Study on Yang deficiency quality score and appropriate body surface temperature in people with Yang deficiency constitution improved by long-snake moxibustion

Registration number:

ITMCTR2100004946

Date of Last Refreshed on:

2021-06-12

Date of Registration:

2021-06-12

Registration Status:

Prospective registration

Public title:

Study on Yang deficiency quality score and appropriate body surface temperature in people with Yang deficiency constitution improved by long-snake moxibustion

English Acronym:

Scientific title:

Study on Yang deficiency quality score and appropriate body surface temperature in people with Yang deficiency constitution improved by long-snake moxibustion

Scientific title acronym:

Study subject ID:

江西省卫生健康委科技计划202140178

The registration number of the Partner Registry or other register:

ChiCTR2100047358 ; ChiMCTR2100004946

Applicant:

Huang Hui

Study leader:

Yang Yansha

Applicant telephone:

+86 17770034718

Study leader's telephone:

+86 18979157833

Applicant Fax:

Study leader's fax:

Applicant E-mail:

565024534@qq.com

Study leader's E-mail:

1147533601@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

264 Minde Road, Donghu District, Nanchang, Jiangxi

Study leader's address:

264 Minde Road, Donghu District, Nanchang, Jiangxi

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Nanchang Hongdu Hospital of TCM

Approved by ethic committee:

Approved No. of ethic committee:

KYKS-2020007

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of Nanchang Hongdu Hospital of TCM

Date of approved by ethic committee:

2020/8/13 0:00:00

Contact Name of the ethic committee:

Liu Xiaofang

Contact Address of the ethic committee:

1399 Diezihu Avenue, Honggutan New District, Nanchang, Jiangxi

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Nanchang Hongdu Hospital of TCM

Primary sponsor's address:

264 Minde Road, Donghu District, Nanchang, Jiangxi

Secondary sponsor:

Country:

China

Province:

Jiangxi

City:

Nanchang

Institution
hospital:

Nanchang Hongdu Hospital of TCM

Address:

264 Minde Road, Donghu District

Country:

China

Province:

Jiangxi

City:

Nanchang

Institution
hospital:

Nanchang Hongdu Hospital of TCM

Address:

1399 Diezihu Avenue, Honggutan New District

Source(s) of funding:

Health Commission of Jiangxi Province

Target disease:

Yang deficiency constitution

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

To observe the effect of long snake moxibustion on the Yang deficiency quality score of Yang deficiency people, and to explore the appropriate body surface temperature for regulating Yang deficiency by long snake moxibustion by monitoring the subject's body surface temperature during the treatment and analyzing the correlation with the therapeutic effect.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Aged 18-70 years, who meets the criteria for judging the constitution of Yang deficiency in ''Classification and Judgment of Traditional Chinese Medicine Constitution (ZYYXH/T157_2009)''; 2. Sign an informed consent form with the patient after the patient's informed consent; 3. Patients often live locally to ensure that treatment and follow-up can be completed.

Exclusion criteria:

1. Patients who are breastfeeding, pregnant or preparing to become pregnant; 2. Patients who have skin ulcers or rashes on the back, and those who suffer from infectious diseases; 3. Combined with serious primary diseases such as cardio-cerebrovascular and hematopoietic system; 4. Patients with mental illness; 5. Suspected or do have a history of alcohol or drug abuse; 6. Patients who have received long-snake moxibustion treatment or oral treatment with traditional Chinese medicine for nourishing yang within one month; 7. Patients who are participating in other drug clinical trials.

Study execute time:

From 2021-01-01

To      2022-12-31

Recruiting time:

From 2021-07-01

To      2021-12-31

Interventions:

30

Group:

Long Snake Moxibustion Group

Sample size:

Intervention:

Long Snake Moxibustion

Intervention code:

30

Group:

Infrared Group

Sample size:

Intervention:

Infrared

Intervention code:

Total sample size : 60

Countries of recruitment
and research settings:

Country:

China

Province:

Jiangxi

City:

Nanchang

Institution/hospital:

Nanchang Hongdu Hospital of TCM

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Body surface temperature at the application site

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

Yang deficiency constitution score

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Null

Tissue:

Fate of sample 

Others

Note:

Recruiting

18
Min age years
70
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Professional statisticians will number the included patients according to the order of visits, and use SPSS statistical software for random allocation. 60 subjects will be randomly arranged by the two groups. The balance of age, course of disease and disease degree of each group should be ensured.

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):

The data management and statistical analysis unit is responsible for the establishment of clinical data database and unified data management.

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

Case Record Form

Data Managemen Committee:

Not yet

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