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A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosa

A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosa

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054691
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-14
Completion date
Unknown
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis pigmentosa

Interventions

Experimental group:Peiyuan Mingmu Pills
Control group:Placebo

Sponsors

Eye Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of RP; 2. In line with TCM syndrome differentiation of liver and kidney yin deficiency; 3. Aged 18 to 80 years; 4. The best corrected visual acuity of at least one eye is greater than or equal to 35 letters (equal to 20/200 on the Snellen chart) detected by the ETDRS eye chart; 5. Agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who suffer from serious systemic diseases (such as cardiovascular and cerebrovascular, liver, hematopoietic system diseases, or serious life-threatening primary diseases, mental illness or cognitive impairment, etc.) affecting the research and follow-up; 2. People with other eye diseases: optic nerve and retinal diseases, glaucoma, ocular autoimmune diseases, ocular surface diseases affecting visual function, etc.; 3. Those who are judged by the investigator to be unable to provide reliable visual field test results in static or dynamic visual field tests; 4. Suspected liver and kidney insufficiency, such as laboratory test serum creatinine exceeds the upper limit of the normal value, ALT and AST exceed the normal value range by more than 2 times; 5. Participating in or participating in clinical trials of other drugs in the past 3 months, or using similar drugs in combination with other therapies that affect the evaluation of efficacy; 6. Those who are allergic to known components of the research drug; 7. Pregnant women and lactating patients.

Design outcomes

Primary

MeasureTime frame
Visual field;

Secondary

MeasureTime frame
Visual acuity;Electroretinogram;Traditional Chinese Medicine syndrome scoring; Visual function questionnaire scoring;

Countries

China

Contacts

Public ContactChao Guojun

Eye Hospital, China Academy of Chinese Medical Sciences

13910015002@139.com+86 13910015002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026