Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Capsule Doxycycline: Capsule Doxycycline 100mg twice a day for 4 weeks
Control Intervention1: Placebo: Placebo 100mg twice a day for 4 weeks
Sponsors
Jawaharlal Institute of Postgraduate Medical Education & Research
Eligibility
Inclusion criteria
Inclusion criteria: Females (who have completed their family or undergone sterilization)and males- who were newly diagnosed clinically and microbiologically confirmed drug sensitive pulmonary tuberculosis patients who have been receiving anti-tubercular therapy for = 7days or about to start standard ATT with chest X-Ray demonstrating pulmonary cavity/cavities
Exclusion criteria
Exclusion criteria: Patients with extra pulmonary tuberculosis, previous history of pulmonary TB, HIV coinfections, severe preexisting lung diseases (such as fibrosis, COPD, lung cancer, bronchiectasis) and autoimmune diseases Patients with ALT/ AST >3 times upper limit of normal Patients with Creatinine > 2 times upper limit of normal Patient on antiepileptic therapy Known hypersensitivity to tetracyclines Patients who have taken tetracycline in the past 30 days preceding the dosing of study drug Patient who participated in other clinical trials in past 180 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Matrix metalloproteinase 1Timepoint: Baseline, 1month | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative lung cavity volume, wall thickness, lobe involvement, CT severity score using Low dose Chest CTTimepoint: Baseline, 6months;Matrix Metalloproteinases 3,8Timepoint: Baseline, 1month;Pulmonary function testTimepoint: 6 months;Quality of life using St George Respiratory QuestionnaireTimepoint: Baseline, 6months;Sputum microscopy/ cultureTimepoint: Baseline, end of intensive therapy, end of tuberculosis therapy | — |
Countries
India
Contacts
Public ContactDr Mirunalini R
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Outcome results
None listed