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Comparison of two packages of behavioural interventions on the clinical outcome of polycystic ovarian disease in women

A Randomised controlled trial comparing two packages of behavioural interventions on the clinical outcome of polycystic ovarian disease in women attending tertiary care hospital. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110688
Enrollment
110
Registered
2026-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Behavioural intervention: Lifestyle modifications including dietary changes, yoga and exercise Control Intervention1: Self Instruction booklet and individualised training sessions: Comp

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Married women with Polycystic Ovarian disease fulfilling criteria for diagnosis based on Modified Rotterdam Consensus 2. Age 18 to 45 years 3. Body Mass Index of atleast 23 kg per meter square 4. Has not taken hormonal contraceptives for last three months 5. Women who are residents of Nahan and adjoining areas

Exclusion criteria

Exclusion criteria: 1. Women with Polycystic Ovarian disease who do not give consent 2. Pregnant or nursing women 3. Woman planning to be away for more than 4 weeks of the intervention period. 5. Suffering from chronic disease ((Diabetes Mellitus, hypertension, Bronchial asthma, Chronic kidney and Liver disease etc) 6. Uncontrolled Hypothyroidism (TSH greater than 10IU per ml),Cushing s syndrome,Congenital Adrenal Hyperplasia 7. On Anti depressants

Design outcomes

Primary

MeasureTime frame
1. Improvement in Menstrual Regularity- Assessment of score based on Visual Analogue Scale (VAS) 2. Enhancement in Health Related Quality of life- Assessment based on Health Related Quality of life (HRQOL) Polycystic Ovary Syndrome Questionnaire (PCOSQ) Timepoint: Monthly visits every month for a time period of 6 months

Secondary

MeasureTime frame
1. Reduction in Body Mass Index (BMI) and/or Waist-Hip Ratio - more than 3-5% reduction in Body Mass Index (BMI) and/or Waist-Hip Ratio Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Akshita Rohit Yadav

Department of Community Medicine Dr. Yashwant Singh Parmar Government Medical College Nahan district Sirmaur, Himachal Pradesh

1212akshita@gmail.com06398319238

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026