A Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Artava Janana Effect of kashmarya- kshudrasaha granules in vataja artava dushti W.S.R. to Oligo-hypomenorrhoea on the basis of Pictoral Blood Assessment Chart, artava srava swaroopa chart, artava srava kalaavdhi chart, duration between two artava darshana both before and after treatment.
研究概览
简要总结
This is a Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea.
70 patients selected according to inclusion criteria will be administered with kashmarya-kshudrasaha granules orally mixed with milk twice a day in a single dose of 1 karsha (10g) for 3 menstrual cycles.
The Primary outcome measures will be improvement in the amount of menstrual bleeding & reducing the inter-menstrual duration. This will be assessed by subjective parameters i.e. Artava srava swaroopa (Appearance of menstrual blood),Artavasrava Kalaavadhi (Duration of Menstrual Flow) & Duration of Artava darshan (Interval between two cycles) and subjective parameter i.e. by comparing the changes in Pictorial Blood Chart before and after treatment. The total duration of the study is 18 months.
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
- 13.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢All female patients in the Age group of 13-19 years who are willing to participate in the study who are having symptoms of vataja artava dushti.
- •â€¢With symptoms of oligo-hypomenorrhea i.e. inter-menstrual duration more than 35 days and menstrual bleeding flow less than 2 days.
- •â€¢Female patients irrespective of caste, education, income group and any occupation will be selected.
- •â€¢Hemoglobin 9 g % and above.
- •â€¢BMI – 18-27.
排除标准
- •â€¢K/C/O of any major systemic diseases.
- •â€¢K/H/O of Mullerian Duct Anomalies.
- •â€¢Intermenstrual duration more than 60 days.
结局指标
主要结局
Artava Janana Effect of kashmarya- kshudrasaha granules in vataja artava dushti W.S.R. to Oligo-hypomenorrhoea on the basis of Pictoral Blood Assessment Chart, artava srava swaroopa chart, artava srava kalaavdhi chart, duration between two artava darshana both before and after treatment.
时间窗: 3 menstrual cycles
次要结局
- Improvement in Vataja artava dushti condition i.e. improving the amount of menstrual bleeding & reducing the inter-menstrual duration.(3 menstrual cycles)
研究者
Meghna Vaman Nayak
Yashwant Ayurvedic College, Post Graduate Training and Research Centre