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

NCT ID: NCT07279909

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-09
• Study Completion Date: 2026-05-20

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin - control are of the study

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Standard oral hypoglycemic comparator

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

Group Type: EXPERIMENTAL

DIAB-PHC1

Intervention Type: 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.

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.

Intervention Type: DRUG

Metformin

Standard oral hypoglycemic comparator

Intervention Type: DRUG

Other Intervention Names

Glucophage

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: collaborator

Hamdard University

OTHER

Sponsor Role: lead

Responsible Party

Abdul Bari

Head of Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehboob Alam, PhD

Role: STUDY_DIRECTOR

Department of Pharmacology, Institute of Basic Medical Sciences, JPMC

Locations

Mehboob Faryal Diagnostic Center

Karachi, Sindh, Pakistan

Countries

Pakistan

Study Documents

Document Type: Main reference

it is the main reference used to identify definitions of the Diabetes \& its complications

View Document

Related Links

https://diabetes.org/

Related Info

Other Identifiers

DIAB-PHC1

Identifier Type: -

Identifier Source: org_study_id