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

Sponsor
Shanghai University of Traditional Chinese Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02313610
Collaborator
Ministry of Science and Technology of the People´s Republic of China (Other)
253
Enrollment
12
Locations
2
Arms
23
Duration (Months)
21.1
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
253 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The time of sputum conversion between the 2 groups will be evaluated [Measured during the 8 months treatment period]

    Secondary Outcome Measures

    1. Time to resolution of all pulmonary tuberculosis symptoms [8 months]

    2. Resolution of chest X-ray changes of patients [8 months to baseline]

    3. T cell classification in peripheral blood [8 months to baseline]

      immunologic function(CD3、CD4、CD8)

    4. Erythrocyte Sedimentation Rata [once every month during the 8 months treatment period]

    5. The cure rate will be evaluated as the primary parameter of efficacy [8-9 months]

    6. The relapse in patients of both groups will be compared [at 12 months after the completion of the therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hebei provincial chest hospital Shijiazhuang Hebei China 050041
    2 The first affiliated hospital of Xinxiang Medical University Xinxiang Henan China 453100
    3 Wuhan tuberculosis dispensary Wuhan Hubei China 430030
    4 Jiangxi provincial chest hospital Nanchang Jiangxi China 330006
    5 Shenyang chest hospital Shenyang Liaoning China 110044
    6 Uygur Autonomous Region of Xinjiang Chest Hospital Urumqi Xinjiang China 830049
    7 Beijing chest hospital,Capital medical university Beijing China 101149
    8 The first affiliated hospital of chongqing medical university Chongqing China 400042
    9 The 85th hospital of chinese people's liberation army Shanghai China 200052
    10 Shanghai pulmonary hospital affiliated Tongji University Shanghai China 200433
    11 Shenzhen Donghu hospital Shenzhen China 518112
    12 Tianjin Haihe hospital Tianjin China 300350

    Sponsors and Collaborators

    • Shanghai University of Traditional Chinese Medicine
    • Ministry of Science and Technology of the People´s Republic of China

    Investigators

    • Study Chair: Guang Ji, Shanghai University of Traditional Chinese Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai University of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    NCT02313610
    Other Study ID Numbers:
    • DS11036
    First Posted:
    Dec 10, 2014
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Dec 1, 2014
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Shanghai University of Traditional Chinese Medicine
    Retreatment Pulmonary Tuberculosis, Qinbudan,
    Additional relevant MeSH terms:
    Tuberculosis
    Tuberculosis, Pulmonary

    Study Results

    No Results Posted as of Oct 17, 2016