GB2388539A

GB2388539A - Herbal formulations

Info

Publication number: GB2388539A
Application number: GB0211145A
Authority: GB
Inventors: Nandkishore Bapurao Managoli
Original assignee: Sahajanand Biotech Pvt Ltd
Current assignee: Sahajanand Biotech Pvt Ltd
Priority date: 2002-05-15
Filing date: 2002-05-15
Publication date: 2003-11-19
Also published as: AU2003230085A1; WO2003097076A1; GB0211145D0

Abstract

Two new polyherbal formulations are described and which, when used together, have been found to be effective for the treatment of cancer and, more particularly, for the treatment or management of adenocarcinoma of the prostate. The first formulation comprises a mixture of the following six herbs: Glycine max, Lycopersicon esculentum, Allium sativum, Curcuma longa, Linum usitatissimum and Convolvulus arvensis; or a mixture of the active ingredients that have been extracted from those herbs or chemically synthesised. The second formulation comprises a mixture of the following four herbs: Tinospora cordifolia, Withania somnifera, Phyllanthus emblica and Asparagus racemosus; or a mixture of active ingredients that have been extracted from those herbs or chemically synthesised.

Description

HERBAL FORMULATIONS

This invention relates to two new polyherbal formulations which, when used 5 together, have been found to be effective for the treatment of cancer. More particularly, they can be used to treat or manage adenocarcinoma of the prostate. The prostate is uniquely a male organ. Carcinoma of the prostate gland is lo predominantly a tumor of older men, androgen-dependent, which frequently responds to therapy even when widespread and may be cured when localized. The rate of tumor growth varies from very slow to moderately rapid, and some patients have prolonged survival even after the cancer has metastasized to distant locations, especially to the bone.

Is The currently available conventional modes of therapy include: surgery, radiation therapy, chemotherapy, and hormonal therapy. The drugs given during chemotherapy are of necessity very powerful and, in consequence, can have serious and undesirable side-effects. There is therefore a need to for improved pharmaceutical or medicinal preparations for use in the treatment of cancer. It is the object of this invention to provide such a product. The present invention is based on adopting a holistic approach towards the 25 malignancy rather than the "pin-pointed" highly targeted approach of conventional therapy. Holistic treatment of cancer involves a broad-based, multi-pronged attack that would include: a) cytotoxic, antimitotic and antineoplastic effects of the therapy, to b) enhancing the immune status of the subject through immunostimulation and adaptogenic effects,

- ( c) equipping the patient with antioxidants, d) depriving the neoplasm of hormones required for its growth, e) causing apoptosis of the tumor cells, thereby inhibiting the cell cycle and tumor growth, 5 stabilizing the cell membrane and basement membrane so that metastasis can be prevented, 9) improving the nutritional and psychological status, thereby improving patient compliance to therapy, and h) causing inhibition of angiogenesis, thereby starving the tumors of 10 their iife-blood.

The herbs included in the formulation of this invention are widely available in nature and have been carefully chosen to ensure optimum therapeutic results as listed above, and at the same time to ensure that each Is formulation is devoid of adverse toxic reactions. Most of the herbs have been in use in India and in other countries for many years, even for centuries, as culinary ingredients and in traditional medicines, which also proves the lack of toxicity of the component herbs. The acute animal toxicity studies conducted using the formulations of this invention have ho shown no toxicity at the prescribed dosage.

According to the present invention there is provided a pharmaceutical or medicinal preparation which comprise a mixture of the following six herbs: Glycine max. Lycopersicon esculentum, Allium sativum, Curcuma longs, 25 Linum usitatissimum and Convolvulus arvensis; or a mixture of the active ingredients that have been extracted from those herbs or chemically synthesized. This preparation is referred to hereafter as the 'iprincipal anticancer therapy" formulation. It is preferably formulated for administration to patients as a liquid or syrup, but could also be so administered as a capsule or tablet.

According to the present invention there is also provided a pharmaceutical or medicinal preparation which comprises a mixture of the following four herbs: Tinospora cordifolia, Withania somnifera, Phyllanthus emblica and Asparagus racemosus; or a mixture of active ingredients that have been 5 extracted from those herbs or chemically synthesized. This preparation is referred to hereafter as the "supportive therapy" formulation. It is preferably formulated for administration to patients as a liquid or syrup, but could also be administered as a capsule or tablet.

lo According to a further embodiment of the present invention there is provided a pack or other product which comprises both a quantity of the said principal anticancer therapy formulation and quantity of the said supportive therapy formulation. The pack or other product may also include instructions regarding the administration of these two formulations 15 to patients.

