A Randomised Controlled Clinical Study to Evaluate the Efficacy of Katakadi Anjana and Carboxymethylcellulose Eye Drops in Dry Eye Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of Katakadi Anjana on both eyes in the dose of 2 mg in each eye in the management of dry eye syndrome for 7 days on the Tear Film Break Up Time (TBUT)test.
研究概览
简要总结
Dry eye syndrome is a multifactorial disease of the ocular system. It is a result of unstable tear film, causing ocular surface inflammation and damage. At present, there is no cure for Dry Eye Syndrome. Lubricating eye drops are used to reduce the symptoms but after prolonged use may develop resistance. Ayurveda has described shushkakshipaka which can be considered as a correlation of dry eye syndrome. The Anjana that will be used in this study is said to be Prasadajanak i.e. providing lubrication to the eye.
Literature include anjanakarma. Drugs have chakshushya property along with vata shamana.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients showing minimum 3 signs and symptoms of dry eye syndrome like burning sensation, foreign body sensation, redness, blurring of vision, ocular fatigue, excessive blinking.
- •Patients fit for anjana karma.
排除标准
- •Known case of any congenital anomalies of the eye.
- •Any acute infective condition of the eye.
- •Severe dry eye with corneal involvement.
结局指标
主要结局
1. To evaluate the efficacy of Katakadi Anjana on both eyes in the dose of 2 mg in each eye in the management of dry eye syndrome for 7 days on the Tear Film Break Up Time (TBUT)test.
时间窗: 7 days of study with 2 follows on the 4th and 7th day
次要结局
- To study the adverse drug effects if any(7 days of study with 2 follows on the 4th and 7th day)