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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
Diabetes Mellitus Type 2
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."

Trial Locations (1)

LV-1002

Pauls Stradins Clinical University Hospital, Riga

All Listed Sponsors
lead

Pauls Stradins Clinical University Hospital

OTHER

NCT06846138 - Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study | Biotech Hunter | Biotech Hunter