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

Pulmonary Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313610
• Other study ID #: DS11036
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2014
• Last updated: October 14, 2016
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Qinbudan
Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
• Qinbudan Placebo
Qinbudan Placebo was the same as therapeutic drug in package,shape,size.

Locations

Country	Name	City	State
China	Beijing chest hospital,Capital medical university	Beijing
China	The first affiliated hospital of chongqing medical university	Chongqing
China	Jiangxi provincial chest hospital	Nanchang	Jiangxi
China	Shanghai pulmonary hospital affiliated Tongji University	Shanghai
China	The 85th hospital of chinese people's liberation army	Shanghai
China	Shenyang chest hospital	Shenyang	Liaoning
China	Shenzhen Donghu hospital	Shenzhen
China	Hebei provincial chest hospital	Shijiazhuang	Hebei
China	Tianjin Haihe hospital	Tianjin
China	Uygur Autonomous Region of Xinjiang Chest Hospital	Urumqi	Xinjiang
China	Wuhan tuberculosis dispensary	Wuhan	Hubei
China	The first affiliated hospital of Xinxiang Medical University	Xinxiang	Henan

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of sputum conversion between the 2 groups will be evaluated		Measured during the 8 months treatment period	Yes
Secondary	Time to resolution of all pulmonary tuberculosis symptoms		8 months	Yes
Secondary	Resolution of chest X-ray changes of patients		8 months to baseline	Yes
Secondary	T cell classification in peripheral blood	immunologic function(CD3?CD4?CD8)	8 months to baseline	No
Secondary	Erythrocyte Sedimentation Rata		once every month during the 8 months treatment period	Yes
Secondary	The cure rate will be evaluated as the primary parameter of efficacy		8-9 months	Yes
Secondary	The relapse in patients of both groups will be compared		at 12 months after the completion of the therapy	No