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

NCT07279909 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: DIAB-PHC1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

• 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

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

Keywords

Polyherbal formulation; GCMS; Syzygium cumini; Momordica charantia; Wrightia tinctoria,; Gymnema sylvestre,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Urinary Proteins

  At least Six months

• Urinary Glucose

  6 months

Study Arms (2)

Metformin - control are of the study

ACTIVE COMPARATOR

Metformin is standardized hypoglycemic agent with global accepted efficacy \& safety

Drug: Metformin

DIAB-PHC1 - Treatment arm of the study

EXPERIMENTAL

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

Interventions

DIAB-PHC1 DRUG

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.

DIAB-PHC1 - Treatment arm of the study

Metformin DRUG

Standard oral hypoglycemic comparator

Also known as: Glucophage

Metformin - control are of the study

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: this is not a very much common situation in Pakistan
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamdard University: lead
• Jinnah Postgraduate Medical Centre: collaborator

Study Sites (1)

Mehboob Faryal Diagnostic Center

Karachi, Sindh, 74700, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Experimental

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mehboob Alam, PhD

  Department of Pharmacology, Institute of Basic Medical Sciences, JPMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Trials

Model Details: Non-randomized control trial. Two study arms. Test drug (polyherbal drug) and control group. Treatment in the both arms for 6 months at-least. Follow-up every 15 days. Revise clinical investigations of HbA1c, Urinary proteins and glucose

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: March 9, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): May 20, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)