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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qinbudan | Experimental | the patient will receive 2HRZES/6HRE follow guidelines of the implementation of China tuberculosis control program (2HRZES/6HRE means: Intensive phase: isoniazid(H), rifampicin(R), pyrazinamide(Z), ethambutol(E), streptomycin(S), once, for two months(2);Consolidation: isoniazid(H), rifampicin(R), ethambutol(E), once, for six months(6).) Intervention: Qinbudan table, table, 4, thrice a day, 8 months |
|
| Control Qinbudan Placebo | Placebo Comparator | the patient will receive 2HRZES/6HRE follow guidelines of the implementation of China tuberculosis control program(2HRZES/6HRE means: Intensive phase: isoniazid(H), rifampicin(R), pyrazinamide(Z), ethambutol(E), streptomycin(S), once, for two months(2);Consolidation: isoniazid(H), rifampicin(R), ethambutol(E), once, for six months(6).) Intervention: Qinbudan Placebo, table, 4, thrice a day, 8 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qinbudan | Drug | Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time of sputum conversion between the 2 groups will be evaluated | Measured during the 8 months treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of all pulmonary tuberculosis symptoms | 8 months | |
| Resolution of chest X-ray changes of patients | 8 months to baseline | |
| T cell classification in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guang Ji | Shanghai University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei provincial chest hospital | Shijiazhuang | Hebei | 050041 | China | ||
| The first affiliated hospital of Xinxiang Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32381098 | Derived | Zhang SY, Fu JY, Guo XY, Wu DZ, Zhang T, Li C, Qiu L, Shao CR, Xiao HP, Chu NH, Deng QY, Zhang X, Yan XF, Wang ZL, Zhang ZJ, Jiang X, Zheng YJ, Zheng PY, Zhang HY, Lu ZH. Improvement cues of lesion absorption using the adjuvant therapy of traditional Chinese medicine Qinbudan tablet for retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen. Infect Dis Poverty. 2020 May 7;9(1):50. doi: 10.1186/s40249-020-00660-z. |
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| Qinbudan Placebo | Drug | Qinbudan Placebo was the same as therapeutic drug in package,shape,size. |
|
|
immunologic function(CD3、CD4、CD8) |
| 8 months to baseline |
| Erythrocyte Sedimentation Rata | once every month during the 8 months treatment period |
| The cure rate will be evaluated as the primary parameter of efficacy | 8-9 months |
| The relapse in patients of both groups will be compared | at 12 months after the completion of the therapy |
| Xinxiang |
| Henan |
| 453100 |
| China |
| Wuhan tuberculosis dispensary | Wuhan | Hubei | 430030 | China |
| Jiangxi provincial chest hospital | Nanchang | Jiangxi | 330006 | China |
| Shenyang chest hospital | Shenyang | Liaoning | 110044 | China |
| Uygur Autonomous Region of Xinjiang Chest Hospital | Ürümqi | Xinjiang | 830049 | China |
| Beijing chest hospital,Capital medical university | Beijing | 101149 | China |
| The first affiliated hospital of chongqing medical university | Chongqing | 400042 | China |
| The 85th hospital of chinese people's liberation army | Shanghai | 200052 | China |
| Shanghai pulmonary hospital affiliated Tongji University | Shanghai | 200433 | China |
| Shenzhen Donghu hospital | Shenzhen | 518112 | China |
| Tianjin Haihe hospital | Tianjin | 300350 | China |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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