Pulmonary Tuberculosis
Conditions
Keywords
Retreatment Pulmonary Tuberculosis, Qinbudan,
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.
Interventions
DRUGQinbudan
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
DRUGQinbudan Placebo
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time of sputum conversion between the 2 groups will be evaluated | Measured during the 8 months treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of chest X-ray changes of patients | 8 months to baseline | — |
| T cell classification in peripheral blood | 8 months to baseline | immunologic function(CD3、CD4、CD8) |
| Time to resolution of all pulmonary tuberculosis symptoms | 8 months | — |
| 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 | — |
| Erythrocyte Sedimentation Rata | once every month during the 8 months treatment period | — |
Countries
China
Outcome results
None listed