CTRI/2021/11/037978招募中未知
Evaluation of Hepatoprotective activity of PTK as an add on therapy in the patients of Tuberculosis on ATT - A Double blind Randomized control clinical study
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Diagnosed cases of tuberculosis (pulmonary and extra pulmonary TB)
- •2. Eligible for 1st line ATT regimen.
- •3. Patients of any gender aged between18- 60 years eligible for 6/9 months ATT regimen.
- •4. Newly diagnosed Patients of TB with their hepatic enzymes ranging within normal limits (defined as AST 5-40 and ALT 5-40 U/L).
- •5. Willing to give consent and able to participate for 6 months in the study.
排除标准
- •1. Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •2. Symptomatic patients with clinical evidence of congestive cardiac failure.
- •3. Patients with concurrent Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl in adult males and >1.2 mg/dl in adult females), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 4. Known cases of Hepatitis and Diabetes Mellitus. 5. Known cases of HIV and AIDS.
- •6. Known cases of malignancy
- •7. Patients of Hyperthyroidism
- •8. Patient taking participation in any other clinical trial.
- •9. Women who are planning for conception / planned pregnancy within the next year/ pregnant or lactating.
- •10. Subjects with chronic liver disease or hepatocellular carcinoma
- •11. serological evidence of acute viral hepatitis (Hepatitis A, BC,D etc), , human immunodeficiency virus (HIV) infection,
- •12. Long-term alcoholism (defined as consumption of >48 g of alcohol per day for at least 1 year or drug abuse (positive urine drug screen) or history thereof within the past 2 years that is, in the opinion of the Investigator, sufficient to compromise the safety and/or cooperation of the Subject.
- •13. concomitant use of potentially hepatotoxic drugs (eg, methotrexate, phenytoin, valproate, and fluconazole)
- •14. Prior history of ATT (Anti Tubercular Treatment) with documented hepatotoxicity.
- •15. Any other condition which the P.I. thinks may jeopardize the study
研究者
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