Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
1 other identifier
interventional
253
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedOctober 17, 2016
December 1, 2014
1.9 years
December 7, 2014
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The time of sputum conversion between the 2 groups will be evaluated
Measured during the 8 months treatment period
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Qinbudan
EXPERIMENTALthe 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 COMPARATORthe 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
Interventions
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hebei provincial chest hospital
Shijiazhuang, Hebei, 050041, China
The first affiliated hospital of Xinxiang Medical University
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
Related Publications (1)
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.
PMID: 32381098DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guang Ji
Shanghai University of Traditional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2014
First Posted
December 10, 2014
Study Start
April 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 17, 2016
Record last verified: 2014-12