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

Hamdard University

Status and phase: Active, not recruiting; Phase 3

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

Treatments: Drug: Metformin; Drug: DIAB-PHC1

Study type: Interventional

Funder types: Other

Identifiers

NCT07279909

DIAB-PHC1

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Metformin - control are of the study

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

DIAB-PHC1 - Treatment arm of the study

Experimental group

Description:

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

Treatment:

Drug: DIAB-PHC1