• Dr Shweta Gyanendra Shukla
• Prof O P Singh
• prof Sanjay kumar Tripathi

BACKGROUND Dozens of preventive and therapeutic drugs have been developed and examined for its potential benefits in Type-2 Diabetes mellitus (DM) in past decades. Regardless of the efforts putforth, the disease has now emerged as a major public health problem that is approaching epidemic proportions globally. Based on the previous investigative studies on the restorative and curative therapeutic potential of the components of the drug Bhudhatrikadi Yoga (i.e., Bhudhatri and Maricha), it is assumed to curtail the risk of complications related to the disease along with controlling the glycemic index. However, the study needs further authentication in substantial samples, standard-controlled, and randomized clinical trials. OBJECTIVE This clinical study is designed to determine the efficacy and safety of Bhudhatrikadi Yoga in Madhumeha DM2 compared with Metformin. MATERIAL AND METHODS This prospective, open-label, randomized, active control, parallel-group trial will be conducted at Uttarakhand Ayurved University, Rishikul Campus Haridwar. A total of 60 participants in patients of any gender aged 30-60 years with DM2 having Fasting blood glucose levels>110mg/dl <250mg/dl & post-prandial blood sugar levels>140mg/dl and <350mg/dl and HBA1C >6% to <10% will be considered for enrolment in the study. The enrolled participants will be randomly divided into two groups. Group A patients will be administered 5 gm Bhudhatrikadi Yoga twice daily before meal. Patients of group B will be administered metformin 500 mg twice daily before meals for 90 days. The outcome measures are changes in Blood Sugar- Fasting, Blood Sugar- Post-prandial, HbA1c, Urine Sugar, and BMI. Patients will also be assessed for graded subjective parameters on each visit. Safety will be assessed based on the incidence of adverse events and changes in the liver and kidney function tests. DISCUSSION Ayurvedic formulations have been used for the management of Madhumeha in routine clinical practice. However, the use of Ayurvedic intervention with lifestyle modification is less common. So it is expected that the outcomes of this trial will suggest probable therapeutic options for the effective management of Madhumeha DM2. TRIAL REGISTRATION CTRI/2022/07/043884(clinical trial registry of India) registered on 11/07/22.

Madhumeha, Diabetes, Bhudhatrikadi Yoga.

"A PROSPECTIVE STANDARD CONTROLLED CLINICAL TRIAL OF BHUDHATRIKADI YOGA WITH LIFESTYLE MODIFICATION IN MADHUMEHA (TYPE -2 DIABETES MELLITUS)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.d147-d157, June-2024, Available :http://www.jetir.org/papers/JETIR2406317.pdf

"A PROSPECTIVE STANDARD CONTROLLED CLINICAL TRIAL OF BHUDHATRIKADI YOGA WITH LIFESTYLE MODIFICATION IN MADHUMEHA (TYPE -2 DIABETES MELLITUS)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppd147-d157, June-2024, Available at : http://www.jetir.org/papers/JETIR2406317.pdf