Enrolling By Invitation
NA
INTERVENTIONAL
NCT06846138
Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Study population: Type 2 diabetes patients Design of the study: Randomized, two-arm, placebo-controlled, and prospective crossover cohort study. Objective: To evaluate the effects of interactions between metformin and traditionally used polyherbal formulations on gut microbiota in a prospective crossover study involving type 2 diabetes mellitus patients. Sample size: 66 patients. Duration of study: 06/2024 - 12/2026
Interventions
Name:
Polyherbal Formulation (PHF)
Type:
DIETARY_SUPPLEMENT
Description:
Description: A polyherbal formulation with known beneficial effects on gut microbiota and metabolic regulation. The formulation contains selected plant extracts studied for their hypoglycemic, antioxidant, and gut microbiota-modulating properties.
Administration: Oral, daily dosage as per study protocol. Supplier: Arya Vaidya Pharmacy (AVP), Coimbatore, India (GMP-certified).
Name:
Placebo
Type:
OTHER
Description:
Type: Placebo Comparator Description: A placebo formulation that matches PHF in appearance, texture, and administration schedule.
Administration: Oral, daily dosage as per study protocol.
Name:
Metformin (Standard Treatment for Type 2 Diabetes)
Type:
DRUG
Description:
Description: Metformin is an FDA and EMA-approved antihyperglycemic medication that improves glycemic control by reducing hepatic glucose production and enhancing insulin sensitivity.
Administration: Oral, per standard dosing guidelines. Availability: Provided to all participants per the national reimbursement scheme for T2D patients in Latvia.
Primary Outcomes
Measure:
Change in Glycemic Control (HbA1c Levels)
TimeFrame:
Baseline, Week 24, Week 48
Description:
Measurement of HbA1c (%) to evaluate the impact of PHF on glycemic control compared to placebo.
Trial Information
NCT ID
NCT06846138
Status
Enrolling By Invitation
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Pauls Stradins Clinical University Hospital
Last Updated
December 15, 2025