Multicenter, Randomized and Double-blind Controlled Clinical Trial of Integrative Medicine Therapy for Treatment of multi-drug-resistant pulmonary tuberculosis

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2012
INTERVENTION: treatment group:Conventional treatment+ traditional Chinese medicine ;control group:Conventional treatment+ placebo ; CONDITION: Multi‐drug resistant pulmonary tuberculosis (MDR‐PTB) PRIMARY OUTCOME: sputum negative conversion rate;Changes in pulmonary lesions;Time to sputum culture conversion; SECONDARY OUTCOME: Change of the TCM syndrome scores;Treatment failure rate;Treatment completion rate;immunologic function(CD3, CD4, CD8);Change of body mass index;Quality of life score (SF36 score);Erythrocyte Sedimentation Rate (ESR); INCLUSION CRITERIA: 1. Sputum cultures positive for Mycobacterium tuberculosis that is resistant at least to isoniazid (INH) and rifampicin (RMP); 2. Syndrome differentiation belongs to syndrome of yin deficiency and lung heat, syndrome of qi and yin deficiency; 3. Aged 18 to 65 years; 4. course of tuberculosis>=2 months, <=8 years; 5. patients have fully understand the study, voluntary take the test and informed agreement signed.
Epistemonikos ID: e19a9a2fce614dc5034fa286653e0a417e3190c7
First added on: Aug 22, 2024