A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosa
- Conditions
- retinitis pigmentosa
- Registration Number
- ITMCTR2100005438
- Lead Sponsor
- eye hospital, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
?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.
?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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual field;
- Secondary Outcome Measures
Name Time Method Electroretinogram;Visual acuity;TCM syndrome scoring; Visual function questionnaire scoring;