Effect of Varaasanadi kwatha and Vidanganagaradi churna in reducing Body Mass Index (BMI) of Poly Cystic Ovarian Syndrome patients.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate the effect of varaasanadi kwatha and vidanganagaradi choorna in reducing Body Mass Index of PCOS patients
研究概览
简要总结
Polycystic Ovarian Syndrome (PCOS) is a prevalent endocrine disorder affecting women of reproductive age, characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. It presents with short-term consequences including infertility, irregular menstrual cycles, obesity, and metabolic disturbances, with long-term risks including cardiovascular diseases and Type 2 diabetes mellitus. Management strategies predominantly involve weight loss interventions alongside pharmacological treatments. This clinical trial proposes the evaluation of traditional Ayurvedic formulations, Varaasanadi Kwatha and Vidanganagaradi Choorna, for their efficacy in managing PCOS. These formulations, are predominantly Kaphamedohara , Katu Tiktha Kashaya rasa pradhana Tikshna guna ,ushna virya and katu vipaka . hold promise in acting as both Sthoulyahara and Arthavapravarthaka. Study design is an Interventional pre- and post-study with a targeted sample size of 28 participants. Eligible female subjects aged 18-45 years, diagnosed with Polycystic Ovarian Syndrome, are recruited from the Outpatient Department of Prasutitantra and Streeroga at the Government Ayurveda College Hospital in Tripunithura. Data collection involves clinical observation using a structured case proforma and conducting relevant investigations. The intervention includes administering 48 ml of Varaasanadi Kwatha twice daily before meals and 6 grams of Vidanganagaradi Choorna with 6 grams of honey as anupana twice daily before meals over a 90-day period. Assessment occurs on the 0th and 91st days, focusing on changes in Body Mass Index, Waist Circumference, ovarian morphology via ultrasound, and PBAC (Pictorial Blood Assessment Chart) score, which evaluates menstrual cycle characteristics. Additionally, participants undergo reviews on the 31st and 61st days, primarily examining changes in Body Mass Index, Waist Circumference, and PBAC score.
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
- •Female patients within age group 18-45 years attending outpatient department of government ayurveda college Tripunithura who are willing to give written consent Poly Cystic Ovarian Syndrome patients diagnosed according to ESHRE ASRM criteria 2018 BMI greater than or equal to 25 kg per m2.
排除标准
- •Pregnancy and lactating mothers ,patient with heavy menstrual bleeding and prolonged spotting ,known case of uncontrolled diabetes and uncontrolled hypertension ,known case of systemic illness like cardiovascular diseases ,kidney ,liver diseases,hemoglobin less than 7 gm percentage,use of statins or other medicines known or suspected to affect reproductive or metabolic functions,known case of malignancy.
结局指标
主要结局
To evaluate the effect of varaasanadi kwatha and vidanganagaradi choorna in reducing Body Mass Index of PCOS patients
时间窗: after 90 days
次要结局
- waist circumference characteritics of menstrual cycle nature size or volume of ovary(after 90 days)
研究者
Sreelakshmi CC
Government Ayurveda College Tripunithura
