Role of kutajashtaka avaleha and yashtimadhu ghrita matra basti in the management of asrigdara.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in the cases of asrigdara.
研究概览
简要总结
This study is a randomised , open label, parallel group trial to evaluate the clinical efficacy of Kutajashtaka avaleha orally regularly for the period of 3 months with the doses of 5 gm twice a day after meal with water and combination of Kutajashtaka avaleha and Yashtimadhu ghrita matra basti ( 60 ml for 7 days in three consecutive cycles after meal through rectal route after 7th day of menses ) for 3 months for treating heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of asrigdara. The study will be conducted in All India Institute of Ayurveda, Sarita Vihar, New Delhi. Primary outcome of the study will be reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of Asrigdara and secondary outcome will be to assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •patients with symptoms of heavy and prolonged menstrual bleeding or intermenstrual bleeding.
- •Patients who are interested and ready to give their written consent for the study work.
- •patients who are willing to go for relevant investigations.
排除标准
- •Any diagnosed uterine organic pathology like uterine fibroid, adenomyosis, chronic tubo-ovarian mass.
- •systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
- •coagulopathy, liver and thyroid dysfunction.
- •malignancy or undiagnosed neoplasm.
- •history of recent abortion.
- •active genital tuberculosis.
- •bleeding from the polyp and erosion.
- •Hb less than 8 gm/dl.
- •chronic constipation.
结局指标
主要结局
reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in the cases of asrigdara.
时间窗: 4 months
次要结局
- To assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.(4 months)