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A study to find out if yoga and lifestyle changes can improve symptoms and health in women with PCOS.

Effect of Structured Lifestyle and Dietary Modification in Addition to Yoga on Clinical, Metabolic and Hormonal Parameters in Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097465
Enrollment
150
Registered
2025-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Arm 1: Intervention: Structured Lifestyle and Dietary Modification with Yoga Participants in the intervention group will receive a structured lifestyle program consisting of individual
dietary and lifestyle counselling reinforced every 2 weeks. Control Intervention1: Arm 2: Comparator / Control: Participants in the control group will receive standard medical care for PCOS as per ins

Sponsors

Arogyamitra Foundation Care Multispeciality Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female, 18–35 years of age 2. Confirmed diagnosis of Polycystic Ovarian SYndrome (PCOS) by Rotterdam criteria (any two of the three: oligo/anovulation, hyperandrogenism, polycystic ovaries on ultrasound) 3. BMI between 18.5 and 35 kg/m² 4. Not currently receiving hormonal treatments or insulin sensitizers for at least three months

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Proportion of participants achieving at least two consecutive regular menstrual or ovulatory cycles (mid-luteal progesterone 3 ng/mL) at 12 weeks, comparing the Intervention Arm (Yoga + Structured Lifestyle/Diet) vs Control Arm (Yoga + Routine Advice).Timepoint: 12 weeks—

Secondary

MeasureTime frame
Change from baseline to weeks 12 & 24 in the Metabolic Composite Score, defined as the mean of standardized z-scores of BMI, waist-to-hip ratio, & HOMA-IR (each standardized using the study baseline mean & SD). All component measures will be oriented such that higher scores indicate worse metabolic status; thus a decrease in the Metabolic Composite Score represents improvement. The Metabolic Composite Score will be analyzed using a linear mixed-effects model with fixed effects for treatment, visit (12, 24), baseline value, & a random intercept for participant.Timepoint: Week 12 & 24—

Countries

India

Contacts

Public ContactDeepti Girwalkar

Care multi-speciality hospital

deeptibokhare@gmail.com9665665555

Outcome results

None listed

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