湿疹发病机制及维吾尔医特色疗法诊疗机制研究

注册号:

Registration number:

ITMCTR2024000501

最近更新日期:

Date of Last Refreshed on:

2024-09-29

注册时间:

Date of Registration:

2024-09-29

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

湿疹发病机制及维吾尔医特色疗法诊疗机制研究

Public title:

Research on the Pathogenesis of Eczema and the Diagnostic and Therapeutic Mechanisms of Uighur Medicine

注册题目简写:

English Acronym:

研究课题的正式科学名称:

湿疹发病机理与维吾尔医学特色治疗机制研究

Scientific title:

Study on the Pathogenesis of Eczema and the Therapeutic Mechanisms of Uighur Medicine

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

居来提·阿不都瓦衣提

研究负责人:

李治建

Applicant:

Julaiti Abuduwaiti

Study leader:

Li Zhi jian

申请注册联系人电话:

Applicant telephone:

13579947760

研究负责人电话:

Study leader's telephone:

15981799975

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

68521380@qq.com

研究负责人电子邮件:

Study leader's E-mail:

lizhijian0220@sina.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

申请注册联系人通讯地址:

乌鲁木齐市天山区延安路776号

研究负责人通讯地址:

乌鲁木齐市天山区延安路776号

Applicant address:

No. 776 Yan'an Road, Tianshan District, Urumqi City

Study leader's address:

No. 776 Yan'an Road, Tianshan District, Urumqi City

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

新疆维吾尔自治区维吾尔医医院

Applicant's institution:

Xinjiang Uyghur Autonomous Region Uyghur Medical Hospita Affiliation

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022TSYCLJ0009

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

新疆维吾尔自治区维吾尔医医院伦理委员会

Name of the ethic committee:

Ethics Committee of Xinjiang Uyghur Medical Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023/12/1 0:00:00

伦理委员会联系人:

阿丽耶

Contact Name of the ethic committee:

Aliye

伦理委员会联系地址:

乌鲁木齐市天山区延安路776号

Contact Address of the ethic committee:

No. 776 Yan'an Road, Tianshan District, Urumqi City

伦理委员会联系人电话:

Contact phone of the ethic committee:

13999134672

伦理委员会联系人邮箱:

Contact email of the ethic committee:

40200756@qq.com

研究实施负责(组长)单位:

新疆维吾尔自治区维吾尔医医院

Primary sponsor:

Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital

研究实施负责(组长)单位地址:

乌鲁木齐市天山区延安路776号

Primary sponsor's address:

No. 776 Yan'an Road, Tianshan District, Urumqi City

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

新疆

市(区县):

乌鲁木齐

Country:

China

Province:

Xinjiang

City:

Urumqi

单位(医院):

新疆维吾尔自治区维吾尔医医院

具体地址:

乌鲁木齐市天山区延安路776号

Institution
hospital:

Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital

Address:

No. 776 Yan'an Road, Tianshan District, Urumqi City

经费或物资来源:

国家中医药管理局

Source(s) of funding:

State Administration of Traditional Chinese Medicine

研究疾病:

湿疹

研究疾病代码:

Target disease:

Eczema.

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究旨在深入探索湿疹的发病机制及维吾尔医特色疗法的诊疗机制。具体来说,通过单细胞测序技术,系统分析湿疹患者皮肤病变区和正常皮肤的细胞组成和基因表达特征,以揭示湿疹发病的分子机制及其背后的免疫调节过程;利用多组学分析方法,深入理解维吾尔医特色疗法在湿疹治疗中的作用机制,尝试揭示维吾尔医特色疗法如何影响湿疹的发病机制和病理生理过程,是否能够调节免疫系统、恢复色素细胞功能或者影响其他关键生物过程。这种研究有助于验证维吾尔医特色疗法的有效性,并为其在湿疹个体化治疗中的应用提供科学依据。

Objectives of Study:

