Effect of nourishing blood and moistening dryness on serum inflammatory factors and quality of life in patients with moderate and severe atopic dermatitis

注册号:

Registration number:

ITMCTR2025000198

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

养血润燥法对中重度特应性皮炎患者血清炎症因子干预及生活质量的影响

Public title:

Effect of nourishing blood and moistening dryness on serum inflammatory factors and quality of life in patients with moderate and severe atopic dermatitis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

养血润燥法对中重度特应性皮炎患者血清炎症因子干预及生活质量的影响

Scientific title:

Effect of nourishing blood and moistening dryness on serum inflammatory factors and quality of life in patients with moderate and severe atopic dermatitis

研究课题的正式科学名称简写:

养血润燥法对中重度皮炎患者缓解期的预防治疗

Scientific title acronym:

Prevention and treatment of moderate and severe dermatitis patients in remission by nourishing blood and moistening dryness

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:

孟园园

研究负责人:

杨延龙

Applicant:

Meng Yuanyuan

Study leader:

Yang Yanlong

申请注册联系人电话:

Applicant telephone:

13122399507

研究负责人电话:

Study leader's telephone:

13524420985

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:

yanlongyangzy@163.com

研究负责人电子邮件:

Study leader's E-mail:

yanlongyangzy@163.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:

上海市长海路168号

研究负责人通讯地址:

上海市长海路168号

Applicant address:

No.168 Changhai Road Shanghai

Study leader's address:

No.168 Changhai Road Shanghai

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:

海军军医大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Naval Military Medical University

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:

CHEC2024-361

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海长海医院医学伦理委员会

Name of the ethic committee:

Shanghai Changhai Hospital Medical Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/28 0:00:00

伦理委员会联系人:

杜奕奇

Contact Name of the ethic committee:

Du Yiqi

伦理委员会联系地址:

上海市长海路168号

Contact Address of the ethic committee:

No.168 Changhai Road Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

86-21-31162338

伦理委员会联系人邮箱:

Contact email of the ethic committee:

changhaiec@126.com

研究实施负责(组长)单位:

海军军医大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Naval Military Medical University

研究实施负责(组长)单位地址:

上海市长海路168号

Primary sponsor's address:

No.168 Changhai Road Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

杨浦区

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

海军军医大学第一附属医院

具体地址:

上海市长海路168号

Institution
hospital:

The First Affiliated Hospital of Naval Military Medical University

Address:

No.168 Changhai Road Shanghai

经费或物资来源:

上海市科技委员会

Source(s) of funding:

Shanghai Science and Technology Commission

研究疾病:

特应性皮炎

研究疾病代码:

Target disease:

Atopic Dermatitis

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:

其它

Others

研究目的:

本项目通过随机、双盲、对照临床试验,评估养血润燥法对中重度特应性皮炎患者血清炎症因子干预及生活质量的影响,并评估夏氏皮肤科养血润燥法防治中重度特应性皮炎缓解期复发的临床疗效和安全性,以获得高级别循证医学证据。

Objectives of Study:

Through randomized, double-blind, controlled clinical trials, this project evaluates the influence of nourishing blood and moistening dryness on the intervention of serum inflammatory factors and the quality of life of patients with moderate and severe atopic dermatitis, and evaluates the clinical efficacy and safety of nourishing blood and moistening dryness in Xia's dermatology to prevent and treat the recurrence of moderate and severe atopic dermatitis in remission, so as to obtain high-level evidence-based medical evidence.

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) 符合中西医诊断标准,明确诊断为特应性皮炎患者; (2) 年龄≥2岁且≤75岁;性别不限; (3) 患者既往曾有中重度特应性皮炎病史; (4) 患者处于AD缓解期,连续2周皮损IGA评分 ≤ 1分; (5) 全部患者或监护人均签署知情同意书,其中,2-8岁(<8)患者由监护人签署知情同意书;8-18岁(<18)患者由患者与监护人共同签署知情同意书;18-75岁患者由患者签署知情同意书。

Inclusion criteria

(1) in line with the diagnostic criteria of traditional Chinese and western medicine, a clear diagnosis of atopic dermatitis patients; (2) Age ≥2 years and ≤75 years; Gender is not limited; (3) The patient had a history of moderate and severe atopic dermatitis; (4) The patient was in remission of AD, and the IGA score of skin lesions was ≤ 1 for 2 weeks; (5) All patients or guardians have signed informed consent forms, among which, patients aged 2-8 (< 8) have signed informed consent forms by guardians; For patients aged 8-18 (< 18), the informed consent form shall be jointly signed by the patient and the guardian; Patients aged 18-75 are informed consent signed by patients.