The present invention is based on the surprising discovery that, when used in combination, these two polyherbal formulations provide an effective method of therapy for cancer. More particularly, they can be used to treat so or manage adenocarcinoma of the prostate. The therapy is both specific and cost effective.

The two formulations are intended to be used together as therapeutic complements so as to attain optimum therapeutic effects in the 25 management of various aspects of adenocarcinoma of the prostate. They provide an approach towards treating such patients that is broad-based or holistic as against the targeted approach of the conventional modes of therapy. The intent of the therapy is to achieve therapeutic cure, and, in addition, address the problems associated with all malignancies in general so (for example, improvement in quality of life, etc.) and the problems associated with adenocarcinoma of the prostate in particular (for example,

( prevention of metastasis, etc). While the two formulations are preferably administered simultaneously to patients, it will be appreciated that they may be given in succession and that a short interval of time between each of them being ingested would not diminish the effectiveness of the therapy.

The combination of herbs used and the proportion in which each of them is used are extremely important to achieve the claimed effects and to minimize or eliminate the adverse reactions, if any, during the course of therapy. Therefore, the herbs have been strategically chosen to cover all lo the known aspects of antineoplastic therapy as well as to eliminate the side effects, thereby creating a novel therapy for the management of adenocarcinoma of the prostate.

The ingredients for typical herbal formulations according to this invention 15 are set out in Table I (principal anticancer therapy formulation) and Table II (supportive therapy formulation). It should be appreciated that the proportions of the individual herbs may be varied and the figures quoted in Table I and Table II are by way of illustration only. In particular, the proportions of one or more of the components may be varied in order to to optimise the pharmacological effects produced by the formulation to suit the specific needs of patients being treated.

The reason for separating the therapeutic regimen into two components is mainly due to the fact that they are each designated different roles in the 25 management of adenocarcinoma of the prostate, namely Formulation #1 is responsible for the antitumor effects in particular; while Formulation #2 acts as its therapeutic complement and serves to improve the immunity, the psychological status and the other "quality of life" parameters of the patient, rather than itself having any direct antitumor effect. It is important to note so that the two formulations are designed to work in tandem as therapeutic complements to obtain optimum therapeutic efficacy and which would not

be attainable if either of them is used alone.

The composition of the two formulations is unique, and is not known for use in medicine, especially the specificity of, and the choice of herbs used, and also the concentration of the individual herbs and the process of extraction used, all of which contribute to the uniqueness of the formulations and are responsible for their unmatched efficacy in the management of adenocarcinoma of the prostate. It is possible that some of the herbs are already being used for treating other diseases, or even for treating lo adenocarcinoma of the prostate. It must therefore be understood that the uniqueness of the therapy of the present invention lies in the combination of the 10 herbs specified, in the concentration in which each of them is used, the method of extraction, and the "holistic" approach to their use in the management of adenocarcinoma.

The 10 herbs cannot simply be included together in a single preparation because each of the capsules used would contain 500 mg of the herbal extracts of Formulation #1 and Formulation #2 respectively, and it would be impossible to achieve the desired therapeutic effects when combined in a so single preparation. Inclusion of all the 10 herbs in one preparation would lead to a physical reduction in the quantity of the active ingredients of each of the herbs used in each of the capsules, subsequently leading to their reduced blood levels in the patients, resulting in suboptimum therapeutic results. It is an important feature of the product of the present invention that it contains a mixture of herbs, or extracts from herbs, rather than being based on a single herb. A synergistic effect has been noticed between the various ingredients. The activities of similar herbs are combined to so optimise and enhance the pharmacological effects without increasing the adverse toxic reactions (which becomes a distinct possibility if the herbs

are used singly in a concentration of 100%). The advantage of a multidrug regimen also lies in the fact that the possibility of development of drug resistance is minimised.

5 Preliminary clinical trials of the formulations of this invention have produced evidence that they can be used effectively for: 1. Treatment and cure of patients diagnosed as suffering from adenocarcinoma of the prostate, irrespective of the clinical stage, lo histological grade, or whether the tumor is hormone-responsive or hormone-unresponsive. 2. Prevention of metastasis in patients diagnosed as suffering from adenocarcinoma of the prostate.

3. Prevention of relapse in a patient diagnosed as, and treated for, adenocarcinoma of the prostate, by conventional radiotherapy, chemotherapy, hormonal therapy or surgical therapy.

