Evaluation of anti-Cataract activity of NIF herbal medication [Eye drop] in Senile Immature Cataract condition.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Medicine will likely delay or arrest the progression of senile immature cataract.
研究概览
简要总结
The present study will be undertaken for evaluation of NIF herbal medication by conducting clinical trials in senile immature cataract patients. It is known that diabetes also contributes in the maturity of cataract, the present clinical study will be exclusively conducted on non-diabetic patients. This will be based on investigation of HbA1c having value less than 6.5 for individuals with senile immature cataract. As no proven medicine is available for cataract, control group patients will be given commercial lubricating eye drop. This clinical trial will include 100 cataract eyes ofSenile Immature Cataract which will randomly divided into 2 groups viz., Test Group I and Test Group II [Trial Group for Test medication include 75 cataract eyes and Control group for Commercially available lubricating drop include 25 cataract eyes]. In case patients having both eyes affected with senile immature cataract, those will be considered as two samples and data will be organized accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The inclusion criteria is to have patients with age Group 60 years and above either gender diagnosed with Senile immature Cataract.
排除标准
- •The exclusion criteria for the research program viz., Cataracts other than senile immature cataract; History of any Systemic diseases; If HbA1C more than 6.5; Patients having Glaucoma; Corneal ulcer, Dacryocystitis or any type of Ocular surface or retinal pathology will be excluded, Sluggish Pupillary reaction; Hypersensitivity to the test drug and Patient(s) not willing to give consent.
结局指标
主要结局
Medicine will likely delay or arrest the progression of senile immature cataract.
时间窗: 6 months study with three follow up ( 2nd month, 4th month, 6th month)
次要结局
- The nature of visual functional ability of clinically diagnosed patient will be improved.(6 months study with three follow up ( 2nd month, 4th month, 6th month))