CTRI/2025/04/085111尚未招募2 期
A prospective randomized placebo-controlled clinical study to evaluate the therapeutic effect of Sahadevi (Cyanthillium cinerarium (L.) H. Rob) eye drops in Timira with special reference to immature cataract.
Dr Anjana S Gokul1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in visual acuity (distance and near) assessed by Snellen’s and Jaeger’s charts
研究概览
简要总结
Cataract is the most important cause of avoidable blindness affecting 12 to 15 million persons worldwide. Till date an effective non-invasive therapy for immature cataract has not been found. The only treatment of choice is surgery. Owing to the increased incidence rate of immature cataract and possible complications and contraindications of surgery,research for the need for drugs that could effectively tackle the problem has arisen. This present clinical study aims at assessing the effectiveness of Sahadevi eye drops in comparison to placebo on immature cataract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having immature cataract.
排除标准
- •Patients suffering from inflammatory and infective disease of eyeball and its appendages.
- •Patients who are suffering from congenital cataract, mature and hyper mature cataract, traumatic cataract.
- •Any systemic disease and/or medication that interferes with the intervention of current study.
结局指标
主要结局
Improvement in visual acuity (distance and near) assessed by Snellen’s and Jaeger’s charts
时间窗: 45 days
次要结局
- 1.Reduction in symptoms such as glare, diplopia, and floaters based on patient-reported outcomes.
- 2.Change in cataract grade assessed by slit lamp examination and LOCS III classification.
- 3.Assessment of safety and tolerability through adverse drug reaction monitoring(45 days)
研究者
研究点 (1)
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