GB2355189A

GB2355189A - Herbal preparation

Info

Publication number: GB2355189A
Application number: GB9919811A
Authority: GB
Inventors: Yousef Haik Babikian
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-08-20
Filing date: 1999-08-20
Publication date: 2001-04-18
Anticipated expiration: 2019-08-20
Also published as: GB9919811D0; GB2355189B

Abstract

A composition comprising Coriandum Sativum; lavender, Pelargonium Graveolens or basil (Ocimum Basilicum and/or Ocimum Kilimand) or any mixture thereof; rosemary; Nigella Sativa; Lepidium Sativum; and Commiphora Myrrh any may include the leaves, seeds, roots, flowers or oil of the above. The composition may be formulated as a pharmaceutical for the treatment of the following : diabetes mellitus, serum cholesterol disorder, serum triglycerides disorder, uric acid disorder, primary or essential hypertension, nervousness, stress fatigue, or in supporting the immune system.

Description

2355189 Herbal Preparation for the Treatment of Diabetes Mellitus; The

present invention relates to a novel composition and its use in the treatment of diabetes mellitus. More particularly, it relates to a composition prepared from naturally occurring plants and/or their oils. The composition is also effective in the treatment of serum cholesterol disorder, serum triglycerides disorder, uric acid disorder, primary or essential hypertension, in the treatment of nervousness, stress and fatigue conditions and in supporting the immune system of the patient.

Diabetes is a condition that occurs because of a lack of insulin or because of the presence of factors opposing the action of insulin. The result of insufficient action of insulin is an increase in blood glucose (hyperglycaemia). Many other metabolic abnormalities occur, notably an increase in ketone bodies in the blood when there is a severe lack of insulin.

Insulin is the major hormone secreted by the pancreas. It is a small protein comprising 51 amino acid residues and is synthesised in the beta cells of the Islets of Langerhands via its precursor, proinsulin. One molecule of proinsulin is cleaved by enzymes to give one molecule of insulin and one molecule of C-peptide (which is physiologically inert).

C-peptide can be measured in some diabetic patients to show that insulin production has occurred.

Insulin acts in several ways to reduce circulating blood glucose levels. It enhances cellular uptake of glucose from the blood in many tissues, particularly skeletal muscle and adipose tissue. It also stimulates glycogen production and inhibits glycogen breakdown in muscles and hepatocytes.

Patients suffering from diabetes can show a wide range of symptoms such as, excessive thirst and appetite (polydypsia), excessive urination (polyuria), pruritus or balanitis, weight loss, lethargy, nausea, bluffed vision. In women, frequent vaginal infection e.g.Candida 2 infection can occur. Diabetic men may suffer from impotence.

The World Health Organisation recognises five categories of diabetes. In addition there is a sixth condition. 5 1. Type one diabetes mellitus occurs in about 20% of all diabetic patients. This is characterised by insulin deficiency resulting from immune-mediated pancreatic beta-cell destruction. Type I diabetes results from the destruction of the pancreatic beta-cells, through an autoimmune process of unknown aetiology, leading to insulin deficiency and associated. ketoacidosis. Pancreatic beta-cell destruction eventually results in absolute insulin deficiency. The pathological process occurs in genetically predisposed individuals over many years and appears to be triggered by environmental factors such as viral infections and nutritional factors such as ingestion of cows milk in early childhood.

2. This type of diabetes mellitus occurs in about 75 % of all diabetic patients. It is generally characterised by peripheral insulin resistance and relative insulin deficiency which may range from predominant insulin secretory defect with insulin resistance.

Some patients develop severe insulin deficiency. Obesity is common in patients with type 2 diabetes and itself causes insulin resistance. Peripheral plasma insulin levels are usually high with relative insulin deficiency being characterised by a delayed initial first phase insulin response with second phase insulin response being weakened over several years. Resistance to the action of insulin takes the form of a decrease in the ability of skeletal muscle to store glucose (due to a reduction in activity of the enzyme glycogen synthase) and oxidise glucose (due to a reduction in pyruvate dehydrogenase activity).

The risk of developing type 2 diabetes increases with age, obesity (particularly central obesity), family history of diabetes or cardiovascular disease (particularly hypertension or dyslipidaemia), and a lack of physical activity.

