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Phase-III Clinical Studies on Poly Herbal Anti-Diabetic Formulation
Sponsor: Hamdard University
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
Official title: Pre-Clinical & Clinical Studies on Poly Herbal Anti-Diabetic Formulation
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-03-09
Completion Date
2026-05-20
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
DIAB-PHC1
a novel poly-herbal hard gelatin capsule formulation comprising Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in a scientifically optimized ratio. Although each of these herbs is traditionally recognized for its individual anti-diabetic activity, their combination in a standardized dosage form has not previously been reported. The study further strengthens its novelty by conducting comprehensive pre-clinical safety evaluations, confirming the absence of toxicity before proceeding to controlled clinical investigations.
Metformin
Standard oral hypoglycemic comparator
Locations (1)
Mehboob Faryal Diagnostic Center
Karachi, Sindh, Pakistan