RecruitingPhase 1NCT07399535

Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome


Sponsor

Jinnah Postgraduate Medical Centre

Enrollment

116 participants

Start Date

Feb 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical investigation is testing an herbal formulation to see whether it can reduce insulin resistance (when the body doesn't respond well to insulin) and other metabolic symptoms in women with polycystic ovary syndrome (PCOS) — a hormonal condition that affects periods, fertility, and metabolism. **You may be eligible if...** - You are a woman of reproductive age (18–40 years) - You have been diagnosed with PCOS by a clinician - You have insulin resistance (measured by HOMA-IR score above 2.00) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have Cushing's syndrome (a condition involving excess cortisol) - You have congenital adrenal hyperplasia (a genetic hormone disorder) - You are already on medications that would interfere with the herbal treatment - You have known allergies to the herbal ingredients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHerbal Formulation

Herbal Formulation 500mg twice daily for 4 months in PCOS patients

DRUGMetformin XR

Metformin XR 750mg twice daily for 4 months in PCOS patients

DRUGMetformin 750 mg and herbal formulation 500 mg

Herbal formulation and Metformin twice daily for 4 months in PCOS patients


Locations(1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07399535


Related Trials