A Randomized Controlled Clinical Study of Yastimadhu Siddha Ghrita Pratimarsha Nasya on 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
- 63
- 试验地点
- 1
- 主要终点
- TFBUT test value to increase by 2-3 secs. Schirmer-I test value to increase by 1-2 units (1mm-2mm)
研究概览
简要总结
A randomized controlled clinical study of yastimadhu siddha ghrita pratimarsha nasya will be done on 63 patients presenting with complaints of Dry eye disease and they will be divided into 3 groups (A, B & C) . Group A will be provided with the trial drug, yastimadhu siddha ghrita and will be advised to instill 2 drops in each nostril every morning for 15 days. Group C will be provided with the control drug, Carboxymethylcellulose 0.5% eyedrop and will be advised to instill one drop three times a day for 15 days. Group B will be provided with both the drugs and will be advised the same. Study will be conducted for 28 days and all observations will be taken & recorded starting from 0th day and follow up will be done on 7th and14th day & on the 28th day observations will be taken for any recurrences. Data recorded will be analized 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
- 10.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •patients suffering from mild to moderate symptoms of dry eye disease who are willing to participate in the study will be selected.
排除标准
- •Patients showing severe symptoms of dry eye, any ocular surface pathology, any acute nasal pathology, having congenital anomalies of eye, who are one eyed patient and those whose age are below 10 yrs and above 45 yrs will be excluded.
结局指标
主要结局
TFBUT test value to increase by 2-3 secs. Schirmer-I test value to increase by 1-2 units (1mm-2mm)
时间窗: 28 days study with 3 follow up (7th day,14th day & 28th day)
次要结局
- Reduction of dryness, redness or congestion, itching, burning sensation & eye fatigue.(28 days study with 3 follow up (7th day,14th day & 28th day))