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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Tuberculosis
• Intervention / Treatment: Drug: Qinbudan; Drug: Qinbudan Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 101149
    • Beijing Chest Hospital,Capital Medical University
  • Chongqing, China, 400042
    • The First Affiliated Hospital of Chongqing Medical University
  • Shanghai, China, 200052
    • The 85th hospital of chinese people's liberation army
  • Shanghai, China, 200433
    • Shanghai pulmonary hospital affiliated Tongji University
  • Shenzhen, China, 518112
    • Shenzhen Donghu Hospital
  • Tianjin, China, 300350
    • Tianjin Haihe Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050041
      • Hebei provincial chest hospital
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Wuhan tuberculosis dispensary
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi provincial chest hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110044
      • Shenyang Chest Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830049
      • Uygur Autonomous Region of Xinjiang Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Qinbudan; Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice; Other Names: Qinbudan table
Placebo Comparator: 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	Drug: Qinbudan Placebo; Qinbudan Placebo was the same as therapeutic drug in package,shape,size.; Other Names: Qinbudan table Placebo

What is the study measuring?

Primary Outcome Measures

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 Measures

Outcome Measure	Measure Description	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	immunologic function(CD3、CD4、CD8)	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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Study Chair: Guang Ji, Shanghai University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 7, 2014
• First Submitted That Met QC Criteria: December 7, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Retreatment Pulmonary Tuberculosis, Qinbudan,
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: DS11036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED