ITMCTR2100005438尚未招募1 期
A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosa
eye hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •?Diagnosis of RP;
- •?Comply with TCM syndrome differentiation of liver and kidney yin deficiency syndrome;
- •?Age between 18-80 years old;
- •?Visual acuity of greater than or equal to 35 letters in at least one eye as measured by the EVA-ETDRS (equivalent to 20/200 on a Snellen chart);
- •?Understand and sign the informed consent document for the study.
排除标准
- •?Medical problems that make consistent follow-up over the treatment period unlikely (e.g. cardio-cerebrovascular, liver, hematopoietic system diseases, or severely life-threatening primary diseases, mental illness or cognitive impairment, etc.);
- •?Other eye diseases: optic nerve and retinal diseases, glaucoma, ocular autoimmune diseases, ocular surface diseases that affect visual function, etc;
- •?Subject unable to provide reliable perimetry measurements in both eyes for both static and kinetic visual field, as determined by the Reading Center;
- •?Suspected liver and kidney dysfunction determined by having alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevated more than 2 times beyond the normal, and blood creatinine above the upper limit of normal;
- •?RP patients involved in other clinical trials within the last 3 months, or had taken one of the similar drugs or other therapies that affect the evaluation of efficacy;
- •?Sensitive to or have ever had an allergic reaction to known ingredients of research drugs;
- •?Pregnant women and lactating mothers who are breast feeding their babies.
研究者
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