Trial · NCT06846138
Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study
NCT06846138, Not applicable, Enrolling by invitation, Pauls Stradins Clinical University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study. Trials, record NCT06846138. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06846138
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study
- NCT number
- NCT06846138
- Status
- Enrolling by invitation
- Phases
- Not applicable
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Polyherbal Formulation (PHF), Placebo, Metformin (Standard Treatment for Type 2 Diabetes)
- First posted
- 2025-02-25
- Last updated
- 2025-07-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Glycemic Control (HbA1c Levels) | Baseline, Week 24, Week 48 | Measurement of HbA1c (%) to evaluate the impact of PHF on glycemic control compared to placebo. |
| Secondary | Relative Abundance of Key Bacterial Taxa in Gut Microbiota | Baseline, Week 2, Week 24, Week 25, Week 48 | Description: Measurement of the relative abundance of specific bacterial taxa (Akkermansia muciniphila, Escherichia spp., Intestinibacter) in fecal samples using metagenomic sequencing. |
| Secondary | Gastrointestinal Tolerability of Metformin | Baseline, Week 2, Week 24, Week 25, Week 48 | Assessment of gastrointestinal side effects, including nausea, bloating, diarrhea, and abdominal discomfort, using a standardized gut microbiota-related symptom questionnaire. Scale Name: Gastrointestinal Symptom Rating Scale (GSRS) Score Range: Minimum = 0, Maximum = 4 Interpretation: Lower scores indicate better gastrointestinal tolerability. |
| Secondary | Fasting and Postprandial Blood Glucose Levels | Baseline, Week 24, Week 48 | Measurement of fasting and postprandial glucose levels using standard biochemical assays. Unit of Measure: mmol/L |
| Secondary | Time in Range (TIR) Measured by Continuous Glucose Monitoring (CGM) | Week 1 | Time in Range (TIR) Measured by Continuous Glucose Monitoring (CGM) Description: Measurement of the percentage of time that blood glucose levels remain within the target range (70-180 mg/dL) using data from Continuous Glucose Monitoring (CGM). |
| Secondary | Metabolomic Analysis of Stool Samples (Short-chain fatty acids (SCFAs)) | Baseline, Week 24, Week 48 | The levels of acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, and caproic acid will be quantified using gas chromatography-mass spectrometry (GC-MS). These concentrations will be reported in micromoles per gram of fecal matter (μmol/g). |
| Secondary | Patient-Reported Outcomes on Quality of Life | Baseline, Week 24, Week 48 | Description: Evaluation using a validated diabetes-related quality of life questionnaire. Diabetes Quality of Life (DQOL) Questionnaire. Scoring: Items are scored on a 5-point Likert scale, with higher scores typically indicating more negative impacts or dissatisfaction. |
| Secondary | Metabolomic Analysis of Stool Samples (Amino acids) | Baseline, Week 24, Week 48 | The following amino acids will be analyzed using ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS): acetylcarnitine, arginine, butyrylcarnitine, carnitine, citrulline, creatinine, glutamic acid, glutamine, histidine, isoleucine, leucine, lysine, methionine, ornithine, phenylalanine, proline, serotonin, taurine, tryptophan, tyrosine, and valine. Results will be expressed in nanomoles per gram of fecal matter (nmol/g). |
| Secondary | Metabolomic Analysis of Stool Samples (Bile acids) | Baseline, Week 24, Week 48 | The bile acids to be measured include cholic acid, chenodeoxycholic acid, deoxycholic acid, and lithocholic acid, along with their conjugated forms: glycocholic acid, glycochenodeoxycholic acid, glycodeoxycholic acid, glycolithocholic acid, taurocholic acid, taurochenodeoxycholic acid, taurodeoxycholic acid, taurolithocholic acid, and ursodeoxycholic acid. These will be quantified using liquid chromatography-mass spectrometry (LC-MS), with concentrations reported in micromoles per gram of fecal matter (μmol/g). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06846138
GET https://conductscience.org/api/trials/v1/NCT06846138/registered