Comparative study of Amritadyaguggulu with Kanashatahwadi kashayam and Navaka guggulu with Chitrakagrandhyadi kashayam in the management of oligomenorrhoea among overweight women with PCOS.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Polycystic Ovarian Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, characterized by oligo/anovulation, hyperandrogenism and polycystic ovarian morphology on ultrasonography. The condition has significant reproductive, metabolic and psychological implications including infertility, irregular menstrual cycles, obesity, cardiovascular diseases, Type 2 diabetes mellitus and increased risk of endometrial carcinoma. The present study is to evaluate the effect of Amritadyaguggulu with Kanashatahwadi kashayam in comparison against Navakaguggulu with Chitrakagrandhyadi Kashaya in the management of oligomenorrhoea among overweight women with PCOS. Study design is an Interventional study- Comparative clinical trial with a targeted sample size of 30 participants in each group. Eligible female subjects aged 18-45 years, diagnosed with Polycystic Ovarian Syndrome are recruited from the Outpatient Department of Streeroga and Prasoothitantra at Government Ayurveda College Hospital, Tripunithura. Sampling method will be consecutive sampling. In 1st group Amritadyaguggulu 1 BD with Kanashatahwadi Kashayam 48 ml twice daily before food and in 2nd group Navakaguggulu 1 BD with Chitrakagrandhyadi Kashayam 48 ml twice daily before food is given for a study period of 90 days starting from the 1st day of visit excluding the days of menstruation. Assessment occurs on the first,31st,61st,91st and 121st days focusing on changes in BMI, changes in mean interval of menstrual cycles and waist circumference. Additionally, participants will undergo assessment on first and 91st day examining changes in ovarian morphology.
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
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Poly cystic ovarian syndrome patients diagnosed according to ESHRE/ASRM criteria
- •BMI greater than or equal to 25 to less than or equal to 35.
排除标准
- •Pregnancy and lactating mothers Patients with primary amenorrhoea Known case of uncontrolled diabetes and uncontrolled hypertension Known case of systemic illness like cardiovascular diseases, kidney, liver diseases Haemoglobin less than 7grampercentage Use of statins or other medicines known or suspected to affect reproductive or metabolic functions Known cases of Malignancy.
研究者
Sreelekshmi P S
Government Ayurveda College Tripunithura
