The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.
Retreatment of tuberculosis involves the management of entities as diverse as relapse, failure, treatment after default, and poor patient adherence to the previous treatment. The emergence of conditions for selection of resistance (failure and partial abandonment) is a matter of great concern. The current chemotherapy is the primary interventions, but the long-term drug combination therapy often leads to adverse reactions. The purpose of this study that is to exploring the role of Chinese medicine Qinbudan on Patients who are initially sputum smear positive or culture-positive who have been treated previously for pulmonary tuberculosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
253
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Hebei provincial chest hospital
Shijiazhuang, Hebei, China
The first affiliated hospital of Xinxiang Medical University
Xinxiang, Henan, China
Wuhan tuberculosis dispensary
Wuhan, Hubei, China
The time of sputum conversion between the 2 groups will be evaluated
Time frame: Measured during the 8 months treatment period
Time to resolution of all pulmonary tuberculosis symptoms
Time frame: 8 months
Resolution of chest X-ray changes of patients
Time frame: 8 months to baseline
T cell classification in peripheral blood
immunologic function(CD3、CD4、CD8)
Time frame: 8 months to baseline
Erythrocyte Sedimentation Rata
Time frame: once every month during the 8 months treatment period
The cure rate will be evaluated as the primary parameter of efficacy
Time frame: 8-9 months
The relapse in patients of both groups will be compared
Time frame: at 12 months after the completion of the therapy
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Jiangxi provincial chest hospital
Nanchang, Jiangxi, China
Shenyang chest hospital
Shenyang, Liaoning, China
Uygur Autonomous Region of Xinjiang Chest Hospital
Ürümqi, Xinjiang, China
Beijing chest hospital,Capital medical university
Beijing, China
The first affiliated hospital of chongqing medical university
Chongqing, China
The 85th hospital of chinese people's liberation army
Shanghai, China
Shanghai pulmonary hospital affiliated Tongji University
Shanghai, China
...and 2 more locations