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

Jinnah Postgraduate Medical Centre

Status and phase: Enrolling; Phase 1

Conditions: Infertility; Herbal Medicine; Metabolic Disorder; Polycystic Ovarian Syndrome (PCOS)

Treatments: Drug: Metformin XR; Drug: Herbal Formulation; Drug: Metformin 750 mg and herbal formulation 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07399535

NO.F.2-81/2024-GENL/101/JPMC (Other Identifier)

Details and patient eligibility

About

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.

Full description

Polycystic Ovarian Syndrome is a point of concern these days in female population around the world.The patients feel psychological and mentally unhealthy. PCO effects around 6- 14% of women worldwide. PCOS is characterized by hormonal dis-regulation and hyperinsulinemia. Improvements in sex hormones and insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS Commonly prescribed treatment for PCOS include oral contraceptives (OCPs), metformin, pioglitazone, estrogen, GnRH agonist, myo-inositol, letrozole and clomiphene citrate. Despite their effectiveness in symptom relief and ovulation induction, these treatments are associated with adverse effects including weight gain, cardiac issues, lactic acidosis, dysmenorrhea, and abdominal discomfort (Hussain et al., 2022). Given the limitations of conventional drugs, Herbal therapies are gaining attention for their multi-targeted ability to restore natural hormonal balance, improve ovulation and offer symptom relief with minimal side effects (Hussain et al., 2022). In this context, the present study is designed to explore the therapeutic benefits of a novel polyherbal formulation that includes Momordica charantia L., Linum usitatissimum, Symplocos racemose bark, Allium cepa L., Tribulus terrestris, and eggshell. These ingredients were selected based on their various pharmacological properties that are relevant to the pathophysiology of PCOS. This study will evaluate the safety and effectiveness of Melats P in achieving a successful menstruation regulation in PCOS women.We will recruit 3 groups , First group with conventional treatment (Metformin ) , Second with Alternative medicine having a herbal Formulation ( Melats P) and Third group patients will receive both Conventional (Metformin) and Herbal Formulationn (Melats P).

Enrollment: 116 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Herbal formulation treated group

Experimental group

Description:

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

Treatment:

Drug: Herbal Formulation

Metformin XR treated group

Active Comparator group

Description:

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

Treatment:

Drug: Metformin XR

Adjunct Group

Experimental group

Description:

Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient

Treatment:

Drug: Metformin 750 mg and herbal formulation 500 mg