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

A comparative efficacy study of Nishamalaki and Metformin in women suffering from Polycystic Ovary syndrome (PCOS) - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066871
Enrollment
30
Registered
2024-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

None listed

Sponsors

Shree Dhootpapeshwar Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
NoneTimepoint: NA

Countries

India

Contacts

Public ContactDr Girija Wagh

Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA

poonam.gupte@bharatividyapeeth.edu02024366920

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026