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effect of probiotics on inflammation and oxidative stress in PCOS women

Effect of Probiotic supplementation on markers of inflammation and oxidative stress in Indian women with PCOS - a randomised open label clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080020
Enrollment
200
Registered
2025-02-07
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: E889- Metabolic disorder, unspecified

Interventions

Intervention1: Arm 1 : Metformin 1000mg + Multistrain probiotic Capsule: Subjects will be randomized to receive treatment for a period of 24 weeks as Group 1: Metformin 1000mg once daily + Diet (30-Kc

Sponsors

Department of Health Research ,ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All women aged 20 to 40 years diagnosed with PCOS by Rotterdam 2003 Criteria

Exclusion criteria

Exclusion criteria: Disease like adrenal hyperplasia, hypo/hyperthyroidism, endometriosis, ovarian tumour, etc.Pregnancy,Lactation and use of OCP"s,Steroids and antiandrogens.

Design outcomes

Primary

MeasureTime frame
The study will investigate the effect of probiotic supplementation on 1. clinical ,biochemical and hormonal parameters. 2.markers of inflammation 3. oxidative stress levelsTimepoint: The study subjects will be assessed at baseline, 12 weeks and 24 weeks after supplementation.—

Secondary

MeasureTime frame
The study will also investigate the effect of probiotic supplementation on gut microbiome in PCOS womenTimepoint: The gut microbiome will be evaluated at baseline , 12 week and 24 week follow up—

Countries

India

Contacts

Public ContactDr Aafia Rashid

Govt Medical College, Srinagar

aaffia.rashid@gmail.com09796561754

Outcome results

None listed

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