Skip to content

Multi-center clinical study of Yangxue Runmu prescription in the treatment of moderate to severe dry eye

Multi-center clinical study of Yangxue Runmu prescription in the treatment of moderate to severe dry eye

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057440
Enrollment
Unknown
Registered
2022-03-12
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

dry eye

Interventions

control group:Oral Chinese medicine placebo+0.1% sodium hyaluronate eye drops
therapy group:Oral Chinese medicine of Yangxue Runmu prescription+0.1% sodium hyaluronate eye drops

Sponsors

Eye Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18-80 years old, meeting the dry eye diagnostic criteria: 1) Dry eyes can be diagnosed if one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, vision fluctuation and BUT = 5s or Schirmer ? = 5 mm/5 min without surface anesthesia; 2) Dry eyes can be diagnosed when there are one of subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation, and when 5s < BUT = 10s or 5 mm/5 min < Schirmer I test result without topical anesthesia = 10mm/5 min, and there is also positive staining of keratoconjunctiva fluorescein. 2. Comply with the grading standard of dry eye severity: 1) Moderate: under slit lamp microscope, the scope of corneal damage should not exceed 2 quadrants and (or) the number of corneal fluorescein staining points should be = 5 and<30, and the BUT should be 2 s or more; 2) Severity: Slit lamp microscope examination showed that the corneal damage range was 2 quadrants or more and (or) corneal fluorescent staining points = 30, BUT<2s. The corneal fluorescein staining spots fused into thick spots, sheets or filaments.

Exclusion criteria

Exclusion criteria: 1. People with eye trauma, conjunctival, corneal diseases, glaucoma or eye infection; 2. Complicated with other serious diseases, such as tumor, immune disease, etc; 3. Eye surgery within 3 months; 4. Pregnant or lactating women; 5. Wearing corneal contact lenses; 6. People who are allergic to the drugs used in this study; 7. Being involved in other clinical drug trials; 8. Complicated with heart, liver, kidney, hematopoietic system and other serious diseases.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index, OSDI;Ocular Surface Inflammation Grading;inflammatory factor MMP9;inflammatory factor TNFa;inflammatory factor IL-6;Changes in conjunctival epithelial cells;Changes in conjunctival goblet cells;

Countries

China

Contacts

Public ContactNingling Wu

Eye Hospital of China Academy of Chinese Medical Sciences

wuningling@126.com+86 18611750667

Outcome results

None listed

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