CTRI/2023/10/058721尚未招募3 期
A CONTROLLED CLINICAL TRIAL TO EVALUATE THEEFFECT OF PATHYADI KWATHA IN ASRIGDARA W.S.R. TODYSFUNCTIONAL UTERINE BLEEDING
Dr Komal T Gayakwad1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of trial drug on improvement in the symptoms of Asrigdara(DUB).
研究概览
简要总结
- Asrigdarais one among the Raktapradoshaja vikara& is characterized by Artava atipravrutti,Deerghakala pravrutti,Anruta kala pravrutti associated with Angamardand Savedana Artava pravrutti.
- It is similar to Dysfunctional Uterine Bleeding (DUB), characterized by excessive bleeding without any known pelvic pathology
- In this study Pathyadi Kwatha is selected as trial drug for the management of Asrigdara(DUB) and its efficacy is compared with Dhataki-Puga Pushpa Kwatha.
- This is a randomized controlled clinical trial. Total 40 patient of Asrigdara who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Asrigdara will be selected
- Total Study duration will be 90 days and contain 6 visits (every 4th and 10th day of 3 comsecutive menstrual cycle), which includes administration of trial drug for 7days for two consecutive cycle and post medication follow up on 4th and 10th day of 3rd menstrual cycle.
- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pratyatma lakshana of Asrigdara and DUB.
- •Asrigdara-Artava deergha kala Pravritti, Artava Ati Pravritti, Anruta kala Pravritti.
排除标准
- •1.K/C/O – Diabetes mellitus, hypertension, tuberculosis.
- •2.Patient using intra uterine contraceptive device 3.K/C/O-Coagulation disorders 4.Patient with severe anemia HB% below 8 gms 5.K/C/O- Any pelvic pathology.
结局指标
主要结局
Effect of trial drug on improvement in the symptoms of Asrigdara(DUB).
时间窗: 4th day of menses, 10th day for three consecutive cycle
次要结局
- Safety of the trial drug & Adverse Drug reaction & Aggravation in the symptoms of Asrigdara(DUB)(4th day of menses, 10th day for three consecutive cycle)
研究者
研究点 (1)
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