Herbal Medicine, Infertility, Metabolic Disorder, Polycystic Ovarian Syndrome (PCOS)
Conditions
Keywords
polycystic ovarian syndrome, herbal formulation, infertility
Brief 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.
Detailed 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).
Interventions
Herbal Formulation 500mg twice daily for 4 months in PCOS patients
DRUGMetformin XR
Metformin XR 750mg twice daily for 4 months in PCOS patients
Herbal formulation and Metformin twice daily for 4 months in PCOS patients
Sponsors
Jinnah Postgraduate Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regulation of Menstrual Cycle | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Follicle-Stimulating Hormone (FSH) Levels | Baseline and after 4 months | 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 |
| Serum Luteinizing Hormone (LH) Levels | Baseline and after 4 months | 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 |
| Serum Testosterone Levels | Baseline and after 4 months | Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481 |
| Glycated Hemoglobin (HbA1c) Level | Baseline and after 4 months | 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 |
| Fasting Serum Insulin Concentration | Baseline and after 4 months | Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25 |
| HOMA-IR | Before and after 4 months | 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. |
| Body Weight | Baseline and after 4 months | Change in body weight measured using a calibrated weighing scale. Unit of Measure: kg |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORSaba Zubair, PhD scholar
University of Sindh Jamshoro
Outcome results
None listed