3 3. Malnutrition related diabetes mellitus (MRDM). 4. Diabetes associated with other conditions and syndromes such as pancreatic disease, disease of hormonal aetiology, drug-induced or chemical-induced diabetes, 5 abnormalities of insulin or its receptors, certain genetic syndromes and miscellaneous syndromes. 5. Gestational diabetes.

6. Impaired Glucose Tolerance (IGT).

The invention is based on combining certain well-known plants, and/or their oils. It has been, found through intensive efforts that this combination is effective in reconstitution of the cells of the pancreas and able to treat and manage the diabetes mellitus as well as other diseases.

The plants are:

1. Coriandrum Sativum: family Apiacea) Leaves, seeds, roots and/or the oil.

2. Lavender: family Lamiaceae) Leaves, seeds, roots, flowers and/or the oil.

3. Pelargonium Graveolens: (Family Geraniaceae) Leaves, seeds, roots and flowers and/or the oil, or Basil (Ocirnum. basilicum. and Ocimum kilimand). Family Labiatae.

4. Rosemary: (Family Labiatae) Leaves, seeds, roots and flower, and/or the oil.

5. Negella Sativa: Leaves, seeds, roots and flowers and/or the oil.

6. Lepidiurn Sativum: Leaves, seeds, and flower, and/or the oil.

7. Comn-Aphora Myrrh.

In a first aspect of the invention, there is provided a composition comprising Coriandum Sativurn; lavender, Pelargonium. Graveolens or basil (Ocimum Basilicurn and/or Ocimum Kilimand) or any mixture thereof; rosemary; Negella Sativa; Lepidium Sativum; and 4 Commiphora Myrrh. Preferably, the composition comprises both lavender and any one of Pelargonium Graveolens or basil (Ocimum Basilicurn and/or Ocirnum, Kilimand).

In a preferred embodiment, the components of the composition are present in the following 5 percentages:

Component Preferred Especially Preferred Coriander Sativurn 30-50% About 40% Lavender or Pelargoniurn 10-50% About 20 % Graveolens or Basil (or any mixture thereof) Rosemary 5-20% About 10% Negella Sativa 5-30% About 15 % Lepidium Sativurn 5-15% About 7.5 % Commiphora Myrrha 5-15% 7.5% The composition may be combined with a pharmaceutically acceptable vehicle, carrier or 10 diluent.

In a second aspect of the invention, there is provided a composition as defined above for use in a method of treatment of the human or animal body by surgery, therapy or diagnosis.

In a third aspect of the invention, there is provided the use of a composition as defined above in the manufacture of a medicament for treatment of diabetes mellitus; serum cholesterol disorder; serum triglycerides disorder; uric acid disorder; primary or essential hypertension; in the treatment of nervousness, stress and fatigue conditions; or in supporting the immune system of the patient.

In a fourth aspect of the present invention, there is provided a method for the treatment of the disorders and diseases defined above, comprising administering to the patient a pharmaceutically effective dose of the above-defined composition.

The composition may be in herbal (dry) form in which case a suggested dosage is from 5 to 15g twice daily orally with water. Alternatively, it may be administered as an oil extraction, in which case from 0.3 to 0.7ml is taken sublingually or in capsule form twice daily. A herbal extract of from 10 to 20ml may be taken orally 2 to 3 times daily. Alternatively from 0. 1 to 0.5n-A may be injected intramuscularly once a day.

Ex4Mple I - Prpparation of herbal mixture The herbal mixed form of the preparation is prepared by mixing the dried leaves, seeds, root, and flowers of the plants in the following percentages:

1. Corianderum Sativum 40% seeds.

2. Lavender 10% leaves, flowers and roots.

3. Pelargonium Graveolens 10% leaves, flowers, and roots.

or its substitute the plant Basil, the Ocimurn basilicum and Ocimum kilimand - scharicum.

