaf tea bag is used.
  • the leaves can be macerated briefly in a mortar and pestle or crushed in a bowl. Then the leaves are placed for example into a teacup and boiling or hot water is poured over the leaves.
  • the tea is allowed to steep for 10 minutes, preferably 5 to 7 minutes, and then it is strained (for example filtered) and finally it is ready to drink.
  • a larger amount of tea can be made and the leftovers can be stored for example in refrigerator for up to five days, preferably two days.
  • tea can contain an amount of fresh or dried fig leaves/water from about 0.001% to about 99% by weight, preferably from about 0.01% to about 80% by weight.
  • the composition of the present invention can be a tincture, which is also made from fig leaves and which can be used either fresh or dried.
  • Tinctures can be made from liquids such as vodka, rum, brandy, vinegar or vegetable glycerine, but alcohol yields the strongest concentration of the fig's ingredients. Only a small amount is taken, so the alcohol will have no noticeable effect on the consciousness of a subject. It's convenient to make at least 500 ml of tincture because the brewing process can take one month. A 500 ml glass jar is filled one-third full with rinsed, chopped fig leaves, and then it is filled with a liquid such as vodka, rum, brandy, vinegar or vegetable glycerine.
  • An extract of fig leaves can be also an aqueous extraction of fig leaves which is filtered, concentrated, and optionally extracted with further organic solvents. The extract can be further air-dried under vacuum, optionally dissolved in ethanol, and filtered. The final extract of fig leaves is obtained after ethanol was evaporated under vacuum.
  • An extract of fig leaves can be further an organic extract.
  • fig leaves are preferably ground into a fine powder, the resultant powder is extracted with a solvent, and the extraction solvent is removed from the extract.
  • the whole fig plant or parts other than leaves may be used.
  • the resultant extract may be further purified to yield a purified extract or one or more purified compositions.
  • the grinding step may be accomplished by any commonly known method for grinding a plant substance. For example, the plant or parts thereof may be passed through a grinder to obtain a fine powder. After the plant or parts thereof have been ground into a fine powder, they are combined with an extraction solvent. The solution is then stirred at a temperature, and for a period of time, that is effective to obtain an extract with the desired activity.
  • the solution is preferably not overheated, as this may result in degradation and/or denaturation of compounds in the extract.
  • the solution may be stirred at a temperature between about room temperature (25° C) and the boiling point of the extraction solvent. Preferably, the solution is stirred at about room temperature.
  • the length of time during which the plant powder is exposed to the extraction solvent is not critical. Up to a point, the longer the plant powder is exposed to the extraction solvent, the greater is the amount of extract that may be recovered.
  • the solution is stirred for at least 1 minute, more preferably for at least 15 minutes, and most preferably for at least 60 minutes.
  • the extraction process of the present invention is desirably carried out using an organic solvent or a mixture of organic solvents.
  • Organic solvents which may be used in the extraction process of the present invention, include but are not limited to hydrocarbon solvents, ether solvents, chlorinated solvents, acetone, ethyl acetate, butanol, ethanol, methanol, isopropyl alcohol and mixtures thereof.
  • the fig plant material preferably fig leaves can be converted into other formulations than tea.
  • Formulations such as pills, capsules, syrups, ampoules, gels, and other forms suitable for administration, containing the fig plant material extract, preferably fig plant leaves extract, can be employed.
  • Those of ordinary skill in the art of preparing pharmaceutical formulations can readily formulate pharmaceutical compositions having fig plant extracts using known excipients (e. g., saline, glucose, starch, etc.).
  • those of ordinary skill in the art of preparing nutritional formulations can readily formulate nutritional compositions having fig plant extracts.
  • those of ordinary skill in the art of preparing food or food ingredient formulations can readily formulate food compositions or food ingredient compositions having fig plant extracts.
  • the fig leaves extract can be lyophilized and re-dissolved in either cold or warm water, or be made into tablets, capsules, syrups and the like prior to being given to a subject. This procedure could simplify the availability of the treatment.
  • fig plant such as the bark, root, stem, leaves, flowers, fruit, seeds, branches, stalks and/or parts or mixtures thereof can be used for the preparation of the extract intended for the prevention and/or treatment of BPH and/or its symptoms.
  • an extract from fig leaves can be fractionated by HPLC (or other methods) to separate fractions and the most effective fractions, having desired activity, can be used for the prevention and/or treatment of BPH and/or its symptoms.
  • the present invention further provides the composition of the invention for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
  • the present invention provides the composition of the invention comprising fig leaves for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia
  • the present invention further provides a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia comprising administering to a subject in need of such treatment a therapeutically effective amount of the composition of the present invention.
  • a subject is a human male.
  • the terms "subject" or "patient” are well-recognized in the art, and, are used herein to refer to a mammal, and most preferably a human male.
  • the subject is a subject in need of treatment or a subject suffering from benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
  • the subject can be a normal subject who has not yet developed typical benign prostatic hyperplasia and/or typical benign prostatic hyperplasia symptoms. The term does not denote a particular age.
  • composition of the present invention may be formulated and administered by those skilled in the art in a manner and in an amount appropriate for the condition to be treated; the weight, age and health of the subject; the biochemical nature, bioactivity, bioavailability and side effects of the particular compound; and in a manner compatible with concurrent treatment regimens.
  • An appropriate amount and formulation for preventing and/or treating BPH and/or symptoms of benign prostatic hyperplasia in humans may be extrapolated for example based on the activity of the compound in the assays and animal models known in the art of a specific cancer or proliferative disorder.
  • the effective amount may be chosen to be more or less effective than a particular chemotherapeutic agent.
  • an amount of the composition suitable for a daily dose may be equivalent to about 0.01 to 100 grams of composition per kilogram body weight of the subject.
  • the daily dose may be about 1 to about 1,000 mg of dry extract per kg body weight.
  • the person skilled in the art may be able to titrate the dose necessary to achieve the desired effect and may likewise recognize that upward or downward deviations from the cited ranges may be tolerated within the scope of the present invention.
  • the present invention also encompasses various known pharmaceutically acceptable carriers and/or additives which may be incorporated into the composition of the present invention to enhance its stability. Further, antimicrobial preservatives, antioxidants, chelating agents, and additional buffers may be added. Various antibacterial and antifungal agents such as, for example, parabens, chlorobutanol, phenol, sorbic acid, and the like may enhance prevention of the action of microorganisms. In certain embodiment, isotonic agents, for example, sugars, sodium chloride, and the like may be included in the composition. Additionally, thickening agents such as methylcellulose may be used.
  • the present fig plant material extracts may also be employed either alone or in combination with other compounds as a part of combination therapy, partially or completely, in place of other conventional BPH therapies.
  • a drug or drugs and a nutraceutical such as a fig plant extract of the present invention, in a manner such that the drug and the nutraceutical have different mechanisms of action, but yet target the same disease.
  • Urinary tract infection was excluded by urinalysis and urine culture, diabetes melitus was excluded by fasting blood sugar and glucose tolerance tests, and diabetes insipidus was excluded by checking urine osmolality (and other related tests).
