Status:
COMPLETED
Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 conditio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT02313610
Start Date
April 1 2011
End Date
March 1 2013
Last Update
October 17 2016
Active Locations (12)
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1
Hebei provincial chest hospital
Shijiazhuang, Hebei, China, 050041
2
The first affiliated hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
3
Wuhan tuberculosis dispensary
Wuhan, Hubei, China, 430030
4
Jiangxi provincial chest hospital
Nanchang, Jiangxi, China, 330006