Randomized controlled clinical trial of Draksha Siddha Ghrita Aschyotana and CarboxyMethyl Cellulose 0.5% eye drops in the management of Shushkakshipaka.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A Clinical study to evaluate efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t Dry eye. parameter of efficacy is Schirmers test before and after treatment
研究概览
简要总结
This study is open Labelled randomised comparative clinical trial to evaluate the effect of Draksha Siddha Ghrita Aschyotana twice a day for 21 days in comparison with Carboxy Methyl Cellulose 0.5% eye drops twice a day for 21 days in patients affected with shushkakshipaka w.r.t. Dry eye . The primary outcome will be effect of DrakshaSiddha Ghrita Aschyotana and the secondary outcome will be a comparison between trail drug and controlled drug in the management of Shushkakshipaka w.r.t. Dry eye
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from symptoms of Shushkakshipaka.
- •Age -19-65yrs.
- •Irrespective of Either gender.
- •Only those cases will be accepted for final assessment that successfully complete the treatment in given time.
排除标准
- •Patients having complicated eye diseases or any severe occular infections like corneal ulcer etc.
- •Patients not ready for drug trial & follow up.
- •Patient having autoimmune disorders like RA, Sjogrens syndrome or any systemic diseases like Diabetic Mellitus, Hypertension.
结局指标
主要结局
A Clinical study to evaluate efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t Dry eye. parameter of efficacy is Schirmers test before and after treatment
时间窗: The drug will be given 21 days . the patient will be assessed before and after treatment . Total duration of study will be 18 months
次要结局
- Comparison between efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t. dry eye(18 months)