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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Type 2; HbA1c; Diabetes Mellitus, Experimental; Urinary Glucose; Ability of Experimental Drug to Lower HbA1c Compare to Metformin
• Intervention / Treatment: Drug: Metformin; Drug: DIAB-PHC1

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74700
      • Mehboob Faryal Diagnostic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients having Type II Diabetes Mellitus.
• Patients agree willingly to use study medicine throughout the study
• Patients having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
• Patients over 30 years of age.
• Patients of both genders will be included in the study.

Exclusion Criteria:

• Patients who do not agree willingly to participate in research.

  • Patients having history of any chronic organ failure.
  • Patients having history of any amputation.
  • Patients having history of treated or diagnosed cancer of any organ.
  • Pregnant and lactating mothers.
  • Patients who are having brittle Diabetes
  • Known under treatment cases of psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin - control are of the study; Metformin is standardized hypoglycemic agent with global accepted efficacy & safety	Drug: Metformin; Standard oral hypoglycemic comparator; Other Names: Glucophage
Experimental: DIAB-PHC1 - Treatment arm of the study; The investigational formulation consisted of Syzygium cumini, Momordica charantia, Wrightia tinctoria and Gymnema sylvestre. Raw plant materials were procured from local herbal markets and authenticated shade dried and powdered. The powder was capsulated with avverage weight of 500 mg /capsule. Capsules were given TID with meals to the patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycated hemoglobin (HbA1c)	The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose.	From two weeks to six months time period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Proteins	The secondary objectives are to evaluate reduction in the amount of proteins in urine	At least Six months
Urinary Glucose	regular check for the urinary glucose levels as a parameter for improved glycemic control	6 months

Collaborators and Investigators

• Sponsor: Hamdard University
• Collaborators: Jinnah Postgraduate Medical Centre
• Investigators: Study Director: Mehboob Alam, PhD, Department of Pharmacology, Institute of Basic Medical Sciences, JPMC

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Momordica charantia; GCMS; Polyherbal formulation; Syzygium cumini; Wrightia tinctoria,; Gymnema sylvestre,
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus, Experimental; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: DIAB-PHC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: to keep the privacy & anonymity of the individual participant of the study, as committed at the time of induction

Study Data/Documents

1. Main reference
   Information comments: it is the main reference used to identify definitions of the Diabetes & its complications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No