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A prospective, randomized, double-blind, placebo parallel controlled, dual center clinical trial of Peiyuan Mingmu Pill in the treatment of retinitis pigmentosa

A prospective, randomized, double-blind, placebo parallel controlled, dual center clinical trial of Peiyuan Mingmu Pill in the treatment of retinitis pigmentosa

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086280
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Retinitis pigmentosa

Interventions

Test 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 retinitis pigmentosa. 2. Up to the syndrome of TCM:liver and kidney depletion. 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, and the visual field radius of at least one eye is greater than 5°. 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 results of visual field in static or dynamic visual field tests. 4. Suspected liver and kidney insufficiency, such as laboratory test of 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 clinical trials of other drugs in the past 3 months, or taking 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 or lactating patients.

Design outcomes

Primary

MeasureTime frame
Visual field;

Secondary

MeasureTime frame
Best corrected visual acuity;Electroretinogram;TCM syndrom score ;Visual function questionnaire score;

Countries

China

Contacts

Public ContactYamin Li

Eye Hospital, China Academy of Chinese Medical Sciences

1542664515@qq.com+86 150 3908 2070

Outcome results

None listed

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