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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
ITMCTR
Registry ID
ITMCTR2100005438
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-14
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

retinitis pigmentosa

Interventions

Study group:Peiyuan Mingmu Pills

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: ?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

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.

Design outcomes

Primary

MeasureTime frame
Visual field;

Secondary

MeasureTime frame
Electroretinogram;Visual acuity;TCM syndrome scoring; Visual function questionnaire scoring;

Countries

China

Contacts

Public ContactGuojun Chao
13910015002@139.com13910015002

Outcome results

None listed

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