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Investigating the Effectiveness of Continuous vs Stepwise Lifestyle Change Strategies in PCOS for 12 months: A Multicentric Randomized Study

Evaluation of Comparative efficacy of Continuous vs. Stepwise Implementation Approaches for 12 -Month Lifestyle Medicine Interventions among Polycystic Ovarian Syndrome Patients: A Multicentric Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090805
Enrollment
612
Registered
2025-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

None listed

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants who will provide informed consent& available for follow-up assessments indicating their willingness to participate in the research study, including undergoing randomization to either the continuous or stepwise implementation group. 2. Subjects having diagnosis of PCOS based on modified Rotterdam criteria 3. Patients taking following standard of care treatment for PCOS a. Hormonal Treatment (Oral Contraceptive) 30 mcg Ethinyl Estradiol + 150 mcg Levonorgestrel, Once daily (for 21 days followed by 7-day break) b. Insulin-Sensitizing Agent Metformin, 1000 mg, Twice daily Myoinositol, 1000 mg, Once daily

Exclusion criteria

Exclusion criteria: 1.Participants who are currently pregnant & breastfeeding, as breastfeeding can also impact hormonal levels and may interfere with the interventions or assessments. 2.Participants with severe medical conditions which include uncontrolled diabetes, , severe mental health disorders. 3.Participants with hyperprolactinemia and thyroid abnormality 4.Participants taking medicines as antipsychotics drugs, antidepressants drugs. 5.Presence of other causes of androgen excess and anovulatory infertility, such as: Congenital adrenal hyperplasia, Cushing syndrome, Androgen-secreting tumors 6.History of bariatric surgery or planning to undergo other weight loss strategies during the study period. 7.Women with lower limb pathology or any condition that precludes participation in physical activity.

Design outcomes

Primary

MeasureTime frame
To compare the effect of continuous Vs stepwise lifestyle medicine interventions over 12 months in terms of improving PCOS Assessments: Ovarian volume, Menstrual cycle history, Polycystic Ovarian morphology, hormonal and biochemical assay, dietary assessment etc.Timepoint: Baseline, every 15 days for first 2 months, followed by every month till 12 months—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactCharushila Rukadikar

All India Institute of Medical Sciences Gorakhpur

charuruks11@gmail.com9689865748

Outcome results

None listed

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