排除标准:

(1) 处于急性发病期,且有糜烂、渗出、继发感染的患者; (2) 对受试品及其成分过敏者; (3) 目前正在参加其他临床研究或1个月以内参加过其他临床研究的患者; (4) 在需要治疗区域有除AD以外其他皮肤病的患者; (5) 患有严重肝肾疾病、血液系统疾病、自身免疫性疾病、慢性严重感染、糖尿病或神疾病,有吸毒或酗酒行为等; (6) 患有恶性肿瘤或其他可能影响正确评估疗效的严重疾病; (7) 曾使用度普利尤单抗停药≤12周,或曾使用JAK抑制剂停药≤1周; (8) 曾系统使用激素、其他免疫抑制剂治疗或光疗的患者; (9) 研究者认为不能入选的其他原因(如依从性差、不能按期随诊)。

Exclusion criteria:

(1) Patients in acute stage with erosion, exudation and secondary infection; (2) allergic to the test article and its components; (3) Patients who are currently participating in other clinical studies or have participated in other clinical studies within one month; (4) Patients with other skin diseases except AD in the area to be treated; (5) Suffering from severe liver and kidney diseases, blood system diseases, autoimmune diseases, chronic severe infections, diabetes or mental diseases, and taking drugs or drinking alcohol; (6) Suffering from malignant tumor or other serious diseases that may affect the correct evaluation of curative effect; (7) Discontinued with duprizumab for ≤12 weeks, or stopped with JAK inhibitor for ≤1 week; (8) Patients who have systematically used hormones, other immunosuppressants or phototherapy; (9) Other reasons that the researcher thinks can't be selected (such as poor compliance and failure to follow up on schedule).

研究实施时间:

Study execute time:

From 2024-12-02

To      2027-06-01

征募观察对象时间:

Recruiting time:

From 2024-12-02

To      2027-06-01

干预措施:

Interventions:

组别:

试验组

样本量:

25

Group:

Observation group

Sample size:

干预措施:

三亚油酸甘油酯乳膏

干预措施代码:

Intervention:

Glyceryl trillinoate cream

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

基础润肤剂

干预措施代码:

Intervention:

Basic emollient

Intervention code:

样本总量 Total sample size : 50

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

单位级别:

三级甲等

Institution/hospital:

8、 Shuguang hospital affiliated to Shanghai university of traditional Chinese medicine

Level of the institution:

Third-grade A

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

海军军医大学第一附属医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Naval Military Medical University

Level of the institution:

Third-grade A

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院

单位级别:

三级甲等

Institution/hospital:

Huashan hospital affiliated to Fudan university

Level of the institution:

Third-grade A

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

单位级别:

三级甲等

Institution/hospital:

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Third-grade A

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等

Institution/hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Third-grade A

测量指标:

Outcomes:

指标中文名:

皮肤病生活质量指数

指标类型:

次要指标

Outcome:

Dermatology Life Quality Index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

研究者整体评价

指标类型:

次要指标

Outcome:

Investigator Global Assessment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉瘙痒模拟评分

指标类型:

次要指标

Outcome:

Visual Analogue Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

湿疹面积及严重程度指数

指标类型:

次要指标

Outcome:

Eczema Area and Severity Index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清总IgE

指标类型:

次要指标

Outcome:

IgE

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血免疫功能(Th1/Th2/Th17细胞因子)

指标类型:

次要指标

Outcome:

Th1/Th2/Th17

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发时间

指标类型:

主要指标

Outcome:

Recurrence time

Type:

Primary indicator

测量时间点:

给药开始至复发评定时间的天数

测量方法:

医师评估

Measure time point of outcome:

The number of days from the start of drug administration to the time of recurrence assessment

Measure method:

Physician evaluation

采集人体标本:

Collecting sample(s)
from participants:

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 2
Min age years
最大 75
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):

本研究拟采用区组随机化法,由统计人员应用临床研究计算机辅助系统产生《中心编码随机数字表》,本课题的随机化方案和具体操作由由江苏法迈生医学科技有限公司负责实施

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

This study intends to adopt block randomization method and statisticians will use the computer-aided system of clinical research to generate the Central Coding Random Number Table. The randomization scheme and specific operation of this topic will be implemented by Jiangsu Fa dextromethorphan hydrobromide dispersible tablets Medical Technology Co. Ltd.

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):

不共享原始数据

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

Do not share the original data

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:

本研究采用电子数据采集(EDC)系统,通过EDC系统的电子数据录入、数据的验证、数据的核查等功能,完成在线数据管理。

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

In this study electronic data acquisition (EDC) system is adopted and online data management is completed through the functions of electronic data entry data verification and data verification of EDC 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):

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