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

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

Sponsors

Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Collaborator: Ministry of Science and Technology of the People´s Republic of China

Source Shanghai University of Traditional Chinese Medicine
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.

Overall Status Completed
Start Date April 2011
Completion Date March 2013
Primary Completion Date March 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The time of sputum conversion between the 2 groups will be evaluated Measured during the 8 months treatment period
Secondary Outcome
Measure 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 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
Enrollment 253
Condition
Intervention

Intervention Type: Drug

Intervention Name: Qinbudan

Description: Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice

Arm Group Label: Qinbudan

Other Name: Qinbudan table

Intervention Type: Drug

Intervention Name: Qinbudan Placebo

Description: Qinbudan Placebo was the same as therapeutic drug in package,shape,size.

Arm Group Label: Control Qinbudan Placebo

Other Name: Qinbudan table Placebo

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Guang Ji Study Chair Shanghai University of Traditional Chinese Medicine
Location
Facility:
Hebei provincial chest hospital | Shijiazhuang, Hebei, 050041, China
The first affiliated hospital of Xinxiang Medical University | Xinxiang, Henan, 453100, China
Wuhan tuberculosis dispensary | Wuhan, Hubei, 430030, China
Jiangxi provincial chest hospital | Nanchang, Jiangxi, 330006, China
Shenyang chest hospital | Shenyang, Liaoning, 110044, China
Uygur Autonomous Region of Xinjiang Chest Hospital | Urumqi, Xinjiang, 830049, China
Beijing chest hospital,Capital medical university | Beijing, 101149, China
The first affiliated hospital of chongqing medical university | Chongqing, 400042, China
The 85th hospital of chinese people's liberation army | Shanghai, 200052, China
Shanghai pulmonary hospital affiliated Tongji University | Shanghai, 200433, China
Shenzhen Donghu hospital | Shenzhen, 518112, China
Tianjin Haihe hospital | Tianjin, 300350, China
Location Countries

China

Verification Date

December 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Qinbudan

Type: Experimental

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

Label: Control Qinbudan Placebo

Type: Placebo Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov