Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 410
- 主要终点
- Anti-Tuberculous Drug induced Hepatotoxicity
研究概览
简要总结
OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi.
SAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea) ,Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke will be excluded
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age
- •either gender.
排除标准
- •History of malignancy.
- •Patients with history of seropositive, seronegative, connective tissue disorder or vasculitis, congestive cardiac failure.
- •Patients with history of alcohol use.
- •Discontinuation of drug due to other adverse effects except hepatotoxicity.
- •Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation.
- •Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea).
- •Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke.
研究组 & 干预措施
group C
patients taking antituberculous drugs only
干预措施: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z) (Drug)
group A
patients taking antituberculous drugs with silymarin
干预措施: Silymarin 420 mg (Drug)
group B
patients taking antituberculous drugs with N-acetylcysteine
干预措施: N Acetyl Cysteine (Drug)
结局指标
主要结局
Anti-Tuberculous Drug induced Hepatotoxicity
时间窗: 14 days
Outcome will be assessed in patients developing Anti-tuberculous Drug-Induced Hepatotoxicity. Patients diagnosed with TB and started on a regimen based on isoniazid, rifampicin, pyrazinamide, and ethambutol will be labeled as having Anti-tuberculous Drug-Induced Hepatotoxicity using liver function tests. It will be labeled if any one of the following criteria is met: * Rise in alanine aminotransferase (ALT) more than or equal to a fivefold increase from the upper limit of normal (\>37 IU/L) * Rise in alkaline phosphatase (ALP) more than or equal to twofold increase from the upper limit of normal (\>147 IU/L). * An increase in alanine aminotransferase (ALT) to three or more times the upper normal limit (greater than 37 IU/L), accompanied by a simultaneous rise in bilirubin levels to more than twice the upper normal limit (exceeding 1.5 mg/dL), will be considered significant.
次要结局
未报告次要终点
研究者
Ariba SULTAN
Principal investigator
Liaquat National Hospital & Medical College