Clinical trial NCT02313610: Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Tuberculosis
Keywords: Retreatment Pulmonary Tuberculosis, Qinbudan,
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-12-10
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The time of sputum conversion between the 2 groups will be evaluated
timeFrame: Measured during the 8 months treatment period
Secondary outcomes:
measure: Time to resolution of all pulmonary tuberculosis symptoms
timeFrame: 8 months
measure: Resolution of chest X-ray changes of patients
timeFrame: 8 months to baseline
measure: T cell classification in peripheral blood
timeFrame: 8 months to baseline
measure: Erythrocyte Sedimentation Rata
timeFrame: once every month during the 8 months treatment period
measure: The cure rate will be evaluated as the primary parameter of efficacy
timeFrame: 8-9 months
measure: The relapse in patients of both groups will be compared
timeFrame: at 12 months after the completion of the therapy
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei provincial chest hospital
state: Hebei
city: Xinxiang
country: China
facility: The first affiliated hospital of Xinxiang Medical University
state: Henan
city: Wuhan
country: China
facility: Wuhan tuberculosis dispensary
state: Hubei
city: Nanchang
country: China
facility: Jiangxi provincial chest hospital
state: Jiangxi
city: Shenyang
country: China
facility: Shenyang chest hospital
state: Liaoning
city: Urumqi
country: China
facility: Uygur Autonomous Region of Xinjiang Chest Hospital
state: Xinjiang
city: Beijing
country: China
facility: Beijing chest hospital,Capital medical university
city: Chongqing
country: China
facility: The first affiliated hospital of chongqing medical university
city: Shanghai
country: China
facility: The 85th hospital of chinese people's liberation army
city: Shanghai
country: China
facility: Shanghai pulmonary hospital affiliated Tongji University
city: Shenzhen
country: China
facility: Shenzhen Donghu hospital
city: Tianjin
country: China
facility: Tianjin Haihe hospital
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Guang Ji
role: STUDY_CHAIR
References:
citation: 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.