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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02313610
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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
Pulmonary Tuberculosis Drug: Qinbudan Drug: Qinbudan Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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 Name: 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 Name: Qinbudan table Placebo




Primary Outcome Measures :
  1. The time of sputum conversion between the 2 groups will be evaluated [ Time Frame: Measured during the 8 months treatment period ]

Secondary Outcome Measures :
  1. Time to resolution of all pulmonary tuberculosis symptoms [ Time Frame: 8 months ]
  2. Resolution of chest X-ray changes of patients [ Time Frame: 8 months to baseline ]
  3. T cell classification in peripheral blood [ Time Frame: 8 months to baseline ]
    immunologic function(CD3、CD4、CD8)

  4. Erythrocyte Sedimentation Rata [ Time Frame: once every month during the 8 months treatment period ]
  5. The cure rate will be evaluated as the primary parameter of efficacy [ Time Frame: 8-9 months ]
  6. The relapse in patients of both groups will be compared [ Time Frame: at 12 months after the completion of the therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313610


Locations
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China, Hebei
Hebei provincial chest hospital
Shijiazhuang, Hebei, China, 050041
China, Henan
The first affiliated hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
China, Hubei
Wuhan tuberculosis dispensary
Wuhan, Hubei, China, 430030
China, Jiangxi
Jiangxi provincial chest hospital
Nanchang, Jiangxi, China, 330006
China, Liaoning
Shenyang chest hospital
Shenyang, Liaoning, China, 110044
China, Xinjiang
Uygur Autonomous Region of Xinjiang Chest Hospital
Urumqi, Xinjiang, China, 830049
China
Beijing chest hospital,Capital medical university
Beijing, China, 101149
The first affiliated hospital of chongqing medical university
Chongqing, China, 400042
The 85th hospital of chinese people's liberation army
Shanghai, China, 200052
Shanghai pulmonary hospital affiliated Tongji University
Shanghai, China, 200433
Shenzhen Donghu hospital
Shenzhen, China, 518112
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
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Study Chair: Guang Ji Shanghai University of Traditional Chinese Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02313610    
Other Study ID Numbers: DS11036
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Retreatment Pulmonary Tuberculosis, Qinbudan,
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections