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Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis

Primary Purpose

Pulmonary Tuberculosis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Qinbudan
Qinbudan Placebo
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Tuberculosis focused on measuring Retreatment Pulmonary Tuberculosis, Qinbudan,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hebei provincial chest hospital
  • The first affiliated hospital of Xinxiang Medical University
  • Wuhan tuberculosis dispensary
  • Jiangxi provincial chest hospital
  • Shenyang chest hospital
  • Uygur Autonomous Region of Xinjiang Chest Hospital
  • Beijing chest hospital,Capital medical university
  • The first affiliated hospital of chongqing medical university
  • The 85th hospital of chinese people's liberation army
  • Shanghai pulmonary hospital affiliated Tongji University
  • Shenzhen Donghu hospital
  • Tianjin Haihe hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qinbudan

Control Qinbudan Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

The time of sputum conversion between the 2 groups will be evaluated

Secondary Outcome Measures

Time to resolution of all pulmonary tuberculosis symptoms
Resolution of chest X-ray changes of patients
T cell classification in peripheral blood
immunologic function(CD3、CD4、CD8)
Erythrocyte Sedimentation Rata
The cure rate will be evaluated as the primary parameter of efficacy
The relapse in patients of both groups will be compared

Full Information

First Posted
December 7, 2014
Last Updated
October 14, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02313610
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
Keywords
Retreatment Pulmonary Tuberculosis, Qinbudan,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qinbudan
Arm Type
Experimental
Arm 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 Title
Control Qinbudan Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Qinbudan
Other Intervention Name(s)
Qinbudan table
Intervention Description
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
Intervention Type
Drug
Intervention Name(s)
Qinbudan Placebo
Other Intervention Name(s)
Qinbudan table Placebo
Intervention Description
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Primary Outcome Measure Information:
Title
The time of sputum conversion between the 2 groups will be evaluated
Time Frame
Measured during the 8 months treatment period
Secondary Outcome Measure Information:
Title
Time to resolution of all pulmonary tuberculosis symptoms
Time Frame
8 months
Title
Resolution of chest X-ray changes of patients
Time Frame
8 months to baseline
Title
T cell classification in peripheral blood
Description
immunologic function(CD3、CD4、CD8)
Time Frame
8 months to baseline
Title
Erythrocyte Sedimentation Rata
Time Frame
once every month during the 8 months treatment period
Title
The cure rate will be evaluated as the primary parameter of efficacy
Time Frame
8-9 months
Title
The relapse in patients of both groups will be compared
Time Frame
at 12 months after the completion of the therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ji
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Hebei provincial chest hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050041
Country
China
Facility Name
The first affiliated hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
Wuhan tuberculosis dispensary
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Jiangxi provincial chest hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Shenyang chest hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110044
Country
China
Facility Name
Uygur Autonomous Region of Xinjiang Chest Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830049
Country
China
Facility Name
Beijing chest hospital,Capital medical university
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
The first affiliated hospital of chongqing medical university
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
The 85th hospital of chinese people's liberation army
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Shanghai pulmonary hospital affiliated Tongji University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shenzhen Donghu hospital
City
Shenzhen
ZIP/Postal Code
518112
Country
China
Facility Name
Tianjin Haihe hospital
City
Tianjin
ZIP/Postal Code
300350
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32381098
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.
Results Reference
derived

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Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis

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