MedTrace Logo

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

NCT07279909 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-12-12

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Jinnah Postgraduate Medical Centre

    collaborator OTHER_GOV

  • Hamdard University

    lead OTHER

Principal Investigators

  • Mehboob Alam, PhD · Department of Pharmacology, Institute of Basic Medical Sciences, JPMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-09
Primary Completion
2025-08-01
Completion
2026-05-20

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279909 on ClinicalTrials.gov