A Randomized Controlled Clinical Study Of Amalaki Siddha Ghrita Tarpana In Dry Eye Disease
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- TFBUT test value to increase by 2-3 secs.
研究概览
简要总结
A randomized controlled clinical study of amalaki siddha ghrita tarpana will be done on 42 patients presenting with complaints of Dry eye disease and they will be divided into 2 groups (A&B). Group A will be provided with the trial drug amalaki siddha ghrita in the form of tarpana everyday once in the morning for 7 days. Group B will be provided with the control drug carboxymethylcellulose 0.5% eyedrop and will be advised to instill one drop 3 times a day. Study will be conducted for 14 days and observations will be taken and recorded starting from 0th day and follow up will be done on 7th day and on 14th day observations will be taken for any recurrences.Data recorded will be analyzed statistically and conclusion will be drawn based on it.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •patients suffering from mild to moderate Dry eye disease who are willing to participate will be selected.
排除标准
- •patient with severe dry eye disease or any occular surface pathology or congenital anamolies of eye or one eyed patient or patient with eye lid disease or noncooperative patient.
结局指标
主要结局
TFBUT test value to increase by 2-3 secs.
时间窗: 7 days tarpana will be given,follow up will be on (7th and 14th day)
Schirmer-I test value to increase by 1-2 units (1mm-2mm)
时间窗: 7 days tarpana will be given,follow up will be on (7th and 14th day)
次要结局
- Reduction in the symptoms of Dryness, Eye fatigue, Redness, Burning sensation, Itching, Headache as compared to the standard drug mentioned in the subjective criteria(7 days tarpana will be given,follow up will be on (7th and 14th day))