壮医活体水蛭疗法治疗湿疹的护理技术规范化及临床评价研究

注册号:

Registration number:

ITMCTR2024000015

最近更新日期:

Date of Last Refreshed on:

2024-01-30

注册时间:

Date of Registration:

2024-01-30

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

壮医活体水蛭疗法治疗湿疹的护理技术规范化及临床评价研究

Public title:

Standardized nursing techniques and clinical evaluation of Zhuang Yi's live leech therapy for treating eczema

注册题目简写:

English Acronym:

研究课题的正式科学名称:

壮医活体水蛭疗法治疗湿疹的护理技术规范化及临床评价研究

Scientific title:

Standardized nursing techniques and clinical evaluation of Zhuang Yi's live leech therapy for treating eczema

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:

黄美芳

研究负责人:

龚珊鸿

Applicant:

Meifang Huang

Study leader:

Shanhong Gong

申请注册联系人电话:

Applicant telephone:

13557417718

研究负责人电话:

Study leader's telephone:

13607875337

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:

1491623304@qq.com

研究负责人电子邮件:

Study leader's E-mail:

126537081@qq.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:

广西南宁市五象新区秋月路8号

研究负责人通讯地址:

广西南宁市五象新区秋月路8号

Applicant address:

No.8 Qiuyue Road, Wuxiang New District, Nanning City, Guangxi Province

Study leader's address:

No.8 Qiuyue Road, Wuxiang New District, Nanning City, Guangxi Province

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:

广西国际壮医医院

Applicant's institution:

Guangxi International Zhuang Medicine Hospital

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:

2023-090-02

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:

广西国际壮医医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Guangxi International Zhuang Medicine Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023/9/12 0:00:00

伦理委员会联系人:

覃靖茜

Contact Name of the ethic committee:

Jingqian Qin

伦理委员会联系地址:

广西国际壮医医院行政楼1楼医学伦理办公室102

Contact Address of the ethic committee:

Medical Ethics Office 102, 1st Floor, Administrative Building, Guangxi International Zhuang Medicine Hospital

伦理委员会联系人电话:

Contact phone of the ethic committee:

0771-3376671

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gzyxllb3376671@163.com

研究实施负责(组长)单位:

广西国际壮医医院

Primary sponsor:

Guangxi International Zhuang Medicine Hospital

研究实施负责(组长)单位地址:

广西南宁市五象新区秋月路8号

Primary sponsor's address:

No.8 Qiuyue Road, Wuxiang New District, Nanning City, Guangxi Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

单位(医院):

广西国际壮医医院

具体地址:

广西南宁市五象新区秋月路8号

Institution
hospital:

Guangxi International Zhuang Medicine Hospital

Address:

No.8 Qiuyue Road, Wuxiang New District, Nanning City, Guangxi Province

经费或物资来源:

广西国际壮医医院

Source(s) of funding:

Guangxi International Zhuang Medicine Hospital

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:

其它

Others

研究目的:

1.主要研究目的:提高患者的满意度,改善湿疹患者的皮损、瘙痒等症状、提高生活质量,为临床护理提供依据。 2.次要研究目的:同质化壮医活体水蛭治疗的护理技术,提高护理安全质量。

Objectives of Study:

1.The main research objective is to improve patient satisfaction, improve symptoms such as skin lesions and itching in patients with eczema, improve quality of life, and provide a basis for clinical nursing. 2.Secondary research objective: To homogenize the nursing techniques for live leech treatment in Zhuang medicine and improve the quality of nursing safety.

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.同时符合西医诊断标准、壮医诊断标准; 2.年龄在18~70 周岁之间,性别不限; 3.自愿参加研究并签署知情同意书。

Inclusion criteria

1. Simultaneously meet the diagnostic standards of Western medicine and Zhuang medicine; 2. Between the ages of 18 and 70, regardless of gender; 3. Voluntarily participate in the study and sign an informed consent form.

排除标准:

1.孕妇及有妊娠意向的妇女; 2.患有心、脑、肝、肾、肺病变或血液病、艾滋病、肿瘤的患者; 3.有免疫缺陷或者免疫系统疾病的患者; 4.患有其他皮肤病的患者; 5.1个月内局部或系统应用皮质类固醇激素或其他治疗药物的患者; 6.凝血功能异常者。

Exclusion criteria:

1. Pregnant women and women who intend to conceive; 2. Patients with heart, brain, liver, kidney, lung disease or blood disease, AIDS, tumor; 3. Patients with immunodeficiency or immune system diseases; 4. Patients with other skin diseases; 5.Patients who have received local or systemic application of corticosteroids or other therapeutic drugs within 1 months; 6. Individuals with abnormal coagulation function.

研究实施时间:

Study execute time:

From 2023-09-12

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2024-01-01

To      2024-12-31

干预措施:

Interventions:

组别:

观察组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

壮医常规护理+壮医药线点灸+水蛭疗法

干预措施代码:

Intervention:

Routine care of Zhuang medicine+Zhuang Medicine Medicated Thread Moxibustion+Leech Therapy

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

壮医常规护理+壮医药线点灸

干预措施代码:

Intervention:

Routine care of Zhuang medicine+Zhuang Medicine Medicated Thread Moxibustion

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

单位(医院):

广西国际壮医医院

单位级别:

区直单位

Institution/hospital:

Guangxi International Zhuang Medicine Hospital

Level of the institution:

District level units

测量指标:

Outcomes:

指标中文名:

湿疹面积及严重度指数

指标类型:

主要指标

Outcome:

eczema area and severity index,EASI

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效评价

指标类型:

次要指标

Outcome:

Efficacy evaluation

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量指数量表

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:

指标中文名:

瘙痒评价

指标类型:

主要指标

Outcome:

Itching evaluation

Type:

Primary 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:

/

组织:

Sample Name:

/

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 70
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):

研究者采用随机数字表法产生随机序列

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

Researchers generate the random number sequence by the random number table

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

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

not shared

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:

数据采集:病例报告表 数据管理:excel

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

Data collection: Case report form Data Management: Excel

数据管理委员会:

Data Managemen Committee:

No

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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