REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bronchial Asthma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.
This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.
Primary outcome measures
- Asthma control rate [Time frame: The follow-up period was followed up every 3 months for 1 year.]
Secondary outcome measures (12)
- Number of exacerbations [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Asthma exacerbation severity [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Change in severity of chronic persistent disease [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- The dose used by glucocorticoids [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Rapid-acting beta2 agonists use drugs and doses [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Control Test (ACT) score [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Control Questionnaire (ACQ) [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Quality of Life Score (AQLQ) [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Anxiety Self-Assessment Form (SAS) [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Depression Self-Rating Scale (SDS) [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Pulmonary function [Time frame: The follow-up period was followed up every 3 months for 1 year.]
- Exhaled nitric oxide (FeNO) [Time frame: The follow-up period was followed up every 3 months for 1 year.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT06373692 · TCM for Asthma Cohort