Effect of Mangifera Indica leaves on metabolic health, anthropometric indices and sexual hormone levels in Polycystic Ovarian Syndrome or Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- This study shall provide an insight into the effectiveness of Mangifera indica leaves in the management and treatment of PCOS/PCOD, which shall pave the way for an alternative or adjunctive treatment to standardized management. There is a possibility of an assurance of new, cheaper, and efficient treatment modalities to be redefined in women afflicted with this endocrine and complication-involving disorder.
研究概览
简要总结
The study evaluates their effectiveness in improving metabolic health, anthropometric indices, and sexual hormone levels in women with PCOS. It integrates molecular insights into metabolic dysfunction, reproductive genetics, and cell biology. The research is structured as a funded study, incorporating literature reviews and a scientific approach to validate the therapeutic potential of mango leaves in addressing PCOS-related health concerns.The objectives include investigating their impact on insulin resistance, lipid profiles, blood sugar level, BMI and key reproductive hormones such as LH, FSH, and androgens etc. The methodology involves a clinical study with mango leaf supplementation, where participants will undergo pre- and post-intervention assessments of metabolic and hormonal parameters. Biochemical analyses and statistical evaluations will determine the efficacy of the intervention. Through molecular and clinical insights, this study seeks to validate the therapeutic potential of mango leaves as a nutraceutical intervention for PCOS, offering a natural, evidence-based approach for metabolic and endocrine regulation in affected women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •The inclusion criteria will be as follows:
- •Diagnosis of PCOS [Hrishikesh M, Madhuri P, Laxmi P, Advisors S, Gupte S, Divakar H, et al.
- •FOGSI-ICOG Good Clinical Practice Recommendations GCPR on Update in Managing PCOS in Women.
- •2024.] In adult women, the diagnosis of PCOS will be made using the Rotterdam criteria, meeting two of the following three conditions: (Grade A, EL 4) i) Androgen Excess [ Biochemical: serum total testosterone Clinical: persistent acne, Hirsutism, female pattern baldness] ii) Ovulatory dysfunction( Oligo or anovulatory cycles) iii) Polycystic Ovarian morphology on Ultrasonography
- •Presentation of acanthosis nigricans with or without obesity is an additional diagnostic criterion for PCOS in adults and adolescents (Grade B, EL 4).
- •Mild prolactinemia and subclinical hypothyroidism are common in PCOS; prolactin, TSH levels will also be taken in consideration (Grade B, EL 4)[22]
- •Age 20 to 25 years old.
- •Willingness to wait till the study duration and then commence any allopathic treatment of PCOS/PCOD.
- •Willingness to provide written Informed consent.
排除标准
- •Menopause
- •Thyroid disorders
- •Use of hormonal medications for treating menstrual abnormalities over the previous three months.
- •Hyperlipidemia [high-density lipoprotein (HDL) < 50 mg/dL (1.3 mmol/L), low-density lipoprotein (LDL) > 100 mg/dl, and triglycerides (TG) > 150 mg/dl, total cholesterol (TC) > 240 mg/dL(6.21 mmol/L)]
- •Hyperprolactinemia
- •Alterations in physical activity levels over the past 6 months
- •Presently on any medications, including antihyperglycemic agents, lipid-lowering medications, contraceptives, corticosteroids, or any other supplements.
- •Pregnant and lactating women.
- •History of allergic reactions to Mangifera indica.
结局指标
主要结局
This study shall provide an insight into the effectiveness of Mangifera indica leaves in the management and treatment of PCOS/PCOD, which shall pave the way for an alternative or adjunctive treatment to standardized management. There is a possibility of an assurance of new, cheaper, and efficient treatment modalities to be redefined in women afflicted with this endocrine and complication-involving disorder.
时间窗: 8 week intervention
次要结局
- It will provide a framework for future studies on herbal intervention in the management of PCOS/PCOD.
研究者
Dr Ashwini Patil
Symbiosis Medical College for Women