A study to compare how well Ovydose® combined with Metformin works compared to Metformin alone for treating Polycystic Ovary Syndrome (PCOS).

Phase 3

• Conditions: Health Condition 1: - Health Condition 2: E889- Metabolic disorder, unspecified

• Registration Number: CTRI/2023/08/055997
• Lead Sponsor: Immunity Bloom ,Health Divison, Saveer Biotech Limited.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified