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Pulmonary TuberculosisPhase 2NCT02313610

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

A Phase 2 study testing Qinbudan in people with Pulmonary Tuberculosis, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pulmonary Tuberculosis
What is being tested?
Qinbudan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
253 participants
Where
12 sitesChina
Study dates
Apr 2011to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Beijing chest hospital,Capital medical university

    Beijing, 101149

  • The first affiliated hospital of chongqing medical university

    Chongqing, 400042

  • Jiangxi provincial chest hospital

    Nanchang, Jiangxi, 330006

  • The 85th hospital of chinese people's liberation army

    Shanghai, 200052

  • Shanghai pulmonary hospital affiliated Tongji University

    Shanghai, 200433

  • Shenyang chest hospital

    Shenyang, Liaoning, 110044

  • Shenzhen Donghu hospital

    Shenzhen, 518112

  • Hebei provincial chest hospital

    Shijiazhuang, Hebei, 050041

  • Tianjin Haihe hospital

    Tianjin, 300350

  • Uygur Autonomous Region of Xinjiang Chest Hospital

    Ürümqi, Xinjiang, 830049

  • Wuhan tuberculosis dispensary

    Wuhan, Hubei, 430030

  • The first affiliated hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Qinbudan, Qinbudan Placebo
Keywords
Retreatment Pulmonary Tuberculosis, Qinbudan,
Medical subject headings
Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QinbudanDrug

    Also called Qinbudan table

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

  • Qinbudan PlaceboDrug

    Also called Qinbudan table Placebo

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

Study groups in NCT02313610
Study groupRoleWhat they receive
QinbudanExperimentalthe 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
Receives: Drug: Qinbudan
Control Qinbudan PlaceboPlacebo comparatorthe 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
Receives: Drug: Qinbudan Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Measured during the 8 months treatment period

Secondary outcomes (6)

  1. Time to resolution of all pulmonary tuberculosis symptoms

    Measured: 8 months

  2. Resolution of chest X-ray changes of patients

    Measured: 8 months to baseline

  3. T cell classification in peripheral blood

    immunologic function(CD3、CD4、CD8)

    Measured: 8 months to baseline

  4. Erythrocyte Sedimentation Rata

    Measured: once every month during the 8 months treatment period

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

    Measured: 8-9 months

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

    Measured: at 12 months after the completion of the therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2014 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313610
Sponsor's protocol ID
DS11036
Status last verified
Dec 2014
First submitted
7 Dec 2014
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32381098

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Qinbudan in people with Pulmonary Tuberculosis, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time of sputum conversion between the 2 groups will be evaluated (time frame: Measured during the 8 months treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.

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