Health Condition 1: null- Newly Diagnosed Sputum Smear Positive Pulmonary Tuberculosis Health Condition 2: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Risorine (FDC of Rifampicin
200mg + Isoniazid 300mg + Piperine 10mg): once daily for 2 months and during Continuation Phase the patients will receive 1 capsule of Risorine once daily fo
Sponsors
Cadila Pharmaceuticals Ltd Trasad Road Dholka District Ahmedabad Gujarat India
Eligibility
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the Cure Rate at 6 months in the Risorine containing anti-tubercular therapy group versus the standard anti-tubercular therapy group in patients with newly diagnosed sputum smear positive pulmonary tuberculosis 2. To evaluate the Sputum Conversion Rate at 2, 4, 6 and 8 weeks in the Risorine containing anti-tubercular therapy group versus the standard anti-tubercular therapy group in patients with newly diagnosed sputum smear positive pulmonary tuberculosisTimepoint: Comparision, by treatment group, the proportion of patients with a negative sputum smear examination at 2, 4, 6 and 8 weeks of study;1. To evaluate the Cure Rate at 6 months in the Risorine containing anti-tubercular therapy group versus the standard anti-tubercular therapy group in patients with newly diagnosed sputum smear positive pulmonary tuberculosis 2. To evaluate the Sputum Conversion Rate at 2, 4, 6 and 8 weeks in the Risorine containing anti-tubercular therapy group versus the standard anti-tubercular therapy group in patients with newly diagnosed sputum smear positive pulmonary tuberculosisTimepoint: Comparision, by treatment group, the proportion of patients with a negative sputum smear examination at 2, 4, 6 and 8 weeks of study | — |
Secondary
| Measure | Time frame |
|---|---|
| The relapse rate after completion of therapyTimepoint: Comparision of the relapse rate in the two groups at 6, 12 and 24 months after completion of therapy;To evaluate Time to Symptomatic ReliefTimepoint: At 2, 4, 6 and 8 weeks & 3, 4,5,6 month;Tolerability of test & standard treatmentTimepoint: throughout the study | — |
Countries
India
Contacts
Public ContactDr Bhaumik Mody
Cadila Pharmaceuticals Ltd
Outcome results
None listed