A comparative efficacy study of Nishamalaki and Metformin in women suffering from Polycystic Ovary syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.5% improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group
研究概览
简要总结
PCOS is the most common and complex endocrine disease affecting 5–10 % of women of reproductive age. The diagnosis of PCOS is based on the presence of at least two of the following three criteria: chronic anovulation, hyperandrogenism (clinical or biological), and polycystic ovaries, termed Rotterdam criteria. In this study, the herbal formulation Nishamlaki will be evaluated compared to Metformin in PCOS. Women in the age group of 18 - 45 years approaching the outpatient department of Gynecology and Obstetrics will be screened for presence of PCOS, through USG and blood investigations; TSH and HbA1c. Eligible women will be recruited and randomly allocated to either of the two intervention groups; Nishamlaki or Metformin. Further, anthropometry, body composition, Fasting glucose, Insulin, Lipid profile, Leutinizing hormone (LH), Follicle stimulating hormone (FSH), Dehydroepiandrosterone sulphate (DHEAS), Prakruti (body constitution) and quality of life (PCOS-QOL Questionnaire), will be done at baseline. The duration of the study will be 3 months and all above parameters except Prakruti and blood investigations will be done monthly. The blood investigations will be repeated at the end of the study. The study outcomes include; improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group, Number of participants showing improvement in menstrual cycles comparable in both Nishamlaki and Metformin groups, improvement in anthropometry and body composition in Nishamlaki group comparable to Metformin group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women in the age group of
- •45 years (both inclusive) with no conception 2.Women with the presence of any two of the three Rotterdam criteria: oligomenorrhoea, clinical hyperandrogenism, and polycystic ovarian morphology on ultra-sonography (USG) 3.Individuals willing to abide by the study-related procedures.
排除标准
- •1.Known history of severe hepatic, renal, or cardiac pathologies viz.
- •portal hypertension, nephropathy, oesophageal varices, myocardial infarction, stroke, arrythmia etc.
- •2.Known cases of active infections such as tuberculosis, HIV, or hepatitis B etc 3.Known history of congenital anomalies of genital tract, cervical pathologies such as polyp, Ca cervix, uterine pathologies such as fibroid, endometriosis 4.Known history of endocrinopathies such as hypothyroidism, hyperprolactinemia, Cushing’s Syndrome, adrenal tumor, ovarian tumor, and late-onset congenital adrenal hyperplasia 5.Women on anxiolytic, antipsychotic, and antidepressant drugs for the past 6 months 6.Any other conditions which in the opinion of investigator can place the patient at risk or can influence the conduct of study or interpretation of results.
结局指标
主要结局
1.5% improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group
时间窗: Baseline, day 30, day 60, day 90
2.Number of participants showing improvement in menstrual cycles comparable in both Nishamlaki and Metformin groups
时间窗: Baseline, day 30, day 60, day 90
3.5% improvement in anthropometry and body composition in Nishamlaki group comparable to Metformin group
时间窗: Baseline, day 30, day 60, day 90
次要结局
未报告次要终点
研究者
Dr Poonam Gupte
Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA