NCT07279909

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

Pre-Clinical & Clinical Studies on Poly Herbal Anti-Diabetic Formulation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Hamdard University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Detailed description

Preclinical evaluation studies including stability, dissolution and anti-microbial testing were performed. The formulation was also subjected to gas chromatography-mass spectrometry (GCMS). The powdered formulation was analyzed for LD-50 followed by two-center, unblinded, non-randomized controlled clinical trial with convenient sampling was conducted over 24 weeks in 500 adults with T2DM (HbA1c 7.5-10%). Participants were assigned to receive either polyherbal capsules (\~500 mg three times daily, n = 250) or metformin (500 mg three times daily, n = 250). Primary outcome was HbA1c reduction; secondary outcomes included fasting/postprandial glucose, urinary protein, urinary glucose, lipid profile, body weight, and safety. Statistical analyses were performed using two-way ANOVA and unpaired t-tests.

Conditions

• Diabetes Type 2
• Diabetes Mellitus, Experimental
• HbA1c
• Urinary Glucose
• Ability of Experimental Drug to Lower HbA1c Compare to Metformin

Interventions

Type	Name	Description
DRUG	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.
DRUG	Metformin	Standard oral hypoglycemic comparator

Timeline

• Start date: 2024-03-09
• Primary completion: 2025-08-01
• Completion: 2026-05-20
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Pakistan