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A study on the epidemiology of cough-related respiratory diseases in children in the Northeast and Central-South regions and the characteristics of Chinese medicine syndromes

Registration number：

ITMCTR2024000801

Date of Last Refreshed on：

2024-12-11

Date of Registration：

2024-12-11

Registration Status：

Prospective registration

Public title：

A study on the epidemiology of cough-related respiratory diseases in children in the Northeast and Central-South regions and the characteristics of Chinese medicine syndromes

English Acronym：

Scientific title：

A study on the epidemiology of cough-related respiratory diseases in children in the Northeast and Central-South regions and the characteristics of Chinese medicine syndromes

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Liu Qian

Study leader：

WANG Xuefeng

Applicant telephone：

18365701169

Study leader's telephone：

13840208807

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1366528484@qq.com

Study leader's E-mail：

lnzywxf@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.33 Beiling Street Huanggu District Shenyang Liaoning Province

Study leader's address：

No.33 Beiling Street Huanggu District Shenyang Liaoning Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024087CS(KT)-036-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/10/31 0:00:00

Contact Name of the ethic committee：

Li Xiao

Contact Address of the ethic committee：

Research Building No. 72 Chongshan Dong Road Huanggu District Shenyang Liaoning Province China

Contact phone of the ethic committee：

024-82961989

Contact email of the ethic committee：

lnzyllb@163.com

Primary sponsor：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Primary sponsor's address：

No.33 Beiling Street Huanggu District Shenyang Liaoning Province China

Secondary sponsor：

Country：

China

Province：

Liaoning Province

City：

Shenyang prefecture level city

Institution
hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Address：

No.33 Beiling Street Huanggu District Shenyang Liaoning Province China

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Acute tracheo-bronchitis cough variant asthma

Target disease code：

Study type：

Epidemilogical research

Study design：

Cross-sectional

Study phase：

Others

Objectives of Study：

1. to investigate the proportion of acute tracheo-bronchitis and cough variant asthma among all study subjects; 2. to investigate the proportion of common symptoms in children's respiratory diseases and the proportion of people with respiratory with digestive system symptoms among all people with respiratory symptoms; 3. to investigate the characteristics of Chinese medicine symptoms of cough-related respiratory diseases.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Age 0-14 years (≤14 years) no gender restriction; 2. Cough is the main complaint; 3. the disease is respiratory system disease. Those who do not fulfill one of the above conditions shall not be selected as subjects.

Exclusion criteria：

Studies were excluded if they met any of the following criteria: 1.Incomplete information in patients' medical records; 2. those who in the opinion of the principal investigator and/or co-investigators are not suitable for participation in this study.

Study execute time：

From 2024-06-01

To      2025-06-30

Recruiting time：

From 2024-12-15

To      2025-06-30

Interventions：

2000

Group：

Observation group

Sample size：

Intervention：

None

Intervention code：

Total sample size ： 2000

Countries of recruitment
and research settings：

Country：

China

Province：

Guangxi Zhuang Autonomous Region

City：

Tiandong county

Institution/hospital：

Tiandong County Chinese Medicine Hospital

Level of the institution：

grade 2A

Country：

China

Province：

Henan Province

City：

Xiangcheng prefecture level city

Institution/hospital：

Xiangcheng First People's Hospital

Level of the institution：

grade 2A

Country：

China

Province：

Guangxi Zhuang Autonomous Region

City：

Yulin prefecture level city

Institution/hospital：

Yulin First People's Hospital

Level of the institution：

grade 3A

Country：

China

Province：

Liaoning Province

City：

Shenyang prefecture level city

Institution/hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

grade 3A

Country：

China

Province：

Henan Province

City：

Nanyang prefecture level city

Institution/hospital：

Nanyang City Center Hospital

Level of the institution：

grade 3A

Country：

China

Province：

Henan Province

City：

Zhengzhou prefecture level city

Institution/hospital：

The First Affiliated Hospital of Zhengzhou University

Level of the institution：

grade 3A

Country：

China

Province：

Hubei Province

City：

Wuhan prefecture level city

Institution/hospital：

Wuhan Children's Hospital Tongji Medical College Huazhong University of Science and Technology China

Level of the institution：

grade 3A

Country：

China

Province：

Hubei Province

City：

Wuhan prefecture level city

Institution/hospital：

Union Hospital Tongji Medical College Huazhong University of Science and Technology China

Level of the institution：

grade 3A

Country：

China

Province：

Hubei Province

City：

Huanggang prefecture level city

Institution/hospital：

Huangzhou District People's Hospital

Level of the institution：

grade 2A

Outcomes：

Outcome：

Laboratory tests

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Disease diagnosis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Basic Information

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chinese Medicine Symptoms

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Use of medication

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

No collection of human specimens

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

0
Min age years
14
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study was a retrospective study and all eligible patients were enrolled.

Blinding：

IPD sharing：

No

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

No Shared

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

Case Record Form and Electronic Data Capture

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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