A Randomized open label clinical trial to evaluate the efficacy of Yashtimadhu ghrita Aschyothana and Anutaila Prathimarsha Nasya in Shushkakshipaka with special reference to Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters
研究概览
简要总结
This study is a randomized, controlled clinical trial in which 50 patients are selected as per the inclusion criteria and will be randomly divided into 2 groups .Treatment group will be given the Ayurvedic intervention ( Aschyothana with Yashtimadhu ghrita 2 drops BD and Prathimarsha nasya with Anutaila 2 drops morning ) and the other group will be given Carboxymethyl cellulose 1 % eyedrops 4 times a day for 30 days for comparing the efficacy of these drugs in Shushkakshipaka with special reference to Dry Eye Disease . The result will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients presenting with signs and symptoms of Dry eye Disease.
- •2.TBUT smaller than or equal to 5 seconds.
- •3.Schirmers test smaller than or equal to 10 mm.
排除标准
- •Cases complicated with acute, chronic, infective conjunctivitis or any specific eyelid disorder, corneal ulcer, dacryocystitis and lagophthalmos.
- •Contact lenses use.
- •History of ocular surgery within 6 months prior to enrolment in trial.
- •Pregnancy or child bearing age without contraception.
- •Patient who starts developing complications will be excluded from the study.
- •Patient not willing for the treatment.
- •Ongoing ocular or systemic infection.
- •Ocular or periocular malignancy.
- •Lid structural abnormality.
结局指标
主要结局
Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters
时间窗: Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters | Change in Tear Film Break-up Time(TFBUT) | Assessed at 15th day,30th day and 45th day
Change in Tear Film Break-up Time(TFBUT)
时间窗: Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters | Change in Tear Film Break-up Time(TFBUT) | Assessed at 15th day,30th day and 45th day
次要结局
未报告次要终点
研究者
Athira P
Banaras Hindu University