Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
- Registration Number
- NCT02313610
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
- Patients who are initially sputum smear positive (at least two smears as "1+" or at least have a smear as "2+" and above) or culture-positive for pulmonary tuberculosis who have been treated previously
- Aged 18 -65 years of age
- Patients who are willing to give written informed consent
- Participation in another clinical trial 1 month prior to study entry
- Female patients in lactation period, pregnancy or planning to get pregnant during the trial
- Patients who are allergic to the therapeutic medicine
- Patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases
- Patients co-infected with HIV, hepatitis B or hepatitis C
- Patients with mental illness, acrasia
- Abnormal liver function or combined with other underlying liver disease (fatty liver, alcoholic liver)
- Patients with diabetes, Plasma glucose poorly controlled undertaking
- Patients with auditory dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qinbudan Qinbudan 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 Qinbudan Placebo 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
- Primary Outcome Measures
Name Time Method The time of sputum conversion between the 2 groups will be evaluated Measured during the 8 months treatment period
- Secondary Outcome Measures
Name Time Method 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 8 months to baseline immunologic function(CD3、CD4、CD8)
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
Trial Locations
- Locations (12)
Tianjin Haihe hospital
🇨🇳Tianjin, China
The first affiliated hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Jiangxi provincial chest hospital
🇨🇳Nanchang, Jiangxi, China
The first affiliated hospital of chongqing medical university
🇨🇳Chongqing, China
Wuhan tuberculosis dispensary
🇨🇳Wuhan, Hubei, China
Uygur Autonomous Region of Xinjiang Chest Hospital
🇨🇳Urumqi, Xinjiang, China
The 85th hospital of chinese people's liberation army
🇨🇳Shanghai, China
Shanghai pulmonary hospital affiliated Tongji University
🇨🇳Shanghai, China
Shenzhen Donghu hospital
🇨🇳Shenzhen, China
Hebei provincial chest hospital
🇨🇳Shijiazhuang, Hebei, China
Shenyang chest hospital
🇨🇳Shenyang, Liaoning, China
Beijing chest hospital,Capital medical university
🇨🇳Beijing, China