A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- improvement in nerve function and Clinical Severity Score
研究概览
简要总结
Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy
Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.
详细描述
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
- •Aged 18-65
- •Weigh more than 30Kg
排除标准
- •Unwillingness to give informed consent
- •Patients with severe active infections such as tuberculosis
- •Pregnant or breastfeeding women (see Appendix II)
- •Those with renal failure, abnormal renal function, hypertensive
- •Patients taking thalidomide currently or within the last 3 months
- •Patients not willing to return for follow-up
- •Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- •HIV positive patients
研究组 & 干预措施
ciclosporin arm
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
干预措施: Ciclosporin (Drug)
prednisolone
standard course of prednisolone given in a reducing regimen over 24 weeks
干预措施: Prednisolone (Drug)
结局指标
主要结局
improvement in nerve function and Clinical Severity Score
时间窗: at week 4, 20, 28
次要结局
- Incidence of adverse events(up to 36 weeks)
- Number of T1R recurrence episodes per patient in each treatment arm(up to 36 weeks)
- Severity of T1R recurrence for patients in each treatment arm(up to 36 weeks)
- extra prednisolone needed to control reaction(up to 36 weeks)
- 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm(36 weeks)
- Mean time to recurrence of T1R for patients in each treatment arm(up to 36 weeks)
研究者
Saba Lambert
Clinical Research Fellow
London School of Hygiene and Tropical Medicine