NCT06373692

Brief Summary

The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.

Trial Health

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Trial Health Score

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Enrollment
1,508

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
May 2024Dec 2026

First Submitted

Initial submission to the registry

January 3, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

January 3, 2024

Last Update Submit

April 15, 2024

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaAsthma control rateNumber of acute attacksCohort studies

Outcome Measures

Primary Outcomes (1)

  • Asthma control rate

    According to the composite indicators such as symptoms, medication and pulmonary function test results, the clinical control level of asthma was divided into complete control, partial control and uncontrolled, and the asthma control rate of patients was evaluated according to the clinical control level of asthma.

    The follow-up period was followed up every 3 months for 1 year.

Secondary Outcomes (12)

  • Number of exacerbations

    The follow-up period was followed up every 3 months for 1 year.

  • Asthma exacerbation severity

    The follow-up period was followed up every 3 months for 1 year.

  • Change in severity of chronic persistent disease

    The follow-up period was followed up every 3 months for 1 year.

  • The dose used by glucocorticoids

    The follow-up period was followed up every 3 months for 1 year.

  • Rapid-acting beta2 agonists use drugs and doses

    The follow-up period was followed up every 3 months for 1 year.

  • +7 more secondary outcomes

Study Arms (2)

Traditional Chinese Medical cohort

The standardized use of TCM treatment regimen was regarded as an exposure factor, and the treatment methods of the enrolled patients were defined and grouped: patients who took medication continuously for more than 3 months per year, or who took medication intermittently for more than 6 months in the total time of the year, were in the exposure group.

Non Traditional Chinese Medical cohort

Those who used conventional Western medicine treatment without using standardized Chinese medicine treatment regimen were in the non-exposure group.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are eligible for a diagnosis of bronchial asthma disease

You may qualify if:

  • Patients who meet the diagnosis of bronchial asthma;
  • Age 18\~80 years old;
  • Have not participated in other clinical studies within 1 month before enrollment;
  • Voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

  • Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
  • Delirium, impaired consciousness, dementia, and various mental illnesses;
  • Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
  • Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
  • Pregnant and lactating patients;
  • Those who are participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biological samples include serum samples, plasma samples, urine samples, sputum samples, and exhaled air condensate samples.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jian-sheng Li, Professor

    The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Hai-bin Yu, Ph.D

CONTACT

+86 13526671773wwz1231125@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2024

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)