Phase-III Clinical Studies on Poly Herbal Anti-Diabetic Formulation

Summary

The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is 1. Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics 2. Is the herbal combination therapy is safe for human use 3. Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID. * The recruited patients will continue the assigned therapy for at least six months * They visit the clinical trial OPDs fortnightly * They will record their fasting blood glucose with the glucometer at least two to three times a week and get the basal tests done in three-month time

Timeline

Start

2024-03-09

Primary completion

2025-08-01

Completion

2026-05-20

Drugs

Indications