Diabetes mellitus is a sovereign disease considered as one of the arch-enemies of mankind, resulting due to faulty diet and lifestyle. It is a group of metabolic disorders characterized by hyperglycemia caused by an absolute or relative deficiency of Insulin There are 3 main types of Diabetes mellitus - 1) Type-1 DM 2) Type-2 DM 3) Gestational DM. In Ayurveda texts, the characteristic features of "Madhumeha" shows remarked resemblance with the syndrome of Diabetes Mellitus -2 (Type-2 DM). Madhumeha  is a tridoshaja vyadhi but our ancient scholars mainly emphasized on vitiation of Kapha dosha, Medodusthi and Meda dhatwagni mandya. For disintegrating the pathogenesis, there must be a single drug or a formulation at the level of dhatwagni and counteracting Kapha dosha and Meda dhatu. 

Guduchi (Tinospora cordifolia) is having Katu-Tikta-Kashaya Rasa, Laghu Guna, Ushna veerya and Tridoshaghna activity which may help in the disintegration of the pathogenesis of Madhumeha. Again in Madhumeha, there is Ojakshyaya (Oja is equivalent to Bala) and Guduchi is having the property of Balya and Rasayana. Regarding the form in which Guduchi is used, classics of Ayurveda have advised using it in "Ardra" (fresh) form but in day to day practice unfortunately it is used in the "Shushka" form. Further, a few works have been reported towards evaluating the efficacy of the classically mentioned use of "Ardra Guduchi". Therefore, a clinical study to compare the anti-diabetic effect of Tinospora cordifolia - ardra (TCa) and Tinospora cordifolia - shushka (TCs) is planned. 

OBJECTIVES OF RESEARCH - 

1. Primary objective - To assess clinically the comparative anti-diabetic activity of Ardra (TCa) and Shushka (TCs) Guduchi.

2. Secondary objectives - * Analytical study (HPLC, HPTLC) of TCa and TCs.

                                         * Quality of Life (QOL) Assessment

METHODOLOGY - 

1. Drug Identification - Certification from taxonomist and Dravyaguna specialist will be taken and a voucher specimen will be preserved.

2. Drug Analysis - Analysis of TCa and TCs in HPLC and HPTLC method.

3. Drug Preparation - The drugs are prepared in the college pharmacy or procured from any reputed pharmacy as suitable.

4. Study Design- Three Armed Randomised Standard Controlled Trial.

5. Sample Size = Total 60 ( 20 in each group)

6. Group - A  (TCa + Lifestyle modification) - TCa Ghan (aqueous solid extract) tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.

7. Group - B (TCs + Lifestyle modification) - TCs Ghan tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.

8. Group - C (Standard control) (Glimepiride + Lifestyle modification + Placebo capsules of wheat powder) - Glimepiride (1mg) tablets and 1 placebo capsule once a day (or titrate as per blood glucose level) orally 15 minutes before breakfast with water.

9. Duration - 3 months 

10. Purpose of the trial - The purpose of the trial is the same as the primary objective of the research i.e. to evaluate clinically the comparative antidiabetic activity of Ardra & Shushka Guduchi (TCa and TCs).

11. Findings if any - As the patient recruitment is not started yet henceforth the findings are going to be evaluated after completion of the study.

12. Publication details - After completion of the thesis work, the study will be published in peer-reviewed journals.