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

Phase 3

Not yet recruiting

• Conditions: Metabolic disorder, unspecified,

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

Brief Summary

This study is a randomized, double-blind, parallel Group, multicentric trial comparing the safety and efficacy of Ovydose @ 400mg  plus  Metformin 1000mg  versus Metformin 1000mg   alone for 12 months in total of 200 patients (100 patients in each group) with PCOS. The study will be conducted at two centers (SKIMS and JVC). The primary outcome measures will include Clinical endpoints while the Secondary outcome measures will include biochemical and hormonal endpoints which will be recorded at 0 months,4th month, 6th month, 8th month, and 12th month of the trial.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-08
• Study Start: 2023-12-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• The study will include PCOS women aged 18-45 years who had a confirmed diagnosis of PCOS based on the Rotterdam 2003 criteria.
• Participants with a body mass index (BMI) ranging from 25 to 30 kg/m² will be included in the study.
• PCOS Women with no history of type 2 diabetes mellitus, liver or kidney disease, or other severe illnesses will be eligible for participation.
• 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

• PCOS Women with history of Type 2 DM (diabetes mellitus) will be excluded from the study.
• 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.
• PCOS Women with impaired hepatic or renal function will be excluded from the study.
• Those PCOS women who were taking ginseng or other herbs for diabetes will be excluded from the study.
• 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

Primary Outcome Measures

Name	Time	Method
Clinical Endpoint	0 month | Fourth month | Sixth month | Eighth month | Twelfth month
4.Hirsutism (FG score)	0 month | Fourth month | Sixth month | Eighth month | Twelfth month
1.Menstrual irregularities	0 month | Fourth month | Sixth month | Eighth month | Twelfth month
2.No of cycles per year	0 month | Fourth month | Sixth month | Eighth month | Twelfth month
3.Blood Pressure.	0 month | Fourth month | Sixth month | Eighth month | Twelfth month
5.Acne will be evaluated using a standardized scoring system.	0 month | Fourth month | Sixth month | Eighth month | Twelfth month

Secondary Outcome Measures

Name	Time	Method
Hormonal Endpoint	1.The levels of SHBG, LH, FSH, testosterone, estradiol, & prolactin will be measured at baseline and at 12 months.

Trial Locations

Locations (2)

Sher-i kashmir institute of medical sciences,Soura; 🇮🇳 JAMMU, & KASHMIR, India

SKIMS Medical college, [Jehlum valley medical College(JVC)]; 🇮🇳 JAMMU, & KASHMIR, India

Sher-i kashmir institute of medical sciences,Soura

🇮🇳JAMMU, & KASHMIR, India

Prof Mohammad Ashraf Ganie

Principal investigator

9419041546

ashraf.endo@gmail.com