A phase III controlled clinical trial comparing efficacy of OvydoseÂ® plus Metformin versus Metformin alone in management of Polycystic Ovary Syndrome (PCOS).

Immunity Bloom ,Health Divison, Saveer Biotech Limited.2 sites in 1 country200 target enrollmentStarted: December 8, 2023Last updated: January 8, 2023

Trial Snapshot

Phase: Phase 3
Status: Not yet recruiting
Sponsor
Enrollment: 200
Locations: 2
Primary Endpoint: Clinical Endpoint

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Not Applicable
Masking: Not Applicable

Eligibility Criteria

Ages: 18.00 Year(s) to 45.00 Year(s) (—)
Sex: Female

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/mÂ² 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
•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.