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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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