Last reviewed · How we verify
Efficacy and Safety of Immunomodulator (Mycobacterium w.) as an Adjunct Therapy in Category I Pulmonary Tuberculosis and Along With Assessment of Immunological Parameters
The purpose of the study is to evaluate the efficacy and safety of Mycobacterium w in new lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as vaccine and adjunct drug against leprosy. This agent has also been found to be useful in the treatment of lung tuberculosis in limited number of patients. We are conducting this study in category-I patients( As per World Health Organization,Geneva classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see any change in the immunological parameters.
Details
| Lead sponsor | Ministry of Science and Technology, India |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 300 |
| Start date | 2007-03 |
| Completion | 2012-03 |
Conditions
- Tuberculosis
Interventions
- Intradermal injection of Mycobacterium w
Primary outcomes
- The time of sputum conversion as well as the early sputum conversion between the two groups will be evaluated. — from the baseline(visit 2)
- The cure rate will be evaluated as the primary parameter of efficacy. — 6-7 month
- The relapse in patients of category-I pulmonary TB will be compared in both the groups. — at an interval of 6,12,18 and 24 months after the completion of the therapy
- Recording of any clinical adverse reactions for assessment of safety. — at anytime during the study
Countries
India