Efficacy and Safety of Qinbudan as an Adjunct Therapy in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 12
- 主要终点
- The time of sputum conversion between the 2 groups will be evaluated
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Qinbudan (Drug)
Control 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
干预措施: Qinbudan Placebo (Drug)
结局指标
主要结局
The time of sputum conversion between the 2 groups will be evaluated
时间窗: Measured during the 8 months treatment period
次要结局
- 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)
- 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)