Role of N-Acetylcysteine as prophylactic drug for Antitubercular drug induced hepatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To calculate the difference in incidence of DILI in both treatment arms.
研究概览
简要总结
Drug Induced Liver Injury is a very common phenomenon that occurs after anti-tubercular therapy. The role of N Acetylcysteine in treatment of acetaminophen induced hepatitis is well established in medical literature. However, role of N-Acetylcysteine in ATT induced hepatitis is still under investigation with some studies suggestive of benefit and others suggesting no benefit as a prophylactic protective agent in ATT induced hepatitis.
Cilinico-radiological and/or microbiologically diagnosed tuberculosis patients will be randomly divided into two subgroups with one subgroup receiving standard treatment and the other subgroup receiving standard treatment and NAC at an oral dose of 600 mg BD for one month.
Serum LFT will be monitored at 2 weeks, 4 weeks and at 8 weeks and/or if the patient becomes symptomatic for ATT induced hepatitis in both the groups, to see the protective effects of NAC.
The role of N Acetylcysteine in preventing ATT induced hepatitis has not been well explored in the medical literature. This study aims to explore whether N Acetylcysteine can be used as a protective agent to prevent ATT induced hepatitis.
Incidences of ATT-DILI will be calculated in both the treatment arms. Subgroup analysis of incidences will be performed based on type-Pulmonary and/or Extra-Pulmonary tuberculosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed TB.
- •Started on standard dose of anti-TB drugs regimen.
- •Patient with normal hepatic transaminases and bilirubin values at baseline.
- •Patient with clinical and radiological and/or microbiological evidence of tuberculosis.
排除标准
- •Patient with age less than 18 years.
- •Previous TB infection or Multi Drug Resistant TB.
- •3.Not willing to consent for the study.
- •Pregnant females.
- •Patients with Glasgow Comma Scale score less than
- •Patients with deranged hepatic transaminases and or bilirubin at baseline.
- •Patient with peptic ulcer disease.
结局指标
主要结局
1. To calculate the difference in incidence of DILI in both treatment arms.
时间窗: 2 weeks,4 weeks and 8 weeks and if participant becomes symptomatic for ATT induced hepatitis.
次要结局
未报告次要终点