  • Ultrasound examination of prostate gland was compatible with the diagnosis of BPH. Finasteride 5mg tablet once per day was administered by the patient's urologist. Symptoms were significantly ameliorated a few weeks after finasteride treatment and the patient remained symptomless during one year while he received the once daily finasteride tablets. However, the recurrence of symptoms
  • Urinary tract infection was excluded by urinalysis and urine culture, diabetes melitus was excluded by fasting blood sugar and glucose tolerance tests, and diabetes insipidus was excluded by checking for urine osmolality (and other related tests).
  • BPH benign prostatic hyperplasia
  • Group I 0.5 g of Ficus Afghanistanica dried leaf in the form of tea bag. Two times per day, in the morning and in the evening, a tea bag was placed during 5 minutes in 150 ml of hot (boiled) water and the infusion was taken orally by the patient during a 3 month period.
  • Group II 0.5 g of Ficus Carica (common fig) dried leaf in the form of tea bag. Two times per day, in the morning and in the evening, a tea bag was placed during 5 minutes in 150 ml of hot (boiled) water and the infusion was taken orally by the patient during a 3 month period.
  • Ficus Carica common fig
  • Group III capsules containing 50 mg glucose. Capsules were taken orally two times per day (two capsules per day) during a 3 month period and served as the placebo. All patients were blinded to the treatment identifications.
  • a clinician blinded to the treatment identifications, determined the symptom score of each patient just before starting the treatment, one month after starting the treatment and finally 3 months after starting the treatment.
  • the severity of each symptom was graded from 0 to 5 : 0 representing the absence of the symptom and 5 representing the symptom in its severest form. Evaluated symptoms were as follows: Frequency of urination, Dysuria, Nocturia, Dribbling, Urgency, Weak urine flow, Hesitancy
  • the sum of symptom scores was determined for each patient during the evaluations.
  • the symptom score of each group was then determined through adding up the symptom scores of all patients in the same group.

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Abstract

The present invention relates to a composition comprising an extract of fig plant material, preferably extract of fig leaves, and the use thereof in a method of preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.

Description

COMPOSITION COMPRISING A FIG PLANT MATERIAL EXTRACT AND USE THEREOF IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
FIELD OF THE INVENTION
The present invention relates to a composition comprising an extract of fig plant material, preferably extract of fig leaves, and the use thereof in a method of preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
BACKGROUND OF THE INVENTION Prostatic Hyperplasia (BPH, also called benign prostatic hypertrophy) is characterized by hyperplasia of prostatic stromal and epithelial cells, resulting in the formation of large, fairly discrete nodules, in the periurethral region of the prostate. When sufficiently large, the nodules compress the urethral canal to cause partial or sometimes complete obstruction of the urethra which interferes the normal flow of urine. The symptoms of BPH vary, but the most common ones involve changes in, or problems with, urination, such as urinary hesitancy, dysuria (painful urination), urinary interruption, weak stream, urgency and leaking or dribbling as well as more frequent urination especially at night. The size of the prostate does not always determine how severe the obstruction or the symptoms will be. Some men with greatly enlarged glands have little obstruction and few symptoms while others, whose glands are less enlarged, have more blockage and greater problems. Sometimes a man may not know he has any obstruction until he suddenly finds himself unable to urinate at all. This condition, called acute urinary retention, may be triggered by taking over-the-counter cold or allergy medicines. Such medicines contain a decongestant drug, known as a sympatho-mimetic. A potential side effect of this drug may prevent the bladder opening from relaxing and allowing urine to empty. When partial obstruction is present, urinary retention also can be brought on by alcohol, cold temperatures, or a long period of immobility. BPH can already begin at the age of 30 years. An estimated 50% of men have histologic evidence of BPH by age 50 years and 75% by age of 80 years. If BPH is not symptomatic it is usually not treated and the patient is just regularly followed by the physician. When symptoms of BPH begin to appear medical treatments are used. These include the administration of alpha- 1 blockers (for example Tamsulosine, Alfuzosine and Terazosine), 5-alpha reductase inhibitors (Finasteride and Dutasteride) and sometimes anticholinergics. These medications, however, can cause several side effects such as changes in blood pressure in the case of alpha- 1 blockers, erectile impotence (inability to have penile erection), and decrease of libido in the case of 5-alpha reductase inhibitors, and dizziness, dry mouth and syncope in the case of anticholinergics. If medical treatments prove ineffective to remove the symptoms of BPH, surgical treatment is usually indicated. Such a surgical treatment can be associated with side effects as haemorrhage, post surgical infections and permanent erectile impotence.
These numerous side effects of the medical treatments used for BPH have caused people to search for alternative treatments for this disease. A number of plant and herbal extracts and mixtures have been used for the treatment of BPH. One of the most well known plants used is Saw palmetto {Serenoa repens). There was early promising evidence that Saw Palmetto can help shrink the size of prostate (Boyle P; Robertson C; Lowe F; Roehrborn C (April 2000). "Meta-analysis of clinical trials of permixon in the treatment of symptomatic benign prostatic hyperplasia". Urology 55 (4): 533-9). However, later trials of higher methodological quality indicated no difference from placebo (Bent S, Kane C, Shinohara K, et al. (February 2006). "Saw palmetto for benign prostatic hyperplasia". N. Engl. J. Med. 354 (6): 557-66., Dedhia RC, McVary KT (June 2008). "Phytotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia". J. Urol. 179 (6): 2119-25., Wilt T, Ishani A, Mac Donald R (2002). "Serenoa repens for benign prostatic hyperplasia". Cochrane Database Svst Rev (3): CD001423.).
Other herbs and nutrients have been claimed to assist in alleviating BPH symptoms, and these include Pyguem africanum, the root of the stinging nettle (Urtica dioica), pumpkin seed (Cucurbita pepo), beta-Sitosterol from Hypoxis rooperi (African star grass). Other elements, such as green tea extract, selenium, lycopene, pollen extracts, rye grass (Secale cereale) may also correlate with symptomatic relief (Wilt T; Mac Donald R; Ishani A; Rutks I; Stark G (2000). "Cernilton for benign prostatic hyperplasia". Cochrane Database Syst Rev (2): CD001042). These herbal treatments are usually considered safe but also generally less effective than the medical treatments.
Thus there is still a need to develop effective and safe compositions for prevention and/or treatment of BPH.
SUMMARY OF THE INVENTION
The present invention provides a composition comprising an extract of fig leaves. Further the present invention provides the composition of the invention for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
DETAILED DESCRIPTION OF THE INVENTION Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. The publications and applications discussed herein are provided solely for their disclosure prior to the filing date of the present application.
Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting.
In the case of conflict, the present specification, including definitions, will control.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in art to which the subject matter herein belongs. As used herein, the following definitions are supplied in order to facilitate the understanding of the present invention. The term "comprise" is generally used in the sense of include, that is to say permitting the presence of one or more features or components. As used in the specification and claims, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.
The present invention provides a composition for preventing and/or treating benign prostatic hyperplasia comprising an extract of fig leaves.
The terms "treatment", "treating", "treat" and the like are used herein to generally refer to obtaining a desired pharmacologic and/or physiologic effect in a mammal, particularly in a human male. The effect (a) may be prophylactic in terms of completely or partially preventing a disease or symptom of Benign Prostatic Hyperplasia from occurring in a subject which may be predisposed to the disease or symptom but has not yet been diagnosed as having it and/or (b) may be therapeutic in terms of a partial or complete stabilization, cure or inhibition of Benign Prostatic Hyperplasia symptom i. e., arresting its development; and/or relieving Benign Prostatic Hyperplasia symptom, i. e., causing regression of the disease or symptom.
