REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenan University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients who are eligible for a diagnosis of bronchial asthma disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,508 Participants
are grouped into 2 trial groups
Group A: Traditional Chinese Medical cohort
Group B: Non Traditional Chinese Medical cohort

Trial outcomes

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.

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

Secondary outcomes

1

Number of exacerbations

The number of acute attacks is mainly recorded

Time frame
The follow-up period was followed up every 3 months for 1 year.
2

Asthma exacerbation severity

Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale.

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

Change in severity of chronic persistent disease

Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale.

Time frame
The follow-up period was followed up every 3 months for 1 year.
4

The dose used by glucocorticoids

Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day).

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

Other outcomes

Sponsors and contacts

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Henan University of Traditional Chinese Medicine

Lead sponsor

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

Tianjin University of Traditional Chinese Medicine

Collaborator

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

Hebei Provincial Hospital of Traditional Chinese Medicine

Collaborator

Peking University People's Hospital

Collaborator

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaborator

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