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临床试验/NCT04351100
NCT04351100已完成不适用

Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Corneal staining score change from baseline at 2 months

研究概览

简要总结

Dry eyes is multi-factorial disease which inflammation play etiological role. Diacerein is drug which has anti-inflammatory effect by antagonist Interleukin-1, decrease Interleukin-1 receptor, increase Interleukin-1 Receptor antagonist. This observational study enrolled participants who going to take diacerein for osteoarthritis, measure corneal staining score, Ocular surface disease index score, Tear Osmolarity, Tear break up time, Schirmer 1 test, Interleukin-1 Receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear at the time of enrollment and after 2 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoarthritis with
  • Ocular surface index score ≥ 13 with
  • Corneal staining score ≥ 3

排除标准

  • Allergic to diacerein
  • Use Cyclosporin within 30 days
  • Eyelid problem
  • Change artificial tear while in the study
  • Pregnancy or breast feeding

研究组 & 干预措施

Diacerein group

Osteoarthritis and dry eye patients treated with Diacerein

干预措施: Diacerein (Drug)

结局指标

主要结局

Corneal staining score change from baseline at 2 months

时间窗: At the time of enrollment and 2 months

Stain Cornea with Fluorescine, count and score staining at the cornea according to National eye institute : score 0-15 (0=no staining)

次要结局

  • Ocular surface disease index score(At the time of enrollment and 2 months)
  • Tear Osmolarity(At the time of enrollment and 2 months)
  • Interleukin-1 receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear(At the time of enrollment and 2 months)
  • Tear break up time(At the time of enrollment and 2 months)
  • Schirmer 1 test(At the time of enrollment and 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ngamjit Kasetsuwan

Associate professor

Chulalongkorn University

研究点 (1)

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