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A cohort study on the spatio-temporal evolution pattern and representational biology of bronchial asthma evidence in traditional Chinese medicine

Registration number：

ITMCTR2024000772

Date of Last Refreshed on：

2024-12-03

Date of Registration：

2024-12-03

Registration Status：

Prospective registration

Public title：

A cohort study on the spatio-temporal evolution pattern and representational biology of bronchial asthma evidence in traditional Chinese medicine

English Acronym：

BioSTEP Study

Scientific title：

A cohort study on the spatio-temporal evolution pattern and representational biology of bronchial asthma evidence in traditional Chinese medicine

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Fan Feiting

Study leader：

Chen Yuanbin

Applicant telephone：

13925040131

Study leader's telephone：

15920174645

Applicant Fax：

Study leader's fax：

Applicant E-mail：

fft41@163.com

Study leader's E-mail：

chenyuanbin110@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 111 Dade Road Guangzhou Guangdong Province China

Study leader's address：

No. 111 Dade Road Guangzhou Guangdong Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangdong Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

BE2024-306-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/11/1 0:00:00

Contact Name of the ethic committee：

Li Xiaoyan

Contact Address of the ethic committee：

No. 111 Dade Road Guangzhou Guangdong Province China

Contact phone of the ethic committee：

020-81887233

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

Primary sponsor：

Guangdong Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No. 111 Dade Road Guangzhou Guangdong Province China

Secondary sponsor：

Country：

China

Province：

Guangdong Province

City：

Institution
hospital：

Guangdong Hospital of Traditional Chinese Medicine

Address：

No. 111 Dade Road Guangzhou Guangdong Province China

Source(s) of funding：

the State Key Laboratory of Dampness Syndrome of Chinese Medicine (Grant no. SZ2021ZZ42)

Target disease：

bronchial asthma

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Others

Objectives of Study：

1. To conduct a national multi-centre prospective large-scale cohort study on bronchial asthma to explore the temporal and spatial evolution of Chinese medicine symptoms risk factors and outcome regression in the course of bronchial asthma; to integrate Chinese and Western medicine multi-source heterogeneous data to construct a risk prediction model for acute asthma exacerbation. 2. Collect sputum and blood samples from bronchial asthma patients regularly according to the visit scheduled; analyse the multidimensional biological indicators and potential biomarkers related to the symptoms during the disease process and explore the nature of the symptoms under the evolution of Chinese medicine symptoms in bronchial asthma and the potential targets of drug intervention.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) 18 years old ≤ age <75 years old male and female; (2)Meet the diagnostic criteria of bronchial asthma or healthy people; (3) Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria：

(1) Combination of other serious lung diseases such as bronchiectasis chronic pulmonary heart disease lung malignancy interstitial fibrosis active tuberculosis eosinophilic pneumonia and so on; (2) Combination of autoimmune diseases such as rheumatoid lupus erythematosus and other unstable conditions; 3）Combination of parasitic infection exfoliative dermatitis aspergillosis scarlet fever chronic granulocytic leukaemia Hodgkin's disease chronic adrenocortical hypoplasia and other diseases that can cause elevated serum eosinophils; (4) Combination of pulmonary aspergillosis high IgE syndrome IgE type multiple myeloma and other diseases that can cause elevation of total serum IgE; (5) Combined with other organs (such as heart brain liver kidney etc.) more serious primary diseases or malignant tumours; (6) Patients with mental illness or other reasons for not being able to co-operate.

Study execute time：

From 2024-12-05

To      2026-12-05

Recruiting time：

From 2024-12-05

To      2026-12-05

Interventions：

500

Group：

Allergic Asthma Group

Sample size：

Intervention：

None

Intervention code：

500

Group：

Non-allergic asthma group

Sample size：

Intervention：

None

Intervention code：

50

Group：

health group

Sample size：

Intervention：

None

Intervention code：

Total sample size ： 1050

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

The Third People's Hospital of Huizhou

Level of the institution：

Participating unit

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Dongguan Hospital of Integrative Medicine

Level of the institution：

Participating unit

Country：

China

Province：

Hunan Province

City：

Institution/hospital：

Hunan Provincial Central Hospital

Level of the institution：

Participating unit

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Zhanjiang No.2 Chinese Medicine Hospital

Level of the institution：

Participating unit

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Zhongshan Hospital of Traditional Chinese Medicine

Level of the institution：

Participating unit

Country：

China

Province：

Shandong Province

City：

Institution/hospital：

Yantai Hospital of Traditional Chinese Medicine Shandong Province

Level of the institution：

Participating unit

Country：

China

Province：

Xichuan Province

City：

Institution/hospital：

Chengdu Combined Traditional Chinese and Western Medicine Hospital

Level of the institution：

Participating unit

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Guangdong Hospital of Traditional Chinese Medicine

Level of the institution：

Trial organiser

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Guangzhou Panyu District Hospital of Traditional Chinese Medicine

Level of the institution：

Participating unit

Country：

China

Province：

Guangdong Province

City：

Institution/hospital：

Guangzhou Baiyun District Second People's Hospital

Level of the institution：

Participating unit

Outcomes：

Outcome：

Lung function indicators

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PHQ-9

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

ACT scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

GAD-7

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Information Collection Form for Four Consultations of Chinese Medicine Practitioners

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

eosinophil count

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chinese Medicine Dampness Assessment Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Information Collection Form for Core Symptoms of Dampness in Chinese Medicine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chinese Medicine Body Mass Chart

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Total IgE concentration

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Allergen indicators

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

plasma

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

serum

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

sputum

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not need to random

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The data is not shared and will be published in the form of a paper

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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