w.s.r. to Diabetes Mellitus A Critical study of Pramehahara effect of Dhaatri Nishe w.s.r. to Diabetes mellitus

Nishaamlaki is a known Ayurvedic medicinal preparation which is found effective in controlling the Diabetes mellitus. But according to Astanga hridaya “ Meheshudhaatrinishe ” combination of Aamlaki and two Haridra drugs effectively controls Prameha .Here the word “ NISHE ” indicates two drugs i.e., Haridra and Daruharidra. The combination of Aamlaki ( Emblica officinalis Linn. ) Haridra ( Curcuma longa Linn.) and Daruharidra ( Berberis aristata D.C & Coscinium fenestratum Colebr.) is to be considered as “ Srestha ” (Drug of choice) in Diabetes mellitus. India leads the world’s largest number of diabetic subjects earning the dubious distinction of being termed the diabetes capital of the world. According to diabetes atlas 2008 published by Indian diabetic federation, the number of people with diabetes in India are currently around 40.9 million and is expected to rise to 69.9 million by 2025 unless urgent preventive measures are taken. In India, it is also 3 rd leading cause of death (After heart disease and cancer).It has turned out to be the biggest “silent killer” in today’s world. The present research work is done on 60 patients dividing them into 2 groups.DH1 Group was given with Aamalaki, Haridra and Daruharidra { Berberis aristata D.C}, DH2 Group was given with Aamalaki, Haridra and Daruharidra { Coscinium fenestratum Colebr.}. Finally it is concluded that Daruharidra which is known botanically as Berberis aristata D.C is highly effective in controlling the blood sugar levels in combination with Aamalaki and Haridra than Coscinium fenestratum Colebr. in combinations with Aamalaki and Haridra.


Introduction
Diabetes mellitus is one of the most common metabolic disorders. According to WHO "Diabetes is a major threat to global public Health that is rapidly getting worse, and the biggest impact is on adults of working age in developing countries" The total number of recorded diabetes patients till the year 2000 are 171 million and expecting to be increased by 366 million by the year 2030 (1). Prameha may be compared to diabetes mellitus because of the similarities in etiology, pathogenesis, clinical features & prognosis. Main Aim of A yurveda is to cure the disease & maintain health state, A yurvedathe science of life-though has its own principles, is incorporating new theories and drugs in it and presenting them according to its principles. Nishaamlaki is already known in Ayurvedic field and found effective in certain cases of Diabetes mellitus,But according to A sthanga hridaya while describing Agryasangraha Meheshudhaatrinishe is said to be best for Diabetes mellitus (2).
Few scholars have contributed their best on this topic and proved Haridra and A amalaki's role in Prameha. The present study is designed to add one more step to those contributions adding of Daruharidra and Haridra along with Aamalaki. According to Acharya Indu while commentating on'Nishe', in Astangasamgraha he mentioned Nishe as Pindaharidra and Daruharidra (3). Pindaharidra is a synonym of Haridra. Hence Nishe means Haridradwaya. Considering this sutra, we further move forwarded and prepared Dhaatrinishe compound preparation with the combination of Haridradwaya and A amalaki as per Indu.
Regarding the identity of Daruharidra, two plant spices are extensively used in the northern and southern parts of India. They are Berberis aristata D.C. and Coscinium fenestratum colebr. The present study is aimed to exactly identify the best combination in controlling Diabetes mellitus adding two varieties of Daruharidra to Haridra and Aamalaki in different combinations.

Aims and objectives
To

Clinical Study Materials and Methods
The patients having classical symptoms of Diabetes Mellitus have been selected from OPD of PG Department Of Dravyaguna, S.V. Ayurvedic Hospital, TTD, Tirupati, irrespective of Sex, Religion, and Occupation etc.
A special detailed Clinical Pro forma has been prepared incorporating selected symptoms and signs based on both A yurvedic and Modern description of the disease.
A detailed history has been taken and complete physical examination has been carried out.

Diet & Regimen
Patients were asked to go for Aerobic exercises for 15-20 minutes in a day along with other routine physical works as a part of their regular activities. They were advised to avoid Kaphavardhaka A hara, day sleep, alcohol, high calorie diet etc.

