Comparative evaluation of the effect of Risorine in Patients with Newly Diagnosed Sputum Smear Positive Pulmonary Tuberculosis:

Phase 4

Completed

• Conditions: Health Condition 1: null- Newly Diagnosed Sputum Smear Positive Pulmonary TuberculosisHealth Condition 2: A150- Tuberculosis of lung

• Registration Number: CTRI/2012/06/002742
• Lead Sponsor: Cadila Pharmaceuticals Ltd Trasad Road Dholka District Ahmedabad Gujarat India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

Patients will be included if they meet the following criteria:

Males and females who are at least 18 years but not more than 65 years of age at

the time of randomization

2. Patients in weight range of 37 - 54kg

3. Confirmed diagnosis of pulmonary tuberculosis

• Sputum smear positive (One specimen positive out of two sputum samples)

• Radiological and clinical features consistent with tuberculosis

4. Willing to give informed consent

Exclusion Criteria

Patients will be excluded if they have any of the following:

1. Hypersensitivity to any of the study drugs

2. Pregnant or lactating females or women of child bearing age not following barrier

contraception or on oral contraceptives during the study period

3. HIV positive patients

4. Patients with abnormal renal function (serum creatinine more than 1.5mg/dl)

5. Patients with abnormal hepatic function [aspartate aminotransferase (AST),

alanine aminotransferase (ALT) and alkaline phosphatase (ALP) more than or equal to 3 times the upper limit of normal, or serum bilirubin more than 1.5

mg/100ml]

6. Patients with abnormal hematologic function (Hemoglobin <= 8gm/dl, WBC count

<=3000/mm3, platelet count <=100,000/mm3).

7. Seriously ill and moribund patients

8. Presence of systemic diseases such as seizure disorder, diabetes mellitus,

congestive heart failure, malignancy or chronic lung disease

9. Patients of organ transplantation and/or receiving immunosuppressive drugs

10. Patients on systemic corticosteroids for more than 7 days within the past one

month

11. Patients with history of alcohol or drug abuse

12. Patient unable, in the judgement of investigator, to comply with the treatment

regimen or the study procedures

Study & Design

• Study Type: PMS
• Study Design: Not specified