Health Condition 1: - Health Condition 2: E889- Metabolic disorder, unspecified
Conditions
Interventions
Intervention1: Ovydose plus Metformin: 400mg Ovydose@ /1000 mg Metformin/ once a day/oral administration/ 1 year
Control Intervention1: Metformin: 1000 mg/Once a day/Oral administration/1 year
Sponsors
Immunity Bloom ,Health Divison, Saveer Biotech Limited.
Eligibility
Inclusion criteria
Inclusion criteria: 1. The study will include PCOS women aged 18-45 years who had a confirmed diagnosis of PCOS based on the Rotterdam 2003 criteria. 2. Participants with a body mass index (BMI) ranging from 25 to 30 kg/m² will be included in the study. 3. PCOS Women with no history of type 2 diabetes mellitus, liver or kidney disease, or other severe illnesses will be eligible for participation. 4. The study will exclude PCOS women who were using oral contraceptives or other medications that could impact insulin resistance and/or menstrual irregularities.
Exclusion criteria
Exclusion criteria: 1. PCOS Women with history of Type 2 DM (diabetes mellitus) will be excluded from the study. 2. Pregnant PCOS women will be excluded from participation in the study 3. PCOS Women with infections, immunological diseases, malignancies, and other hormonal disorders such as deranged PRL (prolactin), TSH (thyroid-stimulating hormone), and 17-OHP (17-hydroxyprogesterone) will be excluded from the study. 4.PCOS Women with known cardiac or peripheral vascular diseases will be excluded from the study. 5.PCOS Women who were on insulin therapy will be exempted from participation in the study. 6. PCOS Women with impaired hepatic or renal function will be excluded from the study. 7. Those PCOS women who were taking ginseng or other herbs for diabetes will be excluded from the study. 8. Participants who were already involved in any other investigational drug studies will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Endpoint 1.Menstrual irregularities 2.No of cycles per year 3.Blood Pressure. 4.Hirsutism (FG score) 5.Acne will be evaluated using a standardized scoring system.Timepoint: 0 month Fourth month Sixth month Eighth month Twelfth month | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormonal Endpoint 1. The levels of SHBG, LH, FSH, testosterone, estradiol, & prolactin will be measured at baseline and at 12 months. 2. Insulin resistance: HOMA-IR index will be calculated. Biochemical Endpoints 1. Glucose intolerance 2. HBA1C 3. Lipid levels will be evaluated. Inflammatory Factors 1. IL-6 2.TNF-α Safety Indicators LFT & KFT Timepoint: 0 month Fourth month Sixth month Eighth month Twelfth month | — |
Countries
India
Contacts
Public ContactDr Syed Douhath Yousuf
Sher-i-kashmir institute of medical sciences
Outcome results
None listed