Double blind, parallel arm randomized controlled trial for preventing intestinal complications by concomitant prednisolone with standard anti-tuberculosis regimen in patients of abdominal tuberculosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients in each arm who develop at least one of the following within 12 months of initiating treatment: Intestinal stricture, Intestinal obstruction, Need for abdominal surgery.
研究概览
简要总结
India contributes 28% of TB cases globally. According to The Global TB Report 2020, Extrapulmonary tuberculosis (EPTB) constituted 16% of the 7.5 million reported TB cases globally and 19% in South-East Asia(1). Abdominal tuberculosis (TB) constitutes 11-13% of EPTB in India. It is a double blind, randomised, parallel arm controlled trial for preventing intestinal complications by concomitant prednisolone with standard anti-tubercular regimen in patients of abdominal tuberculosis. All randomised patients will be either placed on ATT plus steroid or ATT plus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender and Age more than 14 years Newly diagnosed and treatment naïve patients of abdominal tuberculosis Willing and able to provide written informed consent Able to comply with the study protocol and follow-up schedule.
排除标准
- 未提供
结局指标
主要结局
Proportion of patients in each arm who develop at least one of the following within 12 months of initiating treatment: Intestinal stricture, Intestinal obstruction, Need for abdominal surgery.
时间窗: 12 months
次要结局
未报告次要终点
研究者
Nitish Sharma
Jawaharlal nehru medical college and hospital, AMU