CTRI/2024/06/069125尚未招募4 期
TO STUDY AND COMPARE THE EFFECTIVENESS OF ORAL TOFACITINIB PLUS ORAL PUVASOL VS ORAL CORTICOSTEROIDS PLUS ORAL PUVASOL IN VITILIGO - A RANDOMIZED CONTROL TRIAL.
SUPRIYA BEHERA1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Repigmentation in test (18 patients ) and control group (18 patients ) comparing with VASI score at 12 and 24 weeks.
研究概览
简要总结
This is a open label randomized controlled trial with sample size of 36, 18 in test group and 18 in control group.
Sample size is calculated using superiority trial method.
The subjects will be ramdomized using compurter based radmond application and test group will be given oral tofacitinib plus oral puvasol and control group will be given oral corticosteroids plus oral puvasol.
Repigmentation in the form of VASI score will be compared at 12 weeks and 24 weeks.
The additional side effects in the form of secondary outcome will be seen as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •Body surface area less than 80%
- •Progressive disease( peak of incidence within 6 months ).
排除标准
- •Universal vitiligo
- •Pregnant and lactating women
- •Patients undergoing immunosuppressive therapy
- •Patients of leukoderma due to other causes
- •Patients having photosensitivity
- •Patients having malignancy or undergone radiotherapy.
结局指标
主要结局
Repigmentation in test (18 patients ) and control group (18 patients ) comparing with VASI score at 12 and 24 weeks.
时间窗: 12 and 24 weeks
次要结局
- Study the side effects of drugs in both the test & control group(12 & 24 weeks)
研究者
SUPRIYA BEHERA
SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK
研究点 (1)
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