Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Regulation of Menstrual Cycle
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Herbal formulation treated group
Herbal formulation 500 mg twice daily for 4 months in PCOS patients
干预措施: Herbal Formulation (Drug)
Adjunct Group
Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient
干预措施: Metformin 750 mg and herbal formulation 500 mg (Drug)
Metformin XR treated group
Metformin XR 750 mg twice daily for 4 months in PCOS patients
干预措施: Metformin XR (Drug)
结局指标
主要结局
Regulation of Menstrual Cycle
时间窗: Baseline to 4 months
Improvement and restoration of regular ovulatory menstrual cycles ( cycle length 21-35 days) after 4 months of treatment, assessed through menstrual history and ultrasonographic confirmation of ovulation. Ovulation confirmed by transvaginal ultrasonography, defined by the presence of a dominant follicle followed by follicular rupture during the treatment period.
次要结局
- Serum Follicle-Stimulating Hormone (FSH) Levels(Baseline and after 4 months)
- Serum Luteinizing Hormone (LH) Levels(Baseline and after 4 months)
- Serum Testosterone Levels(Baseline and after 4 months)
- Glycated Hemoglobin (HbA1c) Level(Baseline and after 4 months)
- Fasting Serum Insulin Concentration(Baseline and after 4 months)
- HOMA-IR(Before and after 4 months)
- Body Weight(Baseline and after 4 months)
研究者
Saba Zubair
Principal Investigator
Jinnah Postgraduate Medical Centre
