Research Protocol
Efficacy of Salmusta Yoga versus Tablet Metformin in Type 2 Diabetes Mellitus (Madhumeha): A Research Protocol for Randomised Controlled Trial
JK01-JK04
Correspondence
Dr. Diksha Jitendra Gaikwad,
Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Datta Meghe Institute of Higher Education and Research (Deemed to be University), Wardha-442001, Maharashtra, India.
E-mail: diksha.gaikwad550@gmail.com
Introduction: Diabetes mellitus is a metabolic disorder that can be correlated with Madhumeha, a type of Prameha in Ayurveda. This is a Santarpanajanya Vyadhi (Diseases caused by overnutrition), caused by Medo Dushti (disruption in fat metabolism) affecting Medovaha Strotas. Salmusta yoga, containing Sal (Shorea robusta) , Musta (Cyperus rotundus) , and Kampillaka (Mallotus philippensis) in Yogratnakar for the management of Prameha (Diabetes mellitus).
Need of the study: Type 2 Diabetes Mellitus (T2DM) is a rapidly increasing metabolic disorder with significant complications. Although modern treatments like insulin and metformin are effective, long-term use may cause adverse effects and does not fully address underlying metabolic disturbances. In Ayurveda, Madhumeha involves Kapha predominance, Medo Dushti, and Agnimandya, requiring a holistic approach. Shamana Chikitsa is preferred when Shodhana is not feasible. Salmusta yoga, described in Yogaratnakara, has Kapha-Medohara and Pramehaghna properties reported to have antihyperglycaemic effects. However, limited clinical evidence exists, highlighting the need to evaluate its efficacy in managing Madhumeha.
Aim: Evaluation of comparative efficacy of Salmusta yoga Versus tablet metformin in the management of diabetes mellitus type 2.
Materials and Methods: A single-blind (accessor blind) parallel randomised controlled trial will be conducted at the Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H) Wardha, Maharashtra, India, from September 2025 to March 2027. The study involves 64 patients meeting the inclusion criteria, randomly assigned into two groups of 32 each. Group 1 will receive Salmusta yoga, while Group 2 will receive tablet metformin twice a day for two months. Assessments of fasting and postprandial blood sugar level will be conducted on days 0, 30 and 60. Chi-square test, Student’s unpaired, and paired t-test will be used for both descriptive and inferential statistics. A significance level of p<0.05 will be applied.