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ENROLLING BY INVITATION
NCT06846138
NA

Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study

Sponsor: Pauls Stradins Clinical University Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

25 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-03-01

Completion Date

2026-12-01

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Polyherbal Formulation (PHF)

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).

OTHER

Placebo

Type: Placebo Comparator Description: A placebo formulation that matches PHF in appearance, texture, and administration schedule. Administration: Oral, daily dosage as per study protocol.

DRUG

Metformin (Standard Treatment for Type 2 Diabetes)

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.

Locations (1)

Pauls Stradins Clinical University Hospital

Riga, Latvia