Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma

NCT ID: NCT04128111

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2022-12-31

Brief Summary

This study aims to determine the TCM syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between TCM syndrome and inflammation phenotype. Secondly screening biomarkers that can be recognized by TCM syndromes and inflammatory phenotypes of bronchial asthma, and provide a basis for individualized diagnosis and treatment of diseases.

Detailed Description

The clinical heterogeneity of bronchial asthma was strong.The TCM syndrome was complicated and mostly treated on stage, type, excess and deficiency.The phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.The flammatory phenotype was the more common type.The pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as Airway eosinophil cells, so it was important to find the specific biomarker. The correlation between TCM syndrome, inflammatory phenotype and its biomarker wsa not clear. So we put forward theoretical hypothesis:There was of correlation between TCM syndrome and inflammatory phenotype of asthma.The biological target was contributes to the confirmation for TCM syndrome and inflammatory phenotype.The following research was planned to be carried out: relying on the registration system of National TCM Clinical Research Base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, TCM syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. Based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.The research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.

Conditions

Bronchial Asthma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Acute Exacerbation

Exacerbations of asthma are episodes characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e. they represent a change from the patient's usual status that is sufficient to require a change in treatment.

No interventions assigned to this group

Non-acute exacerbation

Non-acute exacerbation of asthma includes chronic remission and clinical delays.Clinical remission stage refers to an absence of wheezing, chest tightness, cough and other symptoms for more than 1 year.Chronic duration refers to that symptoms, such as wheezing, chest tightness, cough and so on, attack at different frequency and different degrees every week.

No interventions assigned to this group

Healthy Volunteer

Health is not only the absence of disease or infirmity, but also a state of physical, mental, and social perfection.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients with definite dignosis of bronchial asthma or healthy volunteer;

2. Ages range from 18 years to 80 years old;

3. Not anticipated in other clinical studies within 1 month before enrollment;

4. Signed informed consent.

Exclusion Criteria

1. Acute asthma exacerbation patients with respiratory failure, mechanical ventilation;

2. Patients with unconsciousness, dementia, various mental disorders;

3. Complicated with hematological malignancies , heart failure(Acute myocardial infarction, cardiac function grade 3 or above), severe liver or kidney diseases;

4. Complicated with neuromuscular disorders affecting respiratory and motor function, unable to complete the six-minute walk test;

5. People who are participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suyun Li, Professor

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Henan University of Chinese Medicine

Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mihang Wang, Professor

Role: CONTACT

wmh107hn@163.com

86-371-66248624

Facility Contacts

Minghang Wang, Professor

Role: primary

wmh107hn@163.com

86-371-66248624

Other Identifiers

TCM syndrome of Asthma

Identifier Type: -

Identifier Source: org_study_id