Effectiveness of an Ayurvedic Intervention on Insulin Resistance in Polycystic Ovarian Syndrome
Phase 2
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2023/06/053929
- Lead Sponsor
- Government Ayurveda College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All eligible subjects aged 18-38 years fulfilling Rotterdam’s criteria 2003 of Polycystic Ovarian Syndrome and diagnosed as IR based on HOMA -IR value >2 enrolled in stage 1 & those give informed consent
Exclusion Criteria
i.BMI < 18.5
ii.Known cases of DM
iii.Hyperprolactinemia
iv.Uncontrolled thyroid disorders
v.Concurrent or previous use of insulin sensitising drugs within last three months
vi.Concurrent or previous use of oral contraceptive pills within last 3 months
vii.Renal dysfunction
viii.Hepatic dysfunction
ix.Pregnant ladies
x.Lactating mothers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in HOMA-IR at end-lineTimepoint: Differences in HOMA-IR at end-line 90th and 180th day
- Secondary Outcome Measures
Name Time Method Changes in Interval of menstrual cycle- assessed by direct interviewTimepoint: Changes in Interval of menstrual cycle- assessed by direct interview at 90th and 180th day;Changes in the number of follicular cysts-USG abdomenTimepoint: Changes in the number of follicular cysts-USG abdomen at end line 90th and 180th day;Changes in Waist to hip ratio calculated after measuring waist and hip using a standard measuring tape at end-lineTimepoint: Changes in Waist to hip ratio calculated after measuring waist and hip using a standard at end line 90th and 180th day