Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: PCOS diagnosis by a gynaecologist for the first time or in the last 6 month but have not undergone therapy (Drug or Lifestyle Intervention) of any kind.
Exclusion criteria
Exclusion criteria: Pregnant and Lactating Women. Women on hormonal or insulin sensitizing therapy. Women following a weight management program with diet and exercise therapy. Women on weight management programs with pharmacotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure changes in Homeostatic Model Assessment for Insulin Resistance and Inflammatory markers.Timepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure changes in Free Androgen Index (FAI)Timepoint: Baseline & 12 weeks;Measure changes in PCOM (Polycystic Ovarian Morphology)- Follicle number & Ovarian VolumeTimepoint: Baseline & 12 weeks;Measure changes in Menstrual irregularities.Timepoint: Baseline & 12 weeks;Measure changes in Cardiometabolic parameters (HbA1c, Lipid Profile, Visceral Fat, Body Fat)Timepoint: Baseline & 12 weeks;Measure changes in Manifestations of Hyperandrogenism - Hirsutism, Acne, Acanthosis nigricansTimepoint: Baseline & 12 weeks | — |
Countries
India
Contacts
Research Innovation Consultancy and Collaboration Center (RICCC)