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A randomized controlled study of total glucosides of paeony in the treatment of moderate and severe dry eye

A randomized controlled study of total glucosides of paeony in the treatment of moderate and severe dry eye

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062993
Enrollment
Unknown
Registered
2022-08-27
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

dry eye

Interventions

Experimental group:Total Glucosides of Paeony Capsules
Control group:None

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age =18 to =75 years old (up to the screening date); (2) Diagnostic criteria for dry eye in accordance with the Expert Consensus of Dry Eye in China: Examination and Diagnosis (2020); And moderate to severe dry eyes. (3) Those who did not participate in any drug test within 3 months before inclusion; (4) Understand the whole process of the test, voluntarily participate in and sign the informed consent;

Exclusion criteria

Exclusion criteria: (1) pregnant women, women planning pregnancy or breast-feeding; (2) Patients with a history of chronic diarrhea or peptic ulcer within the past 1 year; (3) patients with uncontrolled severe hypertension and metabolic diseases (such as diabetes); (4) patients suffering from malignant tumors; (5) persons suffering from acute and or chronic infectious diseases; (6) persons with mental disorders, history of alcohol abuse, drug or other substance abuse; (7) Patients with a history of allergy to any component of the drugs or tests intended for use in the study (e.g., total glucosides of paeonia lactiflora capsules, fluorescein, lisamine green); (8) systemic use of glucocorticoids during the study period; (9) have other conditions that researchers consider not to be included in the clinical trial, such as lacrimal duct obstruction;

Design outcomes

Primary

MeasureTime frame
Ocular surface disease index score;Corneal staining score and conjunctiva staining score;

Secondary

MeasureTime frame
Time of tear film rupture stained by fluorescein;Schirmer ? test;Height of the river of tears;

Countries

China

Contacts

Public ContactGuigang Li

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

guigli@163.com13986046874

Outcome results

None listed

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