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
Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
Sponsors
Source
Shanghai University of Traditional Chinese Medicine
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2011-04-01
Completion Date
2013-03-01
Primary Completion Date
2013-03-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
The time of sputum conversion between the 2 groups will be evaluated |
Measured during the 8 months treatment period |
Secondary Outcome
Measure |
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 |
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 |
Enrollment
253
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
Arm Group Label
Qinbudan
Other Name
Qinbudan table
Intervention Type
Drug
Intervention Name
Description
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Arm Group Label
Control Qinbudan Placebo
Other Name
Qinbudan table Placebo
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
Gender
All
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Guang Ji |
Study Chair |
Shanghai University of Traditional Chinese Medicine |
Location
Facility |
|
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 Urumqi 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 |
Location Countries
Country
China
Verification Date
2014-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Qinbudan
Arm Group Type
Experimental
Description
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
Arm Group Label
Control Qinbudan Placebo
Arm Group Type
Placebo Comparator
Description
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
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
December 7, 2014
Study First Submitted Qc
December 7, 2014
Study First Posted
December 10, 2014
Last Update Submitted
October 14, 2016
Last Update Submitted Qc
October 14, 2016
Last Update Posted
October 17, 2016
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.