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TO SEE WHETHER PROBIOTIC SUPPLEMENTATION IMPROVES HORMONAL PROFILE IN PCOS(POLYCYSTIC OVARIAN SYNDROME)WOMEN

EFFECT OF PROBIOTICS SUPPLEMENTATION ON HORMONAL PROFILE, LEVELS OF INFLAMMATORY BIOMARKERS AND OXIDATIVE STRESS IN WOMEN WITH POLYCYSTIC OVARIAN SYNDROME -A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045302
Enrollment
80
Registered
2022-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: PROBIOTIC CAPSULE: PROBIOTIC CAPSULE (lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus plantarum, lactobacillus casei, lactobacillus fermentum, a

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed PCOS women by Rotterdamââ?¬•s criteria with the presence of any two of the following: I) Oligomenorrhea/ dysmenorrhea. II) hyperandrogenism/hyperandrogenemia hirsutism, acne and male pattern baldness III) polycystic ovarian morphology on USG Aged 18 to 45 years, whose testosterone is more than 76ng/dl and are started on standard treatment (Life style modification/metformin / metformin+ OCP / antiandrogen) visiting the outpatient Department of Obstetrics and Gynaecology

Exclusion criteria

Exclusion criteria: 1. Hyperandrogenism due to causes other than polycystic ovarian syndrome such as Cushingââ?¬•s, hyperprolactinemia, adrenal tumors and late onset congenital adrenal hyperplasia. 2. Inflammatory bowel disease and cancers in GIT (carcinoid syndrome) 3. Major surgery in the GIT (colostomy, Whipple procedure) 4. Chronic diseases like thyroid dysfunction, SLE and other autoimmune disorders. 5. Past history of antibiotics usage within a period of last one month. 6. Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
TO look for a decrease in serum total testosterone levelTimepoint: baseline value and after 3 months

Secondary

MeasureTime frame
to look for values like MDA( malondialdehyde), TAC(total antioxidant capacity) and hsCrp(high sensitive C reactive protein)Timepoint: baseline value and after 3 months

Countries

India

Contacts

Public ContactKARTHIK J

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

shalipriya85@gmail.com9994713080

Outcome results

None listed

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