JO 4. Prevention of the primary occurrence of adenocarcinoma of the prostate in persons who are genetically predisposed to the disease, as evidenced by a family history of the disease.

5. Improving the response to conventional chemotherapy or 25 radiotherapy in a patient diagnosed as suffering from adenocarcinoma of the prostate and undergoing either of the above-mentioned conventional therapies. 6. Improving the 'quality of life'parameters of patients diagnosed as So suffering from adenocarcinoma of the prostate. These parameters include:

[a] improvement in appetite, [b] increase in body weight, 1c] improvement in ambulation, [d] improvement in bowel habits, 5 [e] improvement in psychological status, [f] improvement in the ECOG performance status, and [9] other subjective improvements as experienced by such patients.

7. Improving the immune status of patients diagnosed as suffering from lo adenocarcinoma of the prostate so that such immunocompromised patients become immunocompetent, and to enable them in combating the superinfections associated with such immunocompromised states.

8. Improving the adaptogenic potential of patients diagnosed as suffering Is from adenocarcinoma of the prostate so that: [a] the various cytotoxic therapies cause no harm and place no further stress on the body, [b] help the body adapt to many and varied environmental and to psychological stresses, and [c] there is regulation of, and support to, all the major systems of the body, such as the nervous system, the hormonal system, the immune system, as well as regulation of the biochemical functions like blood sugar, etc. 9. Increasing the survival rates in patients diagnosed as suffering from adenocarcinoma of the prostate, and also in patients who are disease-free through the actions of the antioxidants and anti- ageing components of the formulation.

30 D

The manufacture of a product according to the present invention will now

( be illustrated by the following example. However, it will be appreciated that the active ingredients may be chemically synthesised as an alternative to being extracted from the natural herbs.

s EXAMPLE

Method of Extraction Each of the herbal components of the formulation were de-seeded to (wherever required), ground finely to powder form and then submitted individually to cold extraction by using volatile freon gas. This process has the advantage of being fast and also has the ability to preserve the active chemicals (alkaloids, non-alkaloids, electrolytes, minerals, etc.) in their natural form (as it does not involve heating and denaturation at any stage 15 of the process). Freon, being a highly volatile compound with its boiling point at -21 C, evaporates totally after extraction, yielding an ultrapure concentrate of the chemicals. The chemicals were thereafter diluted appropriately and mixed in the proportions mentioned in Table l/Table 11.

20 Preliminary Clinical Data An elderly male patient aged 74 years had complained of urinary outflow obstruction and low backache for some year. Urological examination revealed an enlargement of the prostate. Serum PSA levels were markedly as elevated [103 ng/ml] and MRI showed metastasis in the spine. Subsequent biopsy confirmed adenocarcinoma of the prostate.

The patient began taking the herbal formulations of the present invention in January 2002. Monthly PSA levels fell steadily and the most recent so estimation showed a level of just 12 ng/ml [April 2002]. There is a marked improvement in the quality of the life of the patient, such as increased

appetite, improved ambulation, etc. In addition to these therapeutic results, the treatment has had no adverse effects on the patient whatsoever since initiating therapy.

5 These results demonstrate that the combination therapy of the present invention has a very beneficial effect on patients suffering from adenocarcinoma of the prostate.

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Claims

r. r CLAIMS

1. A pharmaceutical or medicinal preparation which comprises a mixture of the following six herbs: Glycine max. Lycopersicon s esculentum, Allium sativum, Curcuma longs, Linum uUsitatissimum and Convolvulus arvensis; or a mixture of the active ingredients that have been extracted from those herbs or chemically synthesized.

lo

2. A pharmaceutical or medicinal preparation which comprises a mixture of the following four herbs: Tinospora cordifolia, Withania somnifera, Phyllanthus emblica and Asparagus racemosus; or a mixture of active ingredients that have been extracted from those herbs or chemically synthesised.

3. A pack or other product which includes a preparation according to claim 1 together with a preparation according to claim 2.

4. A preparation as claimed in claim 1 or claim 2, or a pack or other 20 product as claimed in claim 3, for use in the treatment of cancer.

5. A preparation as claimed in claim 1 or claim 2, or a pack or other product as claimed in claim 3, for use in the treatment of adenocarcinoma of the prostate.

6. A product containing a preparation according to claim 1 and a preparation according to claim 2, as a combined preparation for simultaneous, separate or sequential use in the treatment of cancer.