This study aims to explore in depth the pathogenesis of eczema and the diagnostic and therapeutic mechanisms of Uighur medicine. Specifically, through single-cell sequencing technology, it systematically analyzes the cellular composition and gene expression profiles of lesional and normal skin tissues from eczema patients, aiming to uncover the molecular mechanisms underlying eczema pathogenesis and the associated immune regulation processes. By employing multi-omics analysis methods, the study seeks to gain deeper insights into the mechanisms through which Uighur medicine exerts its effects in eczema treatment. It aims to elucidate how Uighur medicine may influence the pathogenesis and pathophysiology of eczema, including its potential effects on immune modulation, restoration of melanocyte function, or impact on other critical biological processes. This research is expected to contribute to validating the efficacy of Uighur medicine and providing scientific evidence for its personalized application in eczema treatment.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合西医和维吾尔医诊断标准; (2)治疗前 4 周内未使用糖皮质类激素、抗组胺药和其他外用药物; (3)性别不限,年龄18~65岁; (4)亚急性期和慢性期湿疹患者; (5)签署知情同意书,配合治疗。

Inclusion criteria

(1)Meets the diagnostic criteria of Western medicine and traditional Uyghur medicine; (2)No use of glucocorticoids antihistamines or other topical medications in the 4 weeks prior to treatment; (3)No gender restriction age 18 to 65 years; (4)Patients with subacute and chronic eczema; (5)Signed informed consent and willingness to cooperate with treatment.

排除标准:

(1)合并有严重的心血管、肺部、肝脏、肾脏、胃肠道、造血系统、 内分泌系统等疾病及精神疾病患者; (2)损部位合并真菌、细菌或病毒感染; (3)处于妊娠及哺乳期妇女; (4)近 1 个月内参加过其他药物临床研究者; (5)排除急性期湿疹患者;

Exclusion criteria:

(1)Patients with severe cardiovascular pulmonary liver kidney gastrointestinal hematologic endocrine or psychiatric diseases; (2)Presence of fungal bacterial or viral infections at the affected site; (3)Pregnant or breastfeeding women; (4)Participants in other drug clinical trials within the past 1 month; (5)Exclude patients with acute eczema.

研究实施时间:

Study execute time:

From 2023-12-15

To      2026-10-01

征募观察对象时间:

Recruiting time:

From 2023-12-15

To      2026-10-01

干预措施:

Interventions:

组别:

维医治疗组

样本量:

60

Group:

Uighur medicine treatment group

Sample size:

干预措施:

-

干预措施代码:

Intervention:

-

Intervention code:

组别:

维西医治疗组

样本量:

60

Group:

Uighur and Western medicine treatment group

Sample size:

干预措施:

-

干预措施代码:

Intervention:

-

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

新疆

市(区县):

乌鲁木齐

Country:

China

Province:

Xinjiang

City:

Urumqi

单位(医院):

新疆维吾尔自治区维吾尔医医院

单位级别:

三级甲

Institution/hospital:

Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital Level of the 

Level of the institution:

Third level A

测量指标:

Outcomes:

指标中文名:

湿疹的面积和严重程度(EASI)

指标类型:

主要指标

Outcome:

Extent and severity of eczema

Type:

Primary indicator

测量时间点:

-

测量方法:

-

Measure time point of outcome:

Measure method:

指标中文名:

瘙痒程度评分

指标类型:

次要指标

Outcome:

Severity of itching score

Type:

Secondary indicator

测量时间点:

-

测量方法:

-

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量表(DLQI 评分)

指标类型:

次要指标

Outcome:

"Dermatology Life Quality Index (DLQI)

Type:

Secondary indicator

测量时间点:

-

测量方法:

-

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

皮肤组织

组织:

Sample Name:

skin tissue

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

粪便

组织:

Sample Name:

Feces

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

整群随机对照

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

Cluster randomized controlled trial

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

-

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

-

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

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

Electronic data collection and management system

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

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

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