4. Rosemary 10% leaves and flowers.

5. Negella Sativa 15% seeds 6. Lepidium Sativurn 7.5% seed.

7. Commiphora Myrrh 7.5% seeds The branches leaves, flowers and roots of each plant separately, were collected, cleaned and chopped into pieces from about I to 2 cm in length, then the material were dried under approximately 25 to 35 degrees Celsius in dark, dried and ventilated conditions. The dried 6 material was crushed almost into powder form. The seeds were also cleaned and crushed almost into powder form.

The mixture of the crushed materials was milled together according to the required percentages using a stainless steel electrical mixer for 10 to 15 minutes. Then the mixture was sterilised and packed.

The herbal mixture form of the invention is ready at this stage and can be filled in packets of 50,100,200, 300 grams etc. It can be provided in any suitable form, for example "teabag" 10 form, tablet form etc.

Exgmple 2 - Oil blend formula The oils used in this formula are prepared as 100% pure essential oils by steam distillation of 15 the plant material at low pressure.

One kg of the blend formula was prepared by blending the seven oils together using a glass or high quality stainless steel blender. The percentage and the sequence relations of the oils are the same as in Example 1. 20 ExMle 3 - Herbal extract The extract form of the invention was prepared by mixing the already prepared water extractions of the plants, Corianderum. Sativurn, Lavender, Pelargonium Graveolens or (Basil), 25 Rosemary, Negella Sativa, Lepidium Sativurn and Commiphora Myrrh.

A, Preparation of the extract of Coriandrum. Sativum (Seeds) In order to prepare one litre of the extract; 1. 250 grams of the Coriander seeds were washed thoroughly with distilled water then 7 sterilised.

2. One litre of Pyrogen-free distilled water poured into large beaker or any stainless steel container that was previously cleaned and washed by pyrogen-free distilled water and sterilised in an oven at 125'C for one hour.

3. The water was heated up and kept at 35 degrees Celsius on an electrical cooker equipped with accurate thermostat.

4. The 250 gram of seeds were added to the water and kept at that temperature (35 degrees Celsius) for 12 hours and stirred every one hour using a glass stirrer.

5. The contents of the beaker were processed through a coarse filter and then through a medical filter and decanted into 1000ml bottle with tight lid.

In order to prepare an extract for use in injection form, the oral form of the extract was subject to filtration using medical filter paper with porosity from about 2.5 microns to about 4.5 microns.

6. The extract was allowed to remain at room temperature for approximately 5 hours after which the extract was kept in the refrigerator at 2 to 4 degrees Celsius.

B. Preparing one litre extract from the seeds of the Negell Sativa. The same procedure as above was followed.

C. Preparing one litre extract from the seeds of the Laidium Sativurn. The same mentioned procedure was followed.

D. Preparing one litre of extract from the seeds of the Commiphora Myrrh. The same procedure as above was followed.

E. Preparing one litre extract from the leaves and branches of the Rosemary, In the following procedure:

100gm. of the fresh branches, leaves, flowers, and roots of the plant were collected, cleaned and chopped into pieces from about 1 to 2 cm in length.

8 One litre of Pyrogen-free distilled water was poured into large beaker or any Pyrex-glass or stainless steel container that was previously cleaned and washed by pyrogen free distilled water and sterilised in an oven at 125'C for one hour.

The water was heated up and kept at 35 degree Celsius on an electrical cooker equipped with accurate thermostat.

The 100 grams of the plant material was added to the water and kept at that temperature for 12 hours and stirred every hour using a glass stirrer. After that the extract was allowed to stay at the room temperature for about one hour. The contents of the beaker were processed through a coarse fitter and then through a medical filter and decanted into 100ml bottle with tight lid.

The extract was allowed to remain at room temperature for approximately 5 hours after which the extract was kept in the refrigerator at 2 to 4 degrees Celsius.

The extract can be used for mixing with other extracts after taking it out from the refrigerator and keeping at the room temperature for 5 hours.

F. A one litre extract from the Pelargoniurn GrUeolons, leaves and flowers was prepared by following the same procedure as in E above.

G. A one litre extract from the leaves and flowers of Lavender was prepared by following the same procedures as in E above.

H. The extracts were mixed together using an electrical stainless steel mixer by adding each extract according to the percentage required.

