Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
Jinnah Postgraduate Medical Centre
116 participants
Feb 22, 2025
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
Inclusion Criteria3
- 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.
Exclusion Criteria13
- Pregnant or lactating women.
- Subjects with known Cushing's syndrome.
- Subjects with late-onset congenital adrenal hyperplasia.
- Subjects with androgen-secreting tumors.
- Subjects with uncontrolled thyroid disease.
- Subjects with hyperprolactinemia.
- Subjects with diabetes mellitus.
- Subjects with uncontrolled hypertension.
- Subjects with other cardiovascular diseases.
- Subjects with acute or chronic infections.
- Subjects with any known malignancy.
- Subjects with impaired renal function (serum creatinine \> 1.5 × ULN).
- Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).
Interventions
Herbal Formulation 500mg twice daily for 4 months in PCOS patients
Metformin XR 750mg twice daily for 4 months in PCOS patients
Herbal formulation and Metformin twice daily for 4 months in PCOS patients
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07399535