Study of Hepatoprotective activity of PTK as an add on therapy in the patients of Tuberculosis on ATT - A Double blind Randomized control clinical study

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the hepato-protective potential of PTK in the patients of TB on ATT regimen, assessed through estimation of plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline Phosphatases and bilirubin )Timepoint: Baseline 30th Day 60th day 120th Day 180th Day

Secondary Outcome Measures

Name	Time	Method
To compare the incidence of ATT induced hepatitis in both groups <br/ ><br>Proportion of patients completing the ATT regimen without need for drug substitution drug withdrawal or dosage regimen adjustment <br/ ><br>Timepoint: Baseline 30th Day 60th Day 120th Day 180th Day