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Evaluating The desired effect Of the drug Imeglimin In Patients With Polycystic Ovarian Syndrome

A Double Blind Randomized Placebo Controlled Pilot Study Evaluating The Efficacy Of Imeglimin In Patients With Polycystic Ovarian Syndrome - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068921
Enrollment
100
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: metformin with Imeglimin and metformin with placebo: metformin 500 mg once daily with Imeglimin 500 mg Once daily for 6 months for one group and metformin 500 mg once daily with plac

Sponsors

Riya Sharma self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Polycystic ovarian syndrome diagnosed patient with BMI = 25 kg/m2 -Patients willing to give informed consent.

Exclusion criteria

Exclusion criteria: -History of allergic reactions attributed to compounds of similar chemical or biologic composition of metformin or imeglimin -Patients with history renal dysfunction (documented in biochemical test), acute / chronic metabolic acidosis, congestive cardiac failure needing drug treatment, lactic acidosis -Patients on drug known to have significant drug-drug interactions either metformin or imeglimin -Pregnant females

Design outcomes

Primary

MeasureTime frame
Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for insulin resistance (HOMO-IR)Timepoint: Two years

Secondary

MeasureTime frame
- Hyperandrogenism using S.Testosterone - Inflammation using AGEs, MDA,CRP - ADRs in both arm using WHO-UMC Causality assessment scale - Quality of life of polycystic ovarian syndrome patients will be assessed using a questionnaire Timepoint: Two years

Countries

India

Contacts

Public ContactDr Waseem Rizvi

Jawaharlal Nehru Medical College Aligarh Muslim University

waseemnakhat@gmail.com9897686003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026