ITMCTR2100005438
Not yet recruiting
Phase 1
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 sitesTBD
Conditionsretinitis pigmentosa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- retinitis pigmentosa
- Sponsor
- eye hospital, China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?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.
Exclusion Criteria
- •?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.
Outcomes
Primary Outcomes
Not specified
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