A randomized double-blind placebo-controlled study of Qingfei Jianpi desensitization prescription in early intervention of seasonal allergic rhinitis

Registration number:

ITMCTR2200006028

Date of Last Refreshed on:

2022-05-22

Date of Registration:

2022-05-22

Registration Status:

Prospective registration

Public title:

A randomized double-blind placebo-controlled study of Qingfei Jianpi desensitization prescription in early intervention of seasonal allergic rhinitis

English Acronym:

Scientific title:

A randomized double-blind placebo-controlled study of Qingfei Jianpi desensitization prescription in early intervention of seasonal allergic rhinitis

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200060198 ; ChiMCTR2200006028

Applicant:

qujing

Study leader:

qujing

Applicant telephone:

58268082

Study leader's telephone:

58268082

Applicant Fax:

Study leader's fax:

Applicant E-mail:

erqjaa@126.com

Study leader's E-mail:

erqjaa@126.com

Study leader's website(voluntary supply):

北京同仁医院

Study leader's website
(voluntary supply):

Applicant address:

DongjiaoMinxiangNo.1,DongchengDistrict,Beijing

Study leader's address:

DongjiaoMinxiangNo.1,DongchengDistrict,Beijing

Applicant postcode:

Study leader's postcode:

Applicant's institution:

BeijingTongrenHospital,Capital Medical University

Approved by ethic committee:

Approved No. of ethic committee:

TREC2022-KY001.R1

Approved file of Ethical Committee:

View

Name of the ethic committee:

Beijing Tongren Hospital Capital Medical University Approved ethic committee

Date of approved by ethic committee:

2022/3/17 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Beijing Tongren Hospital ,Capital Medical University

Primary sponsor's address:

Beijing Tongren Hospital, Dongjiao Minxiang No. 1, Dongcheng District, Beijing

Secondary sponsor:

Country:

china

Province:

beijing

City:

Institution
hospital:

BeijingTongrenHospital,CapitalMedicalUniversity

Address:

DongjiaoMinxiangNo.1,DongchengDistrict,Beijing

Source(s) of funding:

Capital Health Development Scientific Research Project

Target disease:

allergic rhinitis

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

This study is expected to confirm the effectiveness of Qingfei Jianpi desensitization formula in the preventive treatment of seasonal allergic rhinitis, its impact on the symptoms, nasal function and immune factors of nasal secretion in the whole pollen period, improve the research on the early intervention of traditional Chinese medicine in seasonal allergic rhinitis, and carry forward the advantages and characteristics of Yanjing school's "gypsum kong" in the treatment of nasal diseases.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(1) Patients who meet the diagnostic criteria of Western medicine and TCM syndrome differentiation criteria; (2) At least 2 years in the same season, the onset season of each year is basically the same, and it is consistent with the pollination period of sensitized pollen; (3) The age ranged from 18 to 65 years; (4)Voluntarily participate in this experimental study and voluntarily terminate all treatments that may affect the evaluation of the tested drug; (5)Sign informed consent

Exclusion criteria:

(1)Those who have taken steroids in recent 2 weeks and antihistamines or topical steroids in 1 week; (2)Perennial allergic rhinitis, acute rhinitis, or severe asthma combined with severe nasal septum deviation and hypertrophic rhinitis; (3)Patients with serious primary diseases and psychosis such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; (4)Allergic to the drug; (5)A woman who is pregnant, lactating or preparing for pregnancy.

Study execute time:

From 2022-01-01

To      2024-12-31

Recruiting time:

From 2022-07-01

To      2024-11-01

Interventions:

40

Group:

Experimental group

Sample size:

Intervention:

placebo

Intervention code:

40

Group:

Experimental group

Sample size:

Intervention:

Qingfei Jianpi desensitization

Intervention code:

Total sample size : 80

Countries of recruitment
and research settings:

Country:

CHINA

Province:

Beijing

City:

Institution/hospital:

Beijing Tongren Hospital ,Capital Medical University

Level of the institution:

Third Grade First Class

Outcomes:

Outcome:

nasal resistance

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

TCM syndrome score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Nasal sound reflection

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Symptom score

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

RQLQ score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Nasal secretion

Tissue:

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

The data personnel of Beijing Institute of Ophthalmology used statistical software to generate random sequences

Blinding:

IPD sharing:

No

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

After the trial is completed and the paper is published, it will be published on the website of China clinical trial registration center

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

Data collection is collected by clinical researchers with CRF, and EpiData database is established for input and data statistics

Data Managemen Committee:

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above