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

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2

Conditions: Pulmonary Tuberculosis

Treatments: Drug: Qinbudan Placebo; Drug: Qinbudan

Study type: Interventional

Funder types: Other

Identifiers

NCT02313610

DS11036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 2 patient groups, including a placebo group

Qinbudan

Experimental group

Description:

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

Treatment:

Drug: Qinbudan

Control Qinbudan Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Qinbudan Placebo