NCT06846138

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Pauls Stradins Clinical University Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-25
• Last updated: 2025-07-17

Locations

1 site across 1 country: Latvia