9 1 At first, the Corianderum sativurn extract was put in the mixer, then followed by the Lavender extract, the Pelargonium graveolens; the Rosemary, the Negella sativa, the Lepidiurn sativurn and the Myrrh commiphora extracts, subsequently allowing 10 to 15 minutes mixing time interval between the addition of each new extract.

J. The mixture was also mixed in the mixer for another 20 minutes. After that the mixture was allowed to stay in the room temperature for about 5 hours.

K. The preparation was dispensed into 100ml medical dark brown bottles and after sterilisation the bottles were kept in the refrigerator at 2 to 4 degrees Celsius.

Dosage and administration The preparation is indicated as an effective treatment and prophylactic therapy against all types of diabetes mellitus, Hypercholesterolaemia, Hypertriglycridaemia, Hyperuricaemia, essential hypertension and as immune modulator agent able to induce the body's own defence 15 mechanisms in a non-specific or even specific manner. The effect of the immunostimulants may be direct or indirect, via the complementary system or the lymphocytes.

According to the experimental results a 3 to 6 month course is sufficient to treat diabetes mellitus, while after one month of using the therapy the complication of the disease will be 20 eliminated. For diabetes associated with the conditions and syndromes, the duration of taking the preparation depends on the severity of the disease. However, even in terminal cases with serious complications, the patients had a good life style.

Suggested intake:

1. Herbal mixture 10 gm twice daily (orally) with water.

2. Oil mix 0.5ml twice daily sublingually. Or in capsules.

3. Herbal extract to 20ml, 2 to 3 times daily (orally). The injection form is 0.3ml I.M. once daily to an average 70kg body weight.

ExMle 4 - Animal eUeriments The preparation was tested on Australian rabbits of the weight specified in the Tables below (measured in grams). The rabbits were given a high concentration glucose IN. and blood samples were taken (this was taken as zero time). A dosage of the extract prepared in Example 3 was given to each animal S.C. and blood samples were taken at 1, 4, 6 and 24 hours. The blood glucose levels were measured (in mg/dl) and the results are shown in Tables 1 to 3 below:

Table I - GroMp I Dosage 0.2ml/k Animal No. Weight Initial lhr Time 4hr Time 6hr Time 24hr Time Glucose Glucose Glucose Glucose Glucose 1 275 316 300 190 95 81 2 275 320 315 175 105 76 3 280 260 260 136 92 84 4 270 290 270 148 108 74 Table 2 - Grogp 11 Dosage 0.4ml/k Animal No. Weight 0 Time lhr Time 4hr Time 6hr Time 8hr Time 24hr Time Glucose Glucose Glucose Glucose Glucose Glucose 1 295g 370 350 190 118 89 81 2 270g 360 310 179 126 76 83 3 298g 318 240 128 94 84 80 4 280 408 305 214 136 94 75 I I Table 3 - GroLip III Dosage 0.6ml/kg Animal No. Weight 0 Time I hr Time 4hr Time 6hr Time 8hr Time 24hr Time Glucose Glucose Glucose Glucose Glucose Glucose 1 291 360 160 90 76 71 78 2 298 290 116 80 67 60 50 3 230 285 115 66 45 Died - 4 260 295 105 60 43 48 ExqMple 5 - Animal eUeriments The oil formula prepared in Example 2 was also given to animals using the same procedure as in Example 4. The blood glucose levels (measured in mg/dl) are shown in Tables 4 and 5 below:

Table 4 - GroMp 1 Dose Used 0.4ml/kg Animal No. Weight 0 Time I hr Time 4hr Time 6hr Time 24hr Time Glucose Glucose Glucose Glucose Glucose 1 329 154 167 118 80 98 2 278 358 327 210 81 91 3 315 346 181 57 20 Died Average 307 286 225 126.3 60.3 94.5 12 Table 5 - Group 2 Dosc Used 0.2ml/kg Animal No. Weight 0 Time 1 hr Time 4hr Time 6hr Time 24hr Time Glucose Glucose Glucose Glucose Glucose 1 340 122 102 65 171 99 2 371 251 136 106 170 102 3 372 268 131 87 92 94 4 388 175 145 128 148 93 Average 204 128.5 96.5 145.2 97 Example 6 - Clinical trials The preparation was administered to more than 100 volunteers that had diabetes mellitus in different ages and stages. The fasting blood sugar (FBS) and the glycocylated Hb, (Hb AIC) was tested before and after the administration of the preparation. Depending on the severity of the cases, in 3 months up to 6 months of treatment both the FB S and the Hb A 1 C returned to normal ranges gradually. Patients started to reduce their insulin intake accordingly by the advice of their Doctors due to the significant improvement in their cases until the medication was not needed any longer. All patients from 2 weeks after the beginning of the treatment started to feel good, active, and have fewer urination intervals.

