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se of doxycycline in tuberculosis (TB) patients

Phase 3
Conditions
Health Condition 1: A150- Tuberculosis of lung
Registration Number
CTRI/2024/01/061473
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Matrix metalloproteinase 1Timepoint: Baseline, 1month
Secondary Outcome Measures
NameTimeMethod
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
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