The extract of fig leaves of the present invention is used to prevent and/or treat Benign Prostatic Hyperplasia (BPH, also called benign prostatic hypertrophy) and/or symptoms of benign prostatic hyperplasia. Said treatment also includes alleviation of the symptoms commonly associated with Benign Prostatic Hyperplasia, wherein the alleviation of symptoms may or not be associated with a decrease in the size of a hypertrophied prostate gland.
Benign prostatic hyperplasia symptoms are usually classified as storage or voiding.
Storage symptoms include urinary frequency, urgency (compelling need to void that cannot be deferred), urgency incontinence, and voiding at night (nocturia). Voiding symptoms include urinary stream, hesitancy (needing to wait for the stream to begin), intermittency (when the stream starts and stops intermittently), weak urine flow, straining to void, and dribbling. Pain and dysuria may be also included in benign prostatic hyperplasia symptoms.
Fig trees (Family: Moraceae, Tribe: Ficeae, Genus: Ficus) including the common fig {Ficus carica), are large deciduous shrubs or small trees native to southwest Asia and the
Mediterranean region from Afghanistan to Portugal. Ficus Afghanistanica known as the wild mountain fig, is native to Afghanistan, Iran and Pakistan but can also be found in Bavaria in Germany. The leaves of fig trees are 12-25 cm long and 10-18 cm across, and are deeply lobed, with 3 to 5 lobes. The fruit, known as a fig, is a good source of potassium, a mineral that helps to control blood pressure. Figs are also one of the highest sources of dietary fibre and are shown to reduce the incidence of breast cancer in a study involving 51,823 postmenopausal women (International Journal of Cancer, 2008. Jan. 15; 122(2):403-12).
CN101104013 has shown that extracts of fig leaves have anti-diabetic properties, reducing the amount of insulin needed by diabetics. Amongst other known uses of fig leaves and extracts of same include Bronchitis, cardiovascular problems, cancer, genital warts, haemorrhoids, liver cirrhosis, lowering blood pressure, ringworm, scalp fungal infections, shingles and ulcers.
As used herein, the term "extract" means a composition prepared by method comprising contacting an extraction medium with fig plant material under conditions suitable for drawing one or more chemical compounds from the fig plant material into the extraction medium, thereby forming an extraction solution. The extraction solution may then be separated from the fig plant material, and may optionally be diluted or reduced or dried, to form the extract, for example liquid extract or solid (such as powder) extract. An extract may be purified or substantially purified. Preferably the extraction medium is aqueous medium. Most preferably the extraction medium is water.
As used herein "substantially purified" means substantially free of contaminants which are associated with the fig plant material in its native environment. Purification may be
accomplished by either reducing the content of at least one of the components (including impurities) in the unpurified composition as compared to the level before purification or enriching the concentration of one or more components of interest in the composition as compared to the composition before purification. Plant material means any part or parts of at least one plant from the Ficus species, preferably Ficus Afghanistanica. Fig plant material may include the whole plant or any part or parts of the plant, such as the bark, root, stem, leaves, flowers, fruit, seeds, branches, stalks and/or parts or mixtures thereof. Preferably the fig plant material are leaves. Fig plant material may be fresh cut, dried (including freeze dried), frozen and the like. Fig plant material may also be whole or separated into small parts. For example, leaves may be chopped, shredded or ground; roots may be chopped or ground; fruit may be chopped, sliced or blended; seeds may be chopped or ground; stems may be shredded, chopped or ground. Thus, a biologically active extract contained in a composition of the present invention may be made using various portions of the fig plant, such as bark, roots, stems, leaves and combinations thereof. Preferably a biologically active extract contained in a composition of the present invention is made by using leaves.
The Examples herein describe use of Ficus Afghanistanica extracts prepared using leaves. Similar extracts made from other parts of the fig plant may also be useful in the methods described herein.
Thus the present invention provides a composition comprising an extract of fig plant material, preferably an extract of fig leaves. Preferably said fig plant material, more preferably said fig leaves, are obtained from Ficus species selected from the group comprising
Ficus afghanistanica,
Ficus abutilifolia (Miq.) Miq. (= F. soldanella Warb.)
Ficus adhatodifolia Schott
Ficus aguaraguensis
Ficus albert- smithii
Ficus albipila— Abbey Tree, Phueng Tree, tandiran
Ficus altissima
Ficus amazonica
Ficus americana
Ficus andamanica
Ficus angladei
Ficus apollinaris Dugand (= F. petenensis Lundell)
Ficus aripuanensis
Ficus arpazusa
Ficus aspera
Ficus aspera var. parcelli
Ficus aurea— Florida Strangler Fig
Ficus auriculata— Roxburgh Fig
Ficus barbata— Bearded Fig
Ficus battieri
Ficus beddomei— Thavital
Ficus benghalensis— Indian Banyan, Bengal Fig, East Indian Fig, borh (Pakistan), vad/vat/wad, nyagrodha, "indian fig"
Ficus benjamina— Weeping Fig, Benjamin 's Fig
Ficus bibracteata
Ficus bizanae
Ficus blepharophylla
Ficus bojeri
Ficus broadwayi
Ficus bubu Warb.
Ficus burtt-davyi Hutch.
Ficus calyptroceras
Ficus capreifolia Del.
Ficus carchiana C. C.Berg Ficus carica— Common Fig, anjeer (Iran, Pakistan), dumur (Bengali) Ficus castellviana
Ficus catappifolia
Ficus citrifolia— Short-leaved Fig, Wild Banyantree
Ficus clusiifolia
Ficus congesta
Ficus cordata Thunb.
Ficus cordata ssp. salicifolia (Vahl) Berg
Ficus coronata— Creek Sandpaper Fig
Ficus costaricana (Liebm.) Miq.
Ficus cotinifolia
Ficus crassipes— Round-leaved Banana Fig
Ficus crassiuscula Standi.
Ficus craterostoma Warb. ex Mildbr. & Burr.
Ficus cristobalensis
Ficus cyclophylla
Ficus dammaropsis— Highland Breadfruit, kapiak (Tok Pisin)
Ficus dendrocida
Ficus deltoidea— Mistletoe Fig
Ficus destruens
Ficus drupacea
Ficus ecuadorensis C.C.Berg
Ficus elastica— Indian Rubber Plant, Rubber Fig, "rubber tree", "rubber plant" Ficus elastica cv. 'Decora '
Ficus elastica var. variegata
Ficus elasticoides
Ficus elliotiana
Ficus enormis
Ficus erecta— Japanese fig
Ficus faulkneriana
Ficus fischeri Warb. ex Mildbr. & Burr. (= F. kiloneura Hornby)
Ficus fistulosa
Ficus fraseri— Shiny Sandpaper Fig, White Sandpaper Fig, "figwood", "watery fig"
Ficus fulvo-pilosa Summerh.
Ficus gardneriana
Ficus gibbosa
Ficus gigantosyce Dugand
Ficus gilletii
Ficus glabra
Ficus glaberrima
Ficus glumosa (Miq.) Del. (=F. sonderi Miq.)
Ficus godefiroyi (endemic to Samoa, known as Mati.)