The results for four individual patients are shown in Tables 6 to 9 below. In the tables:

FBS is measured in mg/dl. The normal reference range is 74-110 mg/dl.

HBAlC is measured by percentage and the normal reference range is 4.2-6. 2%. FBS pp is measured in mg/dl and the normal reference range is less than 140 mg/dl. Insulin is measured in mcU/ml and the normal reference range is 5-20mcU/ml. Cholestrol (total) is measured in mg/dl and the normal reference range is up to 200 mg/dl.

13 Table 6

Test Initial 1 month 2 months 3 months 4 months 5 months FBS 280 220 120 120 115 108 Hb AIC 9.8 9 8.4 7.6 6.7 5.9 Insulin 10 10 10 10 10 10 fasting FBS pp 390 380 225 220 180 172 Insulin pp 30 35 55 59 71 72 Table 7

Test Initial I month 2 months 3 months 4 months 5 months FBS 300 220 133 120 110 101 Hb AIC 10 9.3 8.1 7.6 6.4 5.7 Insulin 46 23 22 22 22 20 fasting FBS pp 537 378 220 186 180 185 Table 8

Test Initial 1 month 2 months 3 months 4 months 5 months 6 months FBS 530 424 338 270 216 151 121 Hb AlC 16 14.4 10.2 9.6 9 7.7 6.2 Table 9

Test Initial I month 2 months 3 months 4 months 5 months 6 months FBS 152 148 137 135 120 106 80 Hb AlC 8.2 8 7.8 7.4 6.5 6.67 6.2 2hrs pp 213 208 198 160 172 160 148 blood sugar Cholestrol 231 218 194 155 150 155 148 (total) 14

Claims

1. A composition comprising Coriandurn Sativum; lavender, Pelargonium Graveolens or basil (Ocimum Basilicum and/or Ocirnurn Kilimand) or any mixture thereof; rosemary; Negella 5 Sativa; Lepidium. Sativurn; and Commiphora Myrrh.

2. A composition as claimed in claim 1, which comprises both lavender and any one of Pelargonium. Graveolens or basil (Ocimurn Basilicurn and/or Ocimurn Kilimand).

3. A composition as claimed in claim I or 2, wherein the amount of Coriander Sativurn is from 30 to 50 %, preferably about 40

4. A composition as claimed in any preceding claim, wherein the amount of lavender, Pelargonium. Graveolens or basil (Ocirnurn Basilicurn and/or Ocirnum. Kilimand) or any mixture thereof is from 10 to 50%, preferably about 20%.

5. A composition as claimed in any preceding claim, wherein the amount of rosemary is from 5 to 20%, preferably about 10%.

6. A composition as claimed in any preceding claim, wherein the amount of Negella Sativa is from 5 to 30 %, preferably about 15 %.

7. A composition as claimed in any preceding claim, wherein the amount of Lepidium Sativurn is from 5 to 15 %, preferably about 7.5 25

8. A composition as claimed in any preceding claim, wherein the amount of Commiphora Myrrha is from 5 to 15 %, preferably about 7.5 %.

9. A composition as claimed in any preceding claim in combination with a pharmaceutically 30 acceptable vehicle, carrier or diluent.

10. A composition as claimed in any preceding claim for use in a method of treatment of the human or animal body by surgery, therapy or diagnosis.

11. The use of a composition as claimed in any preceding claim in the manufacture of a medicament for treatment of diabetes mellitus; serum cholesterol disorder; serum triglycerides disorder; uric acid disorder; primary or essential hypertension; in the treatment of nervousness, stress and fatigue conditions; or in supporting the immune system of the patient.