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

NCT ID: NCT02313610

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-03-31

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.

Conditions

Pulmonary Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Qinbudan

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

Group Type: EXPERIMENTAL

Qinbudan

Intervention Type: DRUG

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

Control Qinbudan Placebo

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

Group Type: PLACEBO_COMPARATOR

Qinbudan Placebo

Intervention Type: DRUG

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

Interventions

Qinbudan

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

Intervention Type: DRUG

Qinbudan Placebo

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

Intervention Type: DRUG

Other Intervention Names

Qinbudan table; 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guang Ji

Role: STUDY_CHAIR

Shanghai University of Traditional Chinese Medicine

Locations

Hebei provincial chest hospital

Shijiazhuang, Hebei, China

The first affiliated hospital of Xinxiang Medical University

Xinxiang, Henan, China

Wuhan tuberculosis dispensary

Wuhan, Hubei, China

Jiangxi provincial chest hospital

Nanchang, Jiangxi, China

Shenyang chest hospital

Shenyang, Liaoning, China

Uygur Autonomous Region of Xinjiang Chest Hospital

Ürümqi, Xinjiang, China

Beijing chest hospital,Capital medical university

Beijing, , China

The first affiliated hospital of chongqing medical university

Chongqing, , China

The 85th hospital of chinese people's liberation army

Shanghai, , China

Shanghai pulmonary hospital affiliated Tongji University

Shanghai, , China

Shenzhen Donghu hospital

Shenzhen, , China

Tianjin Haihe hospital

Tianjin, , China

Countries

China

References

Zhang SY, Fu JY, Guo XY, Wu DZ, Zhang T, Li C, Qiu L, Shao CR, Xiao HP, Chu NH, Deng QY, Zhang X, Yan XF, Wang ZL, Zhang ZJ, Jiang X, Zheng YJ, Zheng PY, Zhang HY, Lu ZH. Improvement cues of lesion absorption using the adjuvant therapy of traditional Chinese medicine Qinbudan tablet for retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen. Infect Dis Poverty. 2020 May 7;9(1):50. doi: 10.1186/s40249-020-00660-z.

Reference Type: DERIVED

PMID: 32381098 (View on PubMed)

Other Identifiers

DS11036

Identifier Type: -

Identifier Source: org_study_id