Ficus gomelleira
Ficus greenwoodii Summerh.
Ficus greijfiana
Ficus grenadensis
Ficus grossularioides— White-leaved Fig
Ficus guajavoides Lundell
Ficus guaranitica[ 17] Ficus guianensisflSJ
Ficus hartii
Ficus hebetifolia
Ficus hederacea
Ficus heterophylla
Ficus hirsuta
Ficus hirta Vahl
Ficus hispida
Ficus hispita L.
Ficus ilicina (Sond.) Miq.
Ficus illiberalis
Ficus insipida
Ficus insipida ssp. insipida
Ficus insipida ssp. scabrak
Ficus kerkhovenii— Johore Fig
Ficus luschnathiana (Miq.) Miq.
Ficus infectoria— Wavy-leaved Fig, plaksa
Ficus ingens (Miq.) Miq.
Ficus krukovii
Ficus lacor
Ficus lacunata
Ficus laevigata
Ficus laevis
Ficus lapathifolia
Ficus lateriflora
Ficus lauretana
Ficus loxensis C.C.Berg
Ficus lutea Vahl (= F. vogelii, F. nekbudu, F. quibeba Welw. ex Fical.)
Ficus lyrata— Fiddle-leaved Fig
Ficus macbridei Standi.
Ficus maclellandii— Alii Fig or Banana-Leaf Fig
Ficus macrocarpa
Ficus macrophylla— Moreton Bay Fig
Ficus magnifolia
Ficus malacocarpa
Ficus mariae
Ficus masonii Home ex Baker
Ficus mathewsii
Ficus matiziana
Ficus mauritiana
Ficus maxima
Ficus maximoides C.C.Berg
Ficus meizonochlamys
Ficus mexiae
Ficus microcarpa— Chinese Banyan, Malayan Banyan, Curtain Fig, "Indian laurel" Ficus microcarpa var. hillii— Hill's Fig
Ficus microcarpa var. nitida— often considered a subspecies of F. retusa or a distinct species
Ficus microchlamys Ficus minahasae— longusei (Sulawesi)
Ficus mollior F.Muell. ex Benth.
Ficus monckii
Ficus montana— Oakleaf Fig
Ficus muelleri
Ficus muelleriana
Ficus mutabilis
Ficus mutisii Dugand
Ficus mysorensis
Ficus natalensis Hochst.— mutuba (Luganda)
Ficus natalensis ssp. leprieurii
Ficus natalensis ssp. natalensis
Ficus neriifolia
Ficus nervosa
Ficus noronhae
Ficus nota— tibig
Ficus nymphaeifolia
Ficus oapana C. C.Berg
Ficus obliqua— Small-leaved Fig
Ficus obtusifolia
Ficus obtusiuscula (Miq.) Miq.
Ficus opposita— Sweet Sandpaper Fig, Sweet Fig, "figwood", "watery fig"
Ficus organensis (Miq.) Miq.
Ficus padifolia
Ficus pakkensis
Ficus pallida
Ficus palmata
Ficus pandurata
Ficus pantoniana— Climbing Fig
Ficus panurensis
Ficus pertusa
Ficus petiolaris (= F. palmeri)
Ficus pilosa
Ficus piresiana Vdzq.Avila & C. C.Berg
Ficus platypoda— Desert Fig, Rock Fig
Ficus pleurocarpa— Banana Fig, Gobi Fig, Karpe Fig
Ficus polita Vahl
Ficus polita ssp. polita
Ficus prolixa G.Forst. (= F. mariannensis Merr.)
Ficus pseudopalma Blanco
Ficus pulchella
Ficus pumila— Creeping Fig
Ficus pumila var. awkeotsang
Ficus pyriformis
Ficus racemosa— Cluster Fig, Goolar Fig, udumbara (Sanskrit), umbar (India) Ficus ramiflora
Ficus religiosa— Sacred Fig, arali, bo, pipal, pippala, pimpal (etc.), pou (Cambodia), Ashvastha
Ficus retusa— Taiwan Fig, Ginseng Fig, "Indian laurel", "Cuban-laurel" Ficus rieberiana C.C.Berg
Ficus roraimensis
Ficus roxburghii
Ficus rubiginosa— Port Jackson Fig, Little-leaved Fig, Rusty Fig, damun (Sydney Language)
Ficus rumphii Blume— R mpfs Fig
Ficus salicifolia Vahl (= F. pretoriae Burtt Davy)— Willow-leaved Fig
Ficus salzmanniana
Ficus sansibarica Warb.
Ficus sarmentosa
Ficus saussureana
Ficus scabra G.Forst.
Ficus schippii
Ficus schultesii
Ficus schumacheri
Ficus septica Burm. F. var. septica Moraceae— Hauli Tree in Philippines
Ficus sphenophylla
Ficus stahlii
Ficus stuhlmannii Warb.
Ficus subpuberula
Ficus superba
Ficus superba var. henneana
Ficus sur Forssk. (= F. capensis)
Ficus sycomorus— Sycamore Fig, Fig-mulberry
Ficus sycomorus ssp. sycomorus
Ficus sycomorus ssp. gnaphalocarpa (Miq.) C.C. Berg
Ficus tettensis Hutch. (= F. smutsii Verdoorn)
Ficus thonningii
Ficus tinctoria— Dye Fig, Humped Fig
Ficus tobagensis
Ficus tomentella
Ficus tomentosa
Ficus tonduzii Standi.
Ficus tremula Warb.
Ficus tremula ssp. tremula
Ficus triangularis
Ficus trichopoda Bak. (= F. hippopotami Gerstn.)
Ficus trigona L.f.
Ficus trigonata
Ficus triradiata— Red-stipule Fig
Ficus ulmifolia
Ficus umbellata
Ficus ursina
Ficus variegata Bl.
Ficus variegata var. chlorocarpa King
Ficus variolosa
Ficus velutina
Ficus verruculosa Warb.
Ficus virens— White Fig, pilkhan, an-borndi (Gun-djeihmi) Ficus virens var. sublanceolata White Fig, New South Wales
Ficus virgata
Ficus wassa
Ficus watkinsiana— Watkins' Fig, Nipple Fig, Green-leaved Moreton Bay Fig
Ficus yoponensis Desv.
Preferably fig leaves are obtained from Ficus afghanistanica.
The extract of fig plant material, preferably the extract of fig leaves, can be a liquid extract or a solid extract (such as powder). Preferably a liquid extract is an aqueous liquid extract.
The composition of the invention can be in the form of liquid tea, beverage, tincture, ampoule, gel and/or syrup as well as in the form of dry tea, capsule, pill and/or tablet. In an embodiment, the composition of the present invention can contain only the extract of fig plant material, preferably extract of fig leaves.
In another embodiment of the present invention, fig leaves can be dried using a number of procedures which include, but not limited to, air drying, oven drying, or microwave drying. Air drying: Simply tying the fig leaves in bunches and hanging them upside-down in a dark and dry place, at about 20 - 25 °C. Depending on what kind fig leaves, it can take a few days and up to weeks for them to dry completely. Oven drying: The fig leaves are put on a sheet in a thin layer and are placed in a low setting oven. Microwave drying: The fig leaves are put on a plate and the microwave is set on low. Depending to the microwave, this may take from 2 to 5 minutes.
Once the fig leaves are dried, they can be crushed to make a tea-like composition and placed in « fig leaf » tea bags. To make the BPH preventing and/or treating fig leaf tea, a fig leaf tea bag should be immersed in hot, but preferably not boiling water for a few minutes, prior to consumption of the fig leaf tea.
In a further embodiment, the composition of the invention is a beverage, which is a
substantially aqueous drinkable composition suitable for human consumption. The beverage will typically comprise at least 70% water, more preferably at least 80%, optimally between 85 and 99% by weight of the beverage. The total amount of extract of fig plant material, preferably extract of fig leaves, typically be from 0.001 to 5%, more preferably from 0.01 to 3% and most preferably from 0.1 to 1% by weight of the beverage.The beverage may contain other optional components such as a chelator, colorant, preservative (e.g., potassium sorbate, sodium benzoate or a mixture thereof), flavour, vitamin, sweetener (e.g, corn syrup, sucrose or a mixture thereof), fruit juice, surfactant (e.g, sorbitan monolaurate, sorbitan monopalmitate or a mixture thereof), acidulant, non-fat milk solids, fat (e.g. milk fat, vegetable fat or a mixture thereof) or mixtures thereof. When employed, such optional components collectively make up less than 25.0% by weight of the total weight of the beverage composition, typically between 0.001% and 10%. The beverage may be still or carbonated.
In a preferred embodiment, the composition of the present invention is a tea. To extract fig leaves into a tea, usually a few fresh leaves or dried leaves are used. Preferably a fig leaf tea bag is used. The leaves can be macerated briefly in a mortar and pestle or crushed in a bowl. Then the leaves are placed for example into a teacup and boiling or hot water is poured over the leaves. The tea is allowed to steep for 10 minutes, preferably 5 to 7 minutes, and then it is strained (for example filtered) and finally it is ready to drink. To save time and effort, a larger amount of tea can be made and the leftovers can be stored for example in refrigerator for up to five days, preferably two days. Usually, tea can contain an amount of fresh or dried fig leaves/water from about 0.001% to about 99% by weight, preferably from about 0.01% to about 80% by weight.
In another embodiment, the composition of the present invention can be a tincture, which is also made from fig leaves and which can be used either fresh or dried. Tinctures can be made from liquids such as vodka, rum, brandy, vinegar or vegetable glycerine, but alcohol yields the strongest concentration of the fig's ingredients. Only a small amount is taken, so the alcohol will have no noticeable effect on the consciousness of a subject. It's convenient to make at least 500 ml of tincture because the brewing process can take one month. A 500 ml glass jar is filled one-third full with rinsed, chopped fig leaves, and then it is filled with a liquid such as vodka, rum, brandy, vinegar or vegetable glycerine. The mixture is tightly caped and shacked daily for one month. The mixture should be stored out of the sun. After one month, the liquid is strained. The tincture is taken by the full dropper and usually two to four droppers per administration are sufficient. An extract of fig leaves can be also an aqueous extraction of fig leaves which is filtered, concentrated, and optionally extracted with further organic solvents. The extract can be further air-dried under vacuum, optionally dissolved in ethanol, and filtered. The final extract of fig leaves is obtained after ethanol was evaporated under vacuum.
An extract of fig leaves can be further an organic extract. In order to prepare the organic extract, fig leaves are preferably ground into a fine powder, the resultant powder is extracted with a solvent, and the extraction solvent is removed from the extract. The whole fig plant or parts other than leaves may be used. If desired, the resultant extract may be further purified to yield a purified extract or one or more purified compositions. The grinding step may be accomplished by any commonly known method for grinding a plant substance. For example, the plant or parts thereof may be passed through a grinder to obtain a fine powder. After the plant or parts thereof have been ground into a fine powder, they are combined with an extraction solvent. The solution is then stirred at a temperature, and for a period of time, that is effective to obtain an extract with the desired activity. The solution is preferably not overheated, as this may result in degradation and/or denaturation of compounds in the extract. The solution may be stirred at a temperature between about room temperature (25° C) and the boiling point of the extraction solvent. Preferably, the solution is stirred at about room temperature. The length of time during which the plant powder is exposed to the extraction solvent is not critical. Up to a point, the longer the plant powder is exposed to the extraction solvent, the greater is the amount of extract that may be recovered. Preferably, the solution is stirred for at least 1 minute, more preferably for at least 15 minutes, and most preferably for at least 60 minutes. The extraction process of the present invention is desirably carried out using an organic solvent or a mixture of organic solvents. Organic solvents which may be used in the extraction process of the present invention, include but are not limited to hydrocarbon solvents, ether solvents, chlorinated solvents, acetone, ethyl acetate, butanol, ethanol, methanol, isopropyl alcohol and mixtures thereof.
In other embodiments of the present invention the fig plant material, preferably fig leaves can be converted into other formulations than tea. Formulations such as pills, capsules, syrups, ampoules, gels, and other forms suitable for administration, containing the fig plant material extract, preferably fig plant leaves extract, can be employed. Those of ordinary skill in the art of preparing pharmaceutical formulations can readily formulate pharmaceutical compositions having fig plant extracts using known excipients (e. g., saline, glucose, starch, etc.).
Similarly, those of ordinary skill in the art of preparing nutritional formulations can readily formulate nutritional compositions having fig plant extracts. And those of ordinary skill in the art of preparing food or food ingredient formulations can readily formulate food compositions or food ingredient compositions having fig plant extracts.
In yet another embodiment of the present invention, the fig leaves extract can be lyophilized and re-dissolved in either cold or warm water, or be made into tablets, capsules, syrups and the like prior to being given to a subject. This procedure could simplify the availability of the treatment.
In another embodiment of the present invention other parts of the fig plant such as the bark, root, stem, leaves, flowers, fruit, seeds, branches, stalks and/or parts or mixtures thereof can be used for the preparation of the extract intended for the prevention and/or treatment of BPH and/or its symptoms.
In a further embodiment of the present invention, an extract from fig leaves can be fractionated by HPLC (or other methods) to separate fractions and the most effective fractions, having desired activity, can be used for the prevention and/or treatment of BPH and/or its symptoms.
The present invention further provides the composition of the invention for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia. Preferably the present invention provides the composition of the invention comprising fig leaves for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia
The present invention further provides a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia comprising administering to a subject in need of such treatment a therapeutically effective amount of the composition of the present invention. Preferably said subject is a human male. As used herein the terms "subject" or "patient" are well-recognized in the art, and, are used herein to refer to a mammal, and most preferably a human male. In some embodiments, the subject is a subject in need of treatment or a subject suffering from benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia. However, in other embodiments, the subject can be a normal subject who has not yet developed typical benign prostatic hyperplasia and/or typical benign prostatic hyperplasia symptoms. The term does not denote a particular age.
