This clinical trial will study how metformin and orlistat influence gut bacteria in women with Polycystic Ovarian Syndrome (PCOS)and track gut bacteria changes and investigate their effects on PCOS symptoms, including weight, insulin resistance, and hormone levels.

Orlistat Versus Metformin induced Gut micro-organisms modification in Polycystic ovarian syndrome patients -A Randomized controlled study - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080001

Enrollment

Registered

2025-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: ORLISTAT: 60 MG TWICE DAILY FOR 3 MONTHS Control Intervention1: METFORMIN: 500 MG ONCE DAILY FOR 3 MONTHS

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed as PCOS according to ROTTERDAM CRITERIA With at least two of the following features : Oligo-amenorrhea or chronic anovulation Clinical and/or biochemical hyperandrogenism Ultrasound appearance of polycystic ovaries Able and willing to comply with the interventions and follow-up evaluations

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Gut bacterial diversity before and after the treatment with metformin and orlistat in PCOS Timepoint: 3 months	—

Secondary

Measure	Time frame
Effects of Orlistat and Metformin in improvement of clinical and metabolic profile in PCOS patients Timepoint: 6 moths	—

Countries

India

Contacts

Public ContactDivyabharathi

SRM INSTITUTE OF SCIENCE AND TECHNOLOGY

saswatit@srmist.edu.in9677364713

Outcome results

None listed

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