Comparison between effect of Nishamalaki and Metformin in women suffering from Polycystic Ovary syndrome (PCOS)

Not Applicable

Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

Registration Number: CTRI/2024/05/066871

Lead Sponsor: Shree Dhootpapeshwar Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Women in the age group of 18 - 45 years (both inclusive) with no conception

2.Women with the presence of any two of the three Rotterdam criteria: oligomenorrhoea, clinical hyperandrogenism, and polycystic ovarian morphology on ultra-sonography (USG)

3.Individuals willing to abide by the study-related procedures

Exclusion Criteria

1.Known history of severe hepatic, renal, or cardiac pathologies viz. portal hypertension, nephropathy, oesophageal varices, myocardial infarction, stroke, arrythmia etc.

2.Known cases of active infections such as tuberculosis, HIV, or hepatitis B etc

3.Known history of congenital anomalies of genital tract, cervical pathologies such as polyp, Ca cervix, uterine pathologies such as fibroid, endometriosis

4.Known history of endocrinopathies such as hypothyroidism, hyperprolactinemia, Cushing’s Syndrome, adrenal tumor, ovarian tumor, and late-onset congenital adrenal hyperplasia

5.Women on anxiolytic, antipsychotic, and antidepressant drugs for the past 6 months

6.Any other conditions which in the opinion of investigator can place the patient at risk or can influence the conduct of study or interpretation of results

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.5% improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group <br/ ><br> <br/ ><br>2.Number of participants showing improvement in menstrual cycles comparable in both Nishamlaki and Metformin groups <br/ ><br> <br/ ><br>3.5% improvement in anthropometry and body composition in Nishamlaki group comparable to Metformin group <br/ ><br>Timepoint: Baseline, day 30, day 60, day 90

Secondary Outcome Measures