The composition of the present invention may be formulated and administered by those skilled in the art in a manner and in an amount appropriate for the condition to be treated; the weight, age and health of the subject; the biochemical nature, bioactivity, bioavailability and side effects of the particular compound; and in a manner compatible with concurrent treatment regimens. An appropriate amount and formulation for preventing and/or treating BPH and/or symptoms of benign prostatic hyperplasia in humans may be extrapolated for example based on the activity of the compound in the assays and animal models known in the art of a specific cancer or proliferative disorder. The effective amount may be chosen to be more or less effective than a particular chemotherapeutic agent. Thus, an amount of the composition suitable for a daily dose may be equivalent to about 0.01 to 100 grams of composition per kilogram body weight of the subject. For example, the daily dose may be about 1 to about 1,000 mg of dry extract per kg body weight. The person skilled in the art may be able to titrate the dose necessary to achieve the desired effect and may likewise recognize that upward or downward deviations from the cited ranges may be tolerated within the scope of the present invention.
The present invention also encompasses various known pharmaceutically acceptable carriers and/or additives which may be incorporated into the composition of the present invention to enhance its stability. Further, antimicrobial preservatives, antioxidants, chelating agents, and additional buffers may be added. Various antibacterial and antifungal agents such as, for example, parabens, chlorobutanol, phenol, sorbic acid, and the like may enhance prevention of the action of microorganisms. In certain embodiment, isotonic agents, for example, sugars, sodium chloride, and the like may be included in the composition. Additionally, thickening agents such as methylcellulose may be used.
The present fig plant material extracts, preferably fig leaves extract, may also be employed either alone or in combination with other compounds as a part of combination therapy, partially or completely, in place of other conventional BPH therapies. Preferably, with combination therapy, one will typically combine a drug or drugs and a nutraceutical, such as a fig plant extract of the present invention, in a manner such that the drug and the nutraceutical have different mechanisms of action, but yet target the same disease.
Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications without departing from the spirit or essential characteristics thereof. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features. The present disclosure is therefore to be considered as in all aspects illustrated and not restrictive, the scope of the invention being indicated by the appended Claims, and all changes which come within the meaning and range of equivalency are intended to be embraced therein.
The foregoing description will be more fully understood with reference to the following Examples. Such Examples, are, however, exemplary of methods of practising the present invention and are not intended to limit the scope of the invention. EXAMPLES
Example 1
A 68 year old male patient developed symptoms such as urination frequency, urgency, nocturia and dribbling. Urinary tract infection was excluded by urinalysis and urine culture, diabetes melitus was excluded by fasting blood sugar and glucose tolerance tests, and diabetes insipidus was excluded by checking urine osmolality (and other related tests). Ultrasound examination of prostate gland was compatible with the diagnosis of BPH. Finasteride 5mg tablet once per day was administered by the patient's urologist. Symptoms were significantly ameliorated a few weeks after finasteride treatment and the patient remained symptomless during one year while he received the once daily finasteride tablets. However, the recurrence of symptoms
(urination frequency, urgency, nocturia and dribbling) began to occur 1 year after commencing the finasteride treatment and while the patient was still continuing this treatment. Urinary tract infection, diabetes melitus and diabetes insipidus were again excluded by related tests at this time. Benign prostatic hypertrophy was again confirmed by sonography and other related tests. The treatment by finasteride was discontinued due to the lack of amelioration of symptoms and the patient was scheduled for prostate surgery. The patient continued to have the above mentioned symptoms during the weeks following finasteride discontinuation and before any surgery. The patient was given, twice daily, in the morning and evening, an extract of the dried leaves of Ficus afghanistanica. This extract was prepared each time by soaking 1 gr. of the dried leaves during 5 minutes in 100 ml hot water. A few days following the twice daily drinking of the Ficus afghanistanica leaf extract, the symptoms (urination frequency, urgency, nocturia and dribbling) began to diminish and disappeared fully after 2 weeks of continuous treatment with this extract. The patient has continued to use the extract for more than one year of treatment and has remained completely symptomless, during this period. No prostate surgery has ever been performed on the patient and the patient has not been simultaneously treated with any other BPH treatments. Discontinuation of the leaf extract treatment by the patient during a two week period caused the return of the urinary symptoms after a few days of such a discontinuation. Re-starting the treatment with the Ficus afghanistanica leaf extract caused the symptoms to disappear within less than one week. No side effects occurred during the treatment period with the Ficus afghanistanica leaf extract. The patient continues to take the leaf extract every day. Example 2
A 56 year old male patient developed symptoms such as urination frequency, urgency, nocturia and dribbling. Urinary tract infection was excluded by urinalysis and urine culture, diabetes melitus was excluded by fasting blood sugar and glucose tolerance tests, and diabetes insipidus was excluded by checking for urine osmolality (and other related tests). Ultrasound
examination of prostate gland was compatible with the diagnosis of Benign prostatic hypertrophy. Finasteride 5mg tablet once per day was administered by the patient's urologist and ameliorated the symptoms after some weeks of administration. The patient, however, developed an erectile impotence about 3 months after the treatment with finasteride and thus discontinued the treatment due to this side effect. Symptoms of Benign prostatic hypertrophy returned after the discontinuation of finasteride treatment. The patient tried several plant based traditional medicine treatments, such as green tea extract, ginko biloba extract etc. to ameliorate the symptoms. None of these treatments were effective for the amelioration of his symptoms (urination frequency, dysuria, urgency, nocturia and dribbling). These treatments were thus discontinued by the patient. Two months after the discontinuation of these treatments, and while the patient still suffered from all the above mentioned symptoms, the patient was given, twice daily, in the morning and evening, an extract of the dried leaves of Ficus afghanistanica. This extract was prepared each time by soaking 1 gr. of the dried leaves, placed during 5 minutes in 100 ml hot water. A few days following the twice daily drinking of the Ficus afghanistanica leaf extract, the symptoms (urination frequency, dysuria, urgency, nocturia and dribbling) began to ameliorate and disappeared fully after 10 days of continuous treatment with this leaf extract. The patient has continued to use the extract for more than one year now, and has remained completely symptomless, during this period. No erectile impotence occurred at any time during the treatment with the Ficus afghanistanica extract. The patient experienced no side effects during the treatment with the leaf extract. No prostate surgery has ever been performed on the patient and the patient has not simultaneously been treated with any other BPH treatments. The patient continues to take the leaf extract every day. Example 3
30 patients with symptomatic benign prostatic hyperplasia (BPH) were enrolled in the clinical trial. The BPH was confirmed by sonographic examination in all patients. Diabetes mellitus, diabetes insipidus and urinary tract infection were excluded in all cases through relevant laboratory tests. None of patients had received any medication for the treatment of his BPH at least during the last 3 months before beginning the clinical trial. Patients were randomly placed into three groups of 10 patients each and received the following treatments:
Group I: 0.5 g of Ficus Afghanistanica dried leaf in the form of tea bag. Two times per day, in the morning and in the evening, a tea bag was placed during 5 minutes in 150 ml of hot (boiled) water and the infusion was taken orally by the patient during a 3 month period.
Group II: 0.5 g of Ficus Carica (common fig) dried leaf in the form of tea bag. Two times per day, in the morning and in the evening, a tea bag was placed during 5 minutes in 150 ml of hot (boiled) water and the infusion was taken orally by the patient during a 3 month period.
Group III: capsules containing 50 mg glucose. Capsules were taken orally two times per day (two capsules per day) during a 3 month period and served as the placebo. All patients were blinded to the treatment identifications.
