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Active, Not Recruiting

NCT Number: NCT07279909

Phase-III 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Type 2 Ability of Experimental Drug to Lower HbA1c Compare to Metformin Diabetes Mellitus Diabetes Mellitus, Experimental Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders HbA1c Metabolic Diseases Nutritional and Metabolic Diseases Urinary Glucose

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mehboob Faryal Diagnostic Center

Karachi, Sindh, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

metformin

Drug

Standard oral hypoglycemic comparator

Other names: Glucophage

Primary outcomes

  1. glycated hemoglobin (HbA1c)

    Time frame: From two weeks to six months time period

    The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose.

Secondary outcomes

  1. Urinary Proteins

    Time frame: At least Six months

    The secondary objectives are to evaluate reduction in the amount of proteins in urine

  2. Urinary Glucose

    Time frame: 6 months

    regular check for the urinary glucose levels as a parameter for improved glycemic control

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Collaborators

  • Jinnah Postgraduate Medical Centre

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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