Follow-up
All the patients were reviewed for their fasting blood sugars and postprandial blood sugars on 30 th day and 60 th day during the treatment.

Investigations:  Fasting blood sugar levels (FBS)  Postprandial blood sugar levels (PPBS)
Criteria for the Assessment  Alleviation in the signs and symptoms of the disease as per A yurvedic texts.  Biochemical Investigations before and after the treatment.

Subjective criteria
The changes observed in the signs and symptoms were assessed by adopting suitable scoring pattern and the objective signs by using appropriate clinical tools. The detail assessment of clinical signs and symptoms are as follows: 1. Polyuria (Prabhuta Mutrata) Grading 3 -5 times per day, no or rarely at night

Discussion
The treatment continued for a period of 60 days for all the members of both of the groups and blood sugar levels are assessed at periodic intervals before and after treatment. At the end of 60 days the total results of the entire work was tabulated and were subjected for statistical study to clearly demonstrate the effect of 2 groups on the course of disease along with the values of significance.
At the end of 60 days fasting blood sugar levels of DH1 group patients have come down significantly, in comparison with the levels before the commencement of treatment. The t-test implied as 7.85 which is extremely significant at 0.01 levels. Postprandial blood sugar levels have come down significantly, in comparison with the levels before the commencement of treatment. The t-test implied as 6.64 which is extremely significant at 0.01 levels in the same group.
At the end of 60 days fasting blood sugar levels of DH2 group have come down significantly, in comparison with the levels before the commencement of treatment. The t-test implied as 3.14 which is very significant at 0.05 levels. Postprandial blood sugar levels have come down significantly, in comparison with the levels before the commencement of treatment. The t-test implied as 3.09 which is significant at 0.05 levels in the same group.
In the DH1 group 6 patients were showed marked improvement, 10 patients showed moderate improvement and 4 patients showed mild improvement in the total number of 20 patients.
In the DH2 group 2 patients showed marked improvement, 7 patients showed moderate improvement, 10 patients showed mild improvement and 1 patent showed no improvement in the total number of 20 patients.

Probable mode of Action
Haridra is used since time immemorial in different indications including Madhumeha. This drug is used both internally and externally also in healing ulcers due to Madhumeha. Haridra has got Katu, Tikta rasa, Katu vipaka, Ushna veerya and Ruksha guna (5). The therapeutic action of this drug in the management of the Prameha cannot be explained through the Rasapanchaka only but possible through Prabhava. Useful part of Haridra is Driedrhizome which is used clinically (6). Haridra contains curcumin, curcuminoids, other volatile oils and some coloring substances (7).Many modern research workers from different countries including institutes in India have reported about its hypoglycemic property in Type 2 diabetes.
Aamalaki is used extensively for many centuries as a household remedy for many ailments and also scientifically for its action on Madhumeha, which is due to its Rasayana property. This drug A amalaki has got five Rasas except Lavana rasa but predominated by Amla rasa. The part used in this plant is its fruit rind. It has Guru, Ruksha gunas, Madhura vipaka and Seetha veerya (8). Chemically, Aamalaki contains many watersoluble tannins like Emblicannins, which are supposed to be the main active principles, behind decreasing the cellular resistance to insulin. The controversy of the presence of ascorbic acid and vitamin 'c' did not lessen its popular utility. Undoubtedly, A amalaki is proved to be quite effective both experimentally and clinically as a promising hypoglycemic drug (9).
Daruharidra has been mentioned in context of Madhumeha treatment by Charaka, Susruta Regarding the identity of Daruharidra, two plant spices are extensively used in the northern and southern parts of India. They are Berberis aristata D.C. and Coscinium fenestratum colebr. Surprisingly both the drugs have got common chemical constituents like Berberine and both are almost equally efficacious in the management of Diabetes mellitus.

Conclusion
Combination of A amalaki, Haridra and Daruharidra clearly exhibited the anti-diabetic activity. They are useful as individual ingredients also.
After completing the duration of treatment, it was found that the compound preparation of A amalaki, Haridra and north Indian market drug of Daruharidra showed the highest significant activity in reducing the blood sugar levels and the intensity of clinical symptoms in comparison with the South Indian market drug of Daruharidra.
As a sample study is very small it requires a larger group of patients for further evaluation.