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Clinical study of "lung and nose treatment together" in the treatment of children with Combined allergic rhinitis and asthma syndrome（CARAS）

Registration number：

ITMCTR2024000336

Date of Last Refreshed on：

2024-08-31

Date of Registration：

2024-08-31

Registration Status：

Retrospective registration

Public title：

Clinical study of "lung and nose treatment together" in the treatment of children with Combined allergic rhinitis and asthma syndrome（CARAS）

English Acronym：

Scientific title：

Clinical study of "lung and nose treatment together" in the treatment of children with Combined allergic rhinitis and asthma syndrome（CARAS）

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wang Zhuiyue

Study leader：

Xue Zheng

Applicant telephone：

18614981912

Study leader's telephone：

18621905133

Applicant Fax：

Study leader's fax：

Applicant E-mail：

826558435@qq.com

Study leader's E-mail：

xuezheng@shutcm.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.274, Zhijiang Road, Jing'an District, Shanghai, China.

Study leader's address：

No.274, Zhijiang Road, Jing'an District, Shanghai, China.

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022SHL-KY-55-03

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Shanghai Traditional Chinese Medicine Hospital

Date of approved by ethic committee：

2024/7/23 0:00:00

Contact Name of the ethic committee：

Ling Li

Contact Address of the ethic committee：

No.274, Zhijiang Road, Jing'an District, Shanghai, China.

Contact phone of the ethic committee：

021-56628310

Contact email of the ethic committee：

shszyyyec@126.com

Primary sponsor：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No.274, Zhijiang Road, Jing'an District, Shanghai, China.

Secondary sponsor：

Country：

CHINA

Province：

Shanghai

City：

Institution
hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address：

No.274, Zhijiang Road, Jing'an District, Shanghai, China.

Source(s) of funding：

Science and Technology Commission of Shanghai Municipality

Target disease：

combined allergic rhinitis and asthma syndrome

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

By means of multi-center, randomized, double-blind and parallel controlled studies, high-level clinical evidence of traditional Chinese medicine in the treatment of children with allergic rhinitis and asthma syndrome was formed. so as to provide a basis for clinical treatment of children's CARAS.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) The patients were 6-11 years old (< 12 years old), male or female, and came from the outpatient department. (2) The diagnostic criteria of CARAS in children were in accordance with the "Recommendations for the Standardized diagnosis and Treatment of Bronchial Asthma in Children (2020)" and the "Guidelines for the diagnosis and treatment of allergic rhinitis in Children (2022, Revised edition)". (3) Rhinitis was mild AR or intermittent moderate to severe AR; Asthma was in the non-acute stage, and the condition was mild persistent (level 2) and moderate persistent (level 3). (4) in accordance with the TCM syndrome of pathogenic wind invading the lung; (5) in accordance with the provisions of informed consent.

Exclusion criteria：

(1) children with nasal septum curvature, nasal polyps, sinusitis, abnormal nasal anatomy or other respiratory diseases; (2) other diseases causing asthma or dyspnea; (3) Patients with inadequate washout period before enrollment: ① patients received immunotherapy within 1 month; ② Systemic use of glucocorticoids within 2 weeks; ④ Systemic use of leukotriene receptor antagonists, theophyllines, or long-acting anticholinergic drugs within one week; ③ Systemic use of antihistamines within 5 days; ⑤ use of nasal decongestants and antihistamines within 3 days; (4) combined with cardiovascular and cerebrovascular diseases, hematopoietic system diseases, or serious diseases of other organs, such as heart, liver, kidney and other diseases; (5) patients with mental disorders, severe malnutrition and rickets; (6) patients with known allergies to the drugs used in this study (7)Any situation that the investigator believes would compromise patient safety or data quality.

Study execute time：

From 2022-07-01

To      2025-06-30

Recruiting time：

From 2024-08-10

To      2025-05-30

Interventions：

154

Group：

experimental group

Sample size：

Intervention：

Mometasone furoate nasal spray + budesonide/formoterol powder inhalation + Tongqiao Pingchuan decoction granules orally

Intervention code：

154

Group：

control group

Sample size：

Intervention：

Mometasone furoate nasal spray + inhalation of budesonide/formoterol powder inhalation + oral Tongqiao Pingchuan decoction granule mimics

Intervention code：

Total sample size ： 308

Countries of recruitment
and research settings：

Country：

China

Province：

shanghai

City：

Institution/hospital：

Shanghai Baoshan Hospital of integarted Traditional Chinese and Western Medicine

Level of the institution：

top three hospitals

Country：

CHINA

Province：

Shanghai

City：

Institution/hospital：

Children's Hospital of Shanghai

Level of the institution：

top three hospitals

Country：

CHINA

Province：

Shanghai

City：

Institution/hospital：

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Level of the institution：

top three hospitals

Country：

CHINA

Province：

Shanghai

City：

Institution/hospital：

Shanghai Children's Medical Center

Level of the institution：

top three hospitals

Country：

CHINA

Province：

Shanghai

City：

Institution/hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Level of the institution：

top three hospitals

Country：

CHIAN

Province：

Shanghai

City：

Institution/hospital：

Longhua Hospital Shanghai University of Traditional Chinese and Medicine

Level of the institution：

top three hospitals

Country：

CHINA

Province：

Shanghai

City：

Institution/hospital：

Shanghai Seventh People's Hospital

Level of the institution：

top three hospitals

Outcomes：

Outcome：

renal function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Symptoms of asthma exacerbations were recorded

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

urine routines

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

vital signs

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Percentage of eosinophils

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The C-ACT test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood RT

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

lung function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cumulative drug dosage

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM single symptom and syndrome scores

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The TNSS test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Electrocardiograph

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

FnNO

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The CARATkids test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

CRP

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

6
Min age years
11
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

With the help of SPSS25.0 statistical software, 308 children were divided into experimental group and control group by block randomization method

Blinding：

IPD sharing：

No

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

Raw data are not shared

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

The study cases were used for data collection, and the computer software CDMS was used for data management

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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