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

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.

Sex

Female

Minimum age

18 Years

Maximum age

40 Years

Inclusion Criteria:

* 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 Criteria:

* 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).

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