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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Tuberculosis

Intervention / Treatment
-----------------
* Drug: Qinbudan
* Drug: Qinbudan Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qinbudan<br>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<br>* Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice<br>* Other names: Qinbudan table;|
| Placebo Comparator: Control Qinbudan Placebo<br>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<br>* Qinbudan Placebo was the same as therapeutic drug in package,shape,size.<br>* Other names: Qinbudan table Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retreatment Pulmonary Tuberculosis, Qinbudan,