Effect of Glucosamine on Intraocular Pressure
试验速览
- 阶段
- 3 期
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Intraocular pressure changes
研究概览
简要总结
In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
- •No history of using drugs tested in the study.
排除标准
- •History of any kind of corneal surgery.
- •History of intraocular surgery.
- •History of diabetes mellitus.
- •Heavy smokers.
- •Unwillingness to participate in the study.
研究组 & 干预措施
Administration of the Placebo
Placebo three times a day.
干预措施: Placebo three times a day (Drug)
Administration of the glucosamine sulfate
glucosamine sulfate 1500 mg three times a day
干预措施: glucosamine sulfate 1500 mg three times a day (Drug)
结局指标
主要结局
Intraocular pressure changes
时间窗: until 6 months
: Goldmann applanation tonometry
次要结局
- corneal biomechanical changes(until 6 months)
研究者
Zahra Rabbani Khah
clinical professor ,ophthalmic research center
Shahid Beheshti University of Medical Sciences