A clinician, blinded to the treatment identifications, determined the symptom score of each patient just before starting the treatment, one month after starting the treatment and finally 3 months after starting the treatment. The severity of each symptom was graded from 0 to 5 : 0 representing the absence of the symptom and 5 representing the symptom in its severest form. Evaluated symptoms were as follows: Frequency of urination, Dysuria, Nocturia, Dribbling, Urgency, Weak urine flow, Hesitancy
The sum of symptom scores was determined for each patient during the evaluations. The symptom score of each group was then determined through adding up the symptom scores of all patients in the same group.
Results
Group I (treated with Ficus Afghanistanica):
Patient No. 1 2 3 4 5 6 7 8 9 10 Sum
Symptom 27 19 27 25 8 7 11 20 4 19 167 score before
the treatment
Symptom 13 6 8 17 5 4 2 17 3 3 78 score after 1
month of
treatment
Symptom 10 9 5 18 4 6 3 8 1 2 66 score after 3
months of
treatment Group II (treated with Ficus Carica):
Figure imgf000021_0001
Group III (placebo group treated with glucose capsules)
Patient No. 1 2 3 4 5 6 7 8 9 10 Sum
Symptom 13 5 12 9 12 13 9 9 7 26 115 score before
the treatment
Symptom 13 2 12 9 12 16 3 12 6 27 112 score after 1
month of
treatment
Symptom 14 3 7 11 15 12 4 13 5 25 109 score after 3
months of
treatment A statistically significant difference was found between the Group I and Group III (placebo) indicating that Ficus Afghanistanica was effective in reducing the symptoms of benign prostatic hyperplasia (p<0.05).
A statistically significant difference was also found between the Group I and Group II, indicating that Ficus Afghanistanica was significantly more effective than Ficus Carica in reducing the symptoms of benign prostatic hyperplasia (p<0.05).

Claims

1. A composition comprising an extract of fig plant material.
2. The composition of claim 1, wherein said fig plant material are fig leaves.
3. The composition of claim 1, wherein said fig plant material is obtained from Ficus species selected from the group comprising
Ficus afghanistanica,
Ficus abutilifolia (Miq.) Miq. (= F. soldanella Warb.)
Ficus adhatodifolia Schott
Ficus aguaraguensis
Ficus albert- smithii
Ficus albipila— Abbey Tree, Phueng Tree, tandiran
Ficus altissima
Ficus amazonica
Ficus americana
Ficus andamanica
Ficus angladei
Ficus apollinaris Dugand (= F. petenensis Lundell)
Ficus aripuanensis
Ficus arpazusa
Ficus aspera
Ficus aspera var. parcelli
Ficus aurea— Florida Strangler Fig
Ficus auriculata— Roxburgh Fig
Ficus barbata— Bearded Fig
Ficus battieri
Ficus beddomei— Thavital
Ficus benghalensis— Indian Banyan, Bengal Fig, East Indian Fig, borh (Pakistan), vad/vat/wad, nyagrodha, "indian fig"
Ficus benjamina— Weeping Fig, Benjamin 's Fig
Ficus bibracteata
Ficus bizanae
Ficus blepharophylla
Ficus bojeri
Ficus broadwayi
Ficus bubu Warb.
Ficus burtt-davyi Hutch.
Ficus calyptroceras
Ficus capreifolia Del.
Ficus carchiana C.C.Berg
Ficus carica— Common Fig, anjeer (Iran, Pakistan), dumur (Bengali)
Ficus castellviana Ficus catappifolia
Ficus citrifolia— Short-leaved Fig, Wild Banyantree
Ficus clusiifolia
Ficus congesta
Ficus cordata Thunb.
Ficus cordata ssp. salicifolia (Vahl) Berg
Ficus coronata— Creek Sandpaper Fig
Ficus costaricana (Liebm.) Miq.
Ficus cotinifolia
Ficus crassipes— Round-leaved Banana Fig
Ficus crassiuscula Standi.
Ficus craterostoma Warb. ex Mildbr. & Burr.
Ficus cristobalensis
Ficus cyclophylla
Ficus dammaropsis— Highland Breadfruit, kapiak (Tok Pisin)
Ficus dendrocida
Ficus deltoidea— Mistletoe Fig
Ficus destruens
Ficus drupacea
Ficus ecuadorensis C. C.Berg
Ficus elastica— Indian Rubber Plant, Rubber Fig, "rubber tree", "rubber plant"
Ficus elastica cv. 'Decora '
Ficus elastica var. variegata
Ficus elasticoides
Ficus elliotiana
Ficus enormis
Ficus erecta— Japanese fig
Ficus faulkneriana
Ficus fischeri Warb. ex Mildbr. & Burr. (= F. kiloneura Hornby)
Ficus fistulosa
Ficus fraseri— Shiny Sandpaper Fig, White Sandpaper Fig, "figwood", "watery fig" Ficus fulvo-pilosa Summerh.
Ficus gardneriana
Ficus gibbosa
Ficus gigantosyce Dugand
Ficus gilletii
Ficus glabra
Ficus glaberrima
Ficus glumosa (Miq.) Del. (=F. sonderi Miq.)
Ficus godeffroyi (endemic to Samoa, known as Mati.)
Ficus gomelleira
Ficus greenwoodii Summerh.
Ficus greiffiana
Ficus grenadensis
Ficus grossularioides— White-leaved Fig
Ficus guajavoides Lundell
Ficus guaranitica[ 17]
Ficus guianensis[18]
Ficus hartii Ficus hebetifolia
Ficus hederacea
Ficus heterophylla
Ficus hirsuta
Ficus hirta Vahl
Ficus hispida
Ficus hispita L.
Ficus ilicina (Sond.) Miq.
Ficus illiberalis
Ficus insipida
Ficus insipida ssp. insipida
Ficus insipida ssp. scabrak
Ficus kerkhovenii— Johore Fig
Ficus luschnathiana (Miq.) Miq.
Ficus infectoria— Wavy-leaved Fig, plaksa
Ficus ingens (Miq.) Miq.
Ficus krukovii
Ficus lacor
Ficus lacunata
Ficus laevigata
Ficus laevis
Ficus lapathifolia
Ficus lateriflora
Ficus lauretana
Ficus loxensis C. C.Berg
Ficus lutea Vahl (= F. vogelii, F. nekbudu, F. quibeba Welw. ex Fical.)
Ficus lyrata— Fiddle-leaved Fig
Ficus macbridei Standi.
Ficus maclellandii— Alii Fig or Banana-Leaf Fig
Ficus macrocarpa
Ficus macrophylla— Moreton Bay Fig
Ficus magnifolia
Ficus malacocarpa
Ficus mariae
Ficus masonii Home ex Baker
Ficus mathewsii
Ficus matiziana
Ficus mauritiana
Ficus maxima
Ficus maximoides C. C.Berg
Ficus meizonochlamys
Ficus mexiae
Ficus microcarpa— Chinese Banyan, Malayan Banyan, Curtain Fig, "Indian laurel" Ficus microcarpa var. hillii— Hill's Fig
Ficus microcarpa var. nitida— often considered a subspecies of F. retusa or a distinct species
Ficus microchlamys
Ficus minahasae— longusei (Sulawesi)
Ficus mollior F.Muell. ex Benth. Ficus monckii
Ficus montana— Oakleaf Fig
Ficus muelleri
Ficus muelleriana
Ficus mutabilis
Ficus mutisii Dugand
Ficus mysorensis
Ficus natalensis Hochst.— mutuba (Luganda)
Ficus natalensis ssp. leprieurii
Ficus natalensis ssp. natalensis
Ficus neriifolia
Ficus nervosa
Ficus noronhae
Ficus nota— tibig
Ficus nymphaeifolia
Ficus oapana C.C.Berg
Ficus obliqua— Small-leaved Fig
Ficus obtusifolia
Ficus obtusiuscula (Miq.) Miq.
