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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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
Jinnah Postgraduate Medical Centre
Karachi, Sindh, Pakistan
Regulation of Menstrual Cycle
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.
Time frame: Baseline to 4 months
Serum Follicle-Stimulating Hormone (FSH) Levels
Change in serum follicle-stimulating hormone (FSH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 3.5 - 12.5 , Women (Ovulation Phase): 4.7 - 21.5, Women (Luteal Phase): 1.7 - 7.7
Time frame: Baseline and after 4 months
Serum Luteinizing Hormone (LH) Levels
Change in serum luteinizing hormone (LH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 1.9 - 9.2, Women (Ovulation Phase): 6.1 - 49.1, Women (Luteal Phase): 1.3 - 10.8
Time frame: Baseline and after 4 months
Serum Testosterone Levels
Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481
Time frame: Baseline and after 4 months
Glycated Hemoglobin (HbA1c) Level
Change in glycated hemoglobin (HbA1c) percentage measured using standardized laboratory methods. Unit of Measure: %, Normal Range: Normal \<5.6%, Prediabetes: 5.7% - 6.4%, Diabetes: 6.5% or higher
Time frame: Baseline and after 4 months
Fasting Serum Insulin Concentration
Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25
Time frame: Baseline and after 4 months
HOMA-IR
HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5.
Time frame: Before and after 4 months
Body Weight
Change in body weight measured using a calibrated weighing scale. Unit of Measure: kg
Time frame: Baseline and after 4 months
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