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Enrolling by invitation NCT06846138

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

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polyherbal Formulation (PHF), Placebo, Metformin (Standard Treatment for Type 2 Diabetes).
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 25 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Latvia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Change in Glycemic Control (HbA1c Levels) [Time frame: Baseline, Week 24, Week 48]
Secondary outcome measures (8)
  • Relative Abundance of Key Bacterial Taxa in Gut Microbiota [Time frame: Baseline, Week 2, Week 24, Week 25, Week 48]
  • Gastrointestinal Tolerability of Metformin [Time frame: Baseline, Week 2, Week 24, Week 25, Week 48]
  • Fasting and Postprandial Blood Glucose Levels [Time frame: Baseline, Week 24, Week 48]
  • Time in Range (TIR) Measured by Continuous Glucose Monitoring (CGM) [Time frame: Week 1]
  • Metabolomic Analysis of Stool Samples (Short-chain fatty acids (SCFAs)) [Time frame: Baseline, Week 24, Week 48]
  • Patient-Reported Outcomes on Quality of Life [Time frame: Baseline, Week 24, Week 48]
  • Metabolomic Analysis of Stool Samples (Amino acids) [Time frame: Baseline, Week 24, Week 48]
  • Metabolomic Analysis of Stool Samples (Bile acids) [Time frame: Baseline, Week 24, Week 48]

Eligibility criteria

Inclusion criteria

Participants must meet all of the following criteria to be eligible for enrollment:

Clinical diagnosis of Type 2 Diabetes Mellitus (T2D) HbA1c level between 6.5% and 8.5% On a stable dose of oral antidiabetic therapy for at least 6 months Age: ≥ 25 years and ≤ 80 years History of metformin intolerance, defined as previously reported gastrointestinal side effects or inability to tolerate full-dose metformin Willing and able to provide written informed consent Willing to comply with study procedures, including stool sample collection and continuous glucose monitoring (CGM)

Exclusion criteria

Participants will be excluded if they meet any of the following criteria:

Type 1 Diabetes Mellitus Current or recent (last 6 months) use of polyherbal formulations (PHF) Pregnancy or breastfeeding

Severe diabetic complications, such as:

Diabetic ketoacidosis Proliferative retinopathy Chronic kidney disease Stage IIIb or higher (eGFR <45 mL/min/1.73m²)

Recent cardiovascular events (within the last 6 months), including:

Stroke Myocardial infarction Unstable angina Heart failure

Severe systemic disease that could interfere with participation, such as:

Active cancer Severe autoimmune disease Current antibiotic therapy (within 2 months of study enrollment) Use of probiotics or prebiotics (within 1 month of study enrollment)

Severe gastrointestinal conditions, including:

Inflammatory bowel disease Chronic diarrhea of unknown origin Severe infection requiring antibacterial therapy Participation in another interventional study within the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Latvia · 1 center
  • Pauls Stradins Clinical University Hospital — Riga

Identifiers

NCT: NCT06846138 · lzp-2023/1-0422 · lzp-2023/1-0422

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