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Study on the correlation between thermosensitive moxibustion efficiency and moxibustion effect in patients with allergic rhinitis stimulated by three different moxibustion techniques

Registration number：

ITMCTR2100004882

Date of Last Refreshed on：

2021-05-26

Date of Registration：

2021-05-26

Registration Status：

Prospective registration

Public title：

Study on the correlation between thermosensitive moxibustion efficiency and moxibustion effect in patients with allergic rhinitis stimulated by three different moxibustion techniques

English Acronym：

Scientific title：

Study on the correlation between thermosensitive moxibustion efficiency and moxibustion effect in patients with allergic rhinitis stimulated by three different moxibustion techniques

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100046660 ; ChiMCTR2100004882

Applicant：

Hua Fanghui

Study leader：

Xiong Jun

Applicant telephone：

+86 13970054277

Study leader's telephone：

+86 13970054277

Applicant Fax：

Study leader's fax：

Applicant E-mail：

178256362@qq.com

Study leader's E-mail：

xiongjun196071@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

56 Yangming Road, Donghu District, Nanchang, Jiangxi, China

Study leader's address：

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangxi University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

JZFYKYLL20210125007

Approved file of Ethical Committee：

Name of the ethic committee：

Medical Ethics Committee of Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Xiong Mingyi

Contact Address of the ethic committee：

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Primary sponsor's address：

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, China

Secondary sponsor：

Country：

China

Province：

Jiangxi

City：

Nanchang

Institution
hospital：

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Address：

445 Bayi Avenue, Donghu District

Source(s) of funding：

The project supported by Jiangxi University of Traditional Chinese Medicine Postgraduate Innovation Special Fund in 2020

Target disease：

Allergic rhinitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Main purpose: to explore the relationship between the three kinds of moxibustion techniques and the stimulation efficiency and moxibustion effect of heat-sensitive moxibustion, to provide scientific guidance and new ideas for the treatment of AR with heat-sensitive moxibustion, and to further supplement and improve the theory of heat-sensitive moxibustion system.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Aged 18 to 65 years, male or female; 2. It meets the Western medicine diagnostic criteria and Chinese medicine syndrome classification criteria of allergic rhinitis in this study; 3. Duration of disease >=1 year, and no acute attack within 2 weeks; 4. No adrenocortical hormones and other anti-allergic drugs were used within 2 weeks; 5. Patients voluntarily tested, normal mind, behavior, clear speech, can correctly express moxibustion feeling; 6. Agree to sign the informed consent.

Exclusion criteria：

1. Complicated with infective paranasinusitis, otitis media and other respiratory tract infections; 2. Nasal polyps or severe nasal septum deviation; 3. Patients with other types of rhinitis who failed to identify allergens; 4. Pregnant or lactating women; 5. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, as well as patients with severe mental disorders.

Study execute time：

From 2021-05-01

To      2022-05-01

Recruiting time：

From 2021-05-26

To      2022-02-01

Interventions：

40

Group：

Experimental group1

Sample size：

Intervention：

Bird pecking moxibustion

Intervention code：

40

Group：

Experimental group2

Sample size：

Intervention：

Convolute moxibustion

Intervention code：

40

Group：

Experimental group3

Sample size：

Intervention：

Swing moxibustion

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangxi

City：

Institution/hospital：

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Symptoms and signs score of allergic rhinitis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

No

Tissue：

Fate of sample 

Others

Note：

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 researchers used a table of random numbers to assign samples

Blinding：

Not stated

IPD sharing：

Yes

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

Not stated

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

CRF

Data Managemen Committee：

Not yet

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

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