Study on the Evolution of Traditional Chinese Medicine Syndromes and Their Association with Peripheral Blood Transcription Factors in Gout

Registration number:

ITMCTR2024000104

Date of Last Refreshed on:

2024-06-23

Date of Registration:

2024-06-23

Registration Status:

Prospective registration

Public title:

Study on the Evolution of Traditional Chinese Medicine Syndromes and Their Association with Peripheral Blood Transcription Factors in Gout

English Acronym:

ETCS-PBTFG

Scientific title:

The Evolution of Traditional Chinese Medicine Syndromes and Their Association with Peripheral Blood Transcription Factors in Gout

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

Xiaopeng Fu

Study leader:

Xiaopeng Fu

Applicant telephone:

+86 13250713598

Study leader's telephone:

+86 13250713598

Applicant Fax:

Study leader's fax:

Applicant E-mail:

1220105011@fjtcm.edu.cn

Study leader's E-mail:

1220105011@fjtcm.edu.cn

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

350122

Study leader's address:

350122

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Fujian University of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2024KS-70-1

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of the Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Date of approved by ethic committee:

2024/5/30 0:00:00

Contact Name of the ethic committee:

Zhan Lu

Contact Address of the ethic committee:

363 Guobin Avenue, Minhou Shangjie, Minhou County, Fuzhou City

Contact phone of the ethic committee:

+86 591 2286 7120

Contact email of the ethic committee:

fjsykjk@126.com

Primary sponsor:

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Primary sponsor's address:

363 Guobin Avenue, Minhou Shangjie, Minhou County, Fuzhou City

Secondary sponsor:

Country:

China

Province:

Fujian

City:

Fuzhou

Institution
hospital:

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Address:

363 Guobin Avenue, Minhou Shangjie, Minhou County, Fuzhou City

Source(s) of funding:

Other projects and self-funding of this unit

M10

Target disease:

Gout

Target disease code:

Study type:

Observational study

Study design:

Cross-sectional

Study phase:

Others

Objectives of Study:

This study aims to explore the evolution patterns of Traditional Chinese Medicine (TCM) syndromes in gout patients and their association with peripheral blood transcription factors. By systematically investigating the distribution of TCM syndromes and their correlation with local symptoms and micro indicators at different stages of gout, and using multivariate statistical methods such as principal component analysis and factor analysis, the study will summarize the syndrome evolution patterns of gout. The results will provide scientific evidence for TCM diagnosis and treatment of gout, propose relevant TCM treatment suggestions and syndrome evolution models, and promote the application and development of TCM in gout treatment.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

①Patients in the preclinical and clinical stages of gout according to the aforementioned diagnostic criteria. ②Age between 18 and 65 years. ③For the prospective study part, patients must be informed and consent voluntarily to participate in this clinical investigation and sign the informed consent form. For the retrospective study part, existing medical records can be used for analysis.

Exclusion criteria:

①Patients who do not meet the aforementioned inclusion criteria. ②Patients with severe disease in major organs or with psychiatric disorders that might affect the study results or patient safety. ③Patients who refuse to cooperate with the study. ④Incomplete medical records, making it impossible to ensure the completeness and accuracy of the study data.

Study execute time:

From 2024-06-25

To      2025-02-28

Recruiting time:

From 2024-06-25

To      2025-02-28

Interventions:

60

Group:

Gout Group A (Preclinical Stage)

Sample size:

Intervention:

None

Intervention code:

60

Group:

Group:Gout Group C (Chronic Stage)

Sample size:

Intervention:

None

Intervention code:

60

Group:

Gout Group B (Acute Stage)

Sample size:

NA

Intervention:

NA

Intervention code:

60

Group:

Medication Intervention Group

Sample size:

Intervention:

Traditional Chinese Medicine formula

Intervention code:

Total sample size : 240

Countries of recruitment
and research settings:

Country:

China

Province:

Fujian

City:

Fuzhou

Institution/hospital:

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Information on four TCM diagnoses

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Peripheral Blood Transcription Factors

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Lifestyle

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Basic information of clinical parameters

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Blood

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Blood

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):

N/A

Blinding:

IPD sharing:

No

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

None

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