Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Spironolactone: Spironolactone 25 mg once day for 12 weeks with Metformin 1000 mg once daily for 12 weeks
Control Intervention1: Metformin: 1000 mg once daily for 12 weeks
Sponsors
Government Doon Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Serum total testosterone above the normal reference range for age and lab-specific cut-off. Evidence of insulin resistance (HOMA-IR greater than 2.5, or Fasting insulin greater than 15 IU/mL BMI between 18.5 and 35 kg/m . Willing to comply with procedures and provide informed consent
Exclusion criteria
Exclusion criteria: Pregnant or lactating females, or Women of Reproductive Age wanting to conceive in the next 4 months Impaired serum prolactin and thyroid function Other established endocrine diseases (like Cushing syndrome, Congenital adrenal hyperplasia) and Metabolic Syndrome (defined as 3 or more of the following; waist circumference greater than 88 cm, blood pressure greater than 130/85 mm Hg, triglycerides level greater than 150 mg/dL, high-density lipoprotein cholesterol level less than 50 mg/dL, or blood glucose fasting greater than 100 mg/dL.) Diabetes Mellitus, liver or renal dysfunction Patient on drugs including oral contraceptives, anti-hypertensive agents, anti-diabetic agents, anti-depressants and agents for weight loss that affect the metabolism of glycolipids and sex hormones in the past 3 months. Patients unwilling to participate or unwilling to give written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| More than or equal to 15% reduction in serum total testosterone levels from baseline at 12 weeks in the combination therapy group (Spironolactone + Metformin), compared to the metformin group. More than or equal to 2-point reduction in modified Ferriman Gallwey (mFG) score from baseline at 12 weeks, indicating clinical improvement in hirsutism. At least one spontaneous menstrual cycle within the 12-week period (i.e., return of ovulatory function). More than or equal to 10% reduction in fasting insulin and/or more than or equal to 0.5-unit reduction in HOMA-IR from baseline, suggesting improved insulin sensitivityTimepoint: Baseline, 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| More than or equal to 1 kg/m reduction in BMI from baseline to week 12, indicating a favourable metabolic trend More than or equal to 10% improvement in lipid profile parameters, defined as: Decrease in total cholesterol and LDL by at least 10% Increase in HDL by at least 5% Decrease in triglycerides by at least 10% More than or equal to 20% reduction in serum CRP levels from baseline, indicating anti-inflammatory benefit.Timepoint: Baseline, 6 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rangeel Singh Raina
Government Doon Medical College
Outcome results
None listed