Ficus opposita— Sweet Sandpaper Fig, Sweet Fig, "figwood", "watery fig"
Ficus organensis (Miq.) Miq.
Ficus padifolia
Ficus pakkensis
Ficus pallida
Ficus palmata
Ficus pandurata
Ficus pantoniana— Climbing Fig
Ficus panurensis
Ficus pertusa
Ficus petiolaris (= F. palmeri)
Ficus pilosa
Ficus piresiana Vdzq.Avila & C.C.Berg
Ficus platypoda— Desert Fig, Rock Fig
Ficus pleurocarpa— Banana Fig, Gobi Fig, Karpe Fig
Ficus polita Vahl
Ficus polita ssp. polita
Ficus prolixa G.Forst. (= F. mariannensis Merr.)
Ficus pseudopalma Blanco
Ficus pulchella
Ficus pumila— Creeping Fig
Ficus pumila var. awkeotsang
Ficus pyriformis
Ficus racemosa— Cluster Fig, Goolar Fig, udumbara (Sanskrit), umbar (India) Ficus ramiflora
Ficus religiosa— Sacred Fig, arali, bo, pipal, pippala, pimpal (etc.), pou (Cambodia), Ashvastha
Ficus retusa— Taiwan Fig, Ginseng Fig, "Indian laurel", "Cuban-laurel"
Ficus rieberiana C.C.Berg
Ficus roraimensis Ficus roxburghii
Ficus rubiginosa— Port Jackson Fig, Little-leaved Fig, Rusty Fig, damun (Sydney Language)
Ficus rumphii Blume— Rumpfs Fig
Ficus salicifolia Vahl (= F. pretoriae Burtt Davy)— Willow-leaved Fig
Ficus salzmanniana
Ficus sansibarica Warb.
Ficus sarmentosa
Ficus saussureana
Ficus scabra G.Forst.
Ficus schippii
Ficus schultesii
Ficus schumacheri
Ficus septica Burm. F. var. septica Moraceae— Hauli Tree in Philippines Ficus sphenophylla
Ficus stahlii
Ficus stuhlmannii Warb.
Ficus subpuberula
Ficus superba
Ficus superba var. henneana
Ficus sur Forssk. (= F. capensis)
Ficus sycomorus— Sycamore Fig, Fig-mulberry
Ficus sycomorus ssp. sycomorus
Ficus sycomorus ssp. gnaphalocarpa (Miq.) C. C. Berg
Ficus tettensis Hutch. (= F. smutsii Verdoorn)
Ficus thonningii
Ficus tinctoria— Dye Fig, Humped Fig
Ficus tobagensis
Ficus tomentella
Ficus tomentosa
Ficus tonduzii Standi.
Ficus tremula Warb.
Ficus tremula ssp. tremula
Ficus triangularis
Ficus trichopoda Bak. (= F. hippopotami Gerstn.)
Ficus trigona L.f.
Ficus trigonata
Ficus triradiata— Red-stipule Fig
Ficus ulmifolia
Ficus umbellata
Ficus ursina
Ficus variegata Bl.
Ficus variegata var. chlorocarpa King
Ficus variolosa
Ficus velutina
Ficus verruculosa Warb.
Ficus virens— White Fig, pilkhan, an-borndi (Gun-djeihmi)
Ficus virens var. sublanceolata White Fig, New South Wales
Ficus virgata Ficus wassa
Ficus watkinsiana— Watkins' Fig, Nipple Fig, Green-leaved Moreton Bay Fig
Ficus yoponensis Desv.
4. The composition of claim 1, wherein said fig plant material is obtained from Ficus afghanistanica.
5. The composition of claim 2, wherein said fig leaves are obtained from Ficus afghanistanica.
6. The composition of any of claims 1 to 5, wherein said extract is a liquid extract.
7. The composition of claim 6, wherein said liquid extract is aqueous liquid extract.
8. The composition of any of claims 1 to 5, wherein said composition is in the form of liquid tea, beverage, tincture, ampoule, gel and/or syrup.
9. The composition of any of claims 1 to 5, wherein said extract is a solid extract.
10. The composition of any of claims 1 to 5, wherein said composition is in the form of dry tea, capsule, pill and/or tablet.
11. A composition comprising an extract of fig plant material according to any of claims 1 to 10 for use in a method for preventing and/or treating benign prostatic hyperplasia and/or symptoms of benign prostatic hyperplasia.
12. The composition of claim 11, wherein said extract of fig plant material is aqueous liquid extract of fig leaves obtained from Ficus afghanistanica.
PCT/IB2011/053951 2010-09-10 2011-09-09 Composition comprising a fig plant material extract and use thereof in the treatment of benign prostatic hyperplasia WO2012032494A1 (en)

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CN102631442A (en) * 2012-03-31 2012-08-15 北京绿源求证科技发展有限责任公司 Traditional Chinese medicine (TCM) for treating prostatic hyperplasia
WO2014088520A1 (en) * 2012-12-03 2014-06-12 Eraslan Mustafa Usage of fig fruit extract and olive leaf extract combinations together with green tea and grape seed extracts
CN103893188A (en) * 2014-04-11 2014-07-02 扬州大学 Application of ilexgenin A in preparation of anti-tumor medicaments
WO2020076051A1 (en) * 2018-10-08 2020-04-16 한국생명공학연구원 Composition for alleviating symptoms of andropause, containing extract of ficus auriculata lour. as active ingredient

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102631442A (en) * 2012-03-31 2012-08-15 北京绿源求证科技发展有限责任公司 Traditional Chinese medicine (TCM) for treating prostatic hyperplasia
WO2014088520A1 (en) * 2012-12-03 2014-06-12 Eraslan Mustafa Usage of fig fruit extract and olive leaf extract combinations together with green tea and grape seed extracts
CN103893188A (en) * 2014-04-11 2014-07-02 扬州大学 Application of ilexgenin A in preparation of anti-tumor medicaments
WO2020076051A1 (en) * 2018-10-08 2020-04-16 한국생명공학연구원 Composition for alleviating symptoms of andropause, containing extract of ficus auriculata lour. as active ingredient
KR20200040007A (en) 2018-10-08 2020-04-17 한국생명공학연구원 Composition for improving andropause syndrom comprising Ficus auriculata Lour. extract as an active ingredient
KR102202711B1 (en) * 2018-10-08 2021-01-12 한국생명공학연구원 Composition for improving andropause syndrom comprising Ficus auriculata Lour. extract as an active ingredient
CN112823016A (en) * 2018-10-08 2021-05-18 韩国生命工学研究院 Composition for improving male climacteric symptoms containing Ficus auriculata extract as effective component
US20220265753A1 (en) * 2018-10-08 2022-08-25 Korea Research Institute Of Bioscience And Biotechnology Composition for alleviating symptoms of andropause, containing extract of ficus auriculata lour. as active ingredient

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