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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Female subjects of reproductive age (18-40 years).

• Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria.

• Subjects with insulin resistance defined as HOMA-IR \> 2.00.

Locations
Other Locations
Pakistan
Jinnah Postgraduate Medical Centre
RECRUITING
Karachi
Contact Information
Primary
Saba Zubair, PhD Scholar
saba.zubair1@gmail.com
+923313613089
Time Frame
Start Date: 2025-02-22
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 116
Treatments
Experimental: Herbal formulation treated group
Herbal formulation 500 mg twice daily for 4 months in PCOS patients
Active_comparator: Metformin XR treated group
Metformin XR 750 mg twice daily for 4 months in PCOS patients
Experimental: Adjunct Group
Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient
Sponsors
Leads: Jinnah Postgraduate Medical Centre

This content was sourced from clinicaltrials.gov