Skip to main content
OpenTrials
Completed

NCT Number: NCT02313610

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hebei provincial chest hospital, Shijiazhuang, Hebei, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qinbudan

Drug

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

Other names: Qinbudan table

Qinbudan Placebo

Drug

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

Other names: Qinbudan table Placebo

Primary outcomes

  1. The time of sputum conversion between the 2 groups will be evaluated

    Time frame: Measured during the 8 months treatment period

Secondary outcomes

  1. Time to resolution of all pulmonary tuberculosis symptoms

    Time frame: 8 months

  2. Resolution of chest X-ray changes of patients

    Time frame: 8 months to baseline

  3. T cell classification in peripheral blood

    Time frame: 8 months to baseline

    immunologic function(CD3、CD4、CD8)

  4. Erythrocyte Sedimentation Rata

    Time frame: once every month during the 8 months treatment period

  5. The cure rate will be evaluated as the primary parameter of efficacy

    Time frame: 8-9 months

  6. The relapse in patients of both groups will be compared

    Time frame: at 12 months after the completion of the therapy

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2014
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.