艾盐包药熨疗法缓解儿童静脉输注阿奇霉素消化道副作用的临床研究

注册号:

Registration number:

ITMCTR2024000452

最近更新日期:

Date of Last Refreshed on:

2024-09-17

注册时间:

Date of Registration:

2024-09-17

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

艾盐包药熨疗法缓解儿童静脉输注阿奇霉素消化道副作用的临床研究

Public title:

A clinical study on the use of Ai Yan Bao Yao Tie therapy to alleviate gastrointestinal side effects of intravenous infusion of azithromycin in children

注册题目简写:

English Acronym:

研究课题的正式科学名称:

儿童静脉输注阿奇霉素消化道副作用的临床研究

Scientific title:

travenous infusion of azithromycin in children

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:

洪微娜

研究负责人:

洪微娜

Applicant:

Weina Hong

Study leader:

Weina Hong

申请注册联系人电话:

Applicant telephone:

13634087002

研究负责人电话:

Study leader's telephone:

13634087002

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:

1497380479@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1497380479@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:

浙江省台州市椒江区葭沚街道智谷路199号

研究负责人通讯地址:

浙江省台州市椒江区葭沚街道智谷路199号

Applicant address:

No. 199 Zhigu Road, Jiaqian Street, Jiaojiang District, Taizhou City, Zhejiang Province

Study leader's address:

No. 199 Zhigu Road, Jiaqian Street, Jiaojiang District, Taizhou City, Zhejiang 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:

台州市妇女儿童医院

Applicant's institution:

Taizhou Women and Children's 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:

2024-KY001-01

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:

台州市妇女儿童医院伦理委员会

Name of the ethic committee:

Ethics Committee of Taizhou Women and Children's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/19 0:00:00

伦理委员会联系人:

方林峰

Contact Name of the ethic committee:

Lifeng Fang

伦理委员会联系地址:

浙江省台州市椒江区葭沚街道智谷路199号

Contact Address of the ethic committee:

No. 199 Zhigu Road, Jiaqian Street, Jiaojiang District, Taizhou City, Zhejiang Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 187 6839 6276

伦理委员会联系人邮箱:

Contact email of the ethic committee:

1322554550@qq.com

研究实施负责(组长)单位:

台州市妇女儿童医院

Primary sponsor:

Taizhou Women and Children's Hospital

研究实施负责(组长)单位地址:

浙江省台州市椒江区葭沚街道智谷路199号

Primary sponsor's address:

No. 199 Zhigu Road, Jiaqian Street, Jiaojiang District, Taizhou City, Zhejiang 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

台州市妇女儿童医院

具体地址:

浙江省台州市椒江区葭沚街道智谷路199号

Institution
hospital:

Taizhou Women and Children's

Address:

No. 199 Zhigu Road, Jiaqian Street, Jiaojiang District, Taizhou City, Zhejiang Province

经费或物资来源:

台州市妇女儿童医院

Source(s) of funding:

Taizhou Women and Children's Hospital

研究疾病:

静脉用阿奇霉素副作用

研究疾病代码:

Target disease:

Side effects of intravenous azithromycin

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:

研究艾盐包药熨疗法防治阿奇霉素消化道副作用的临床疗效

Objectives of Study:

Study on the clinical efficacy of Ai Yan Bao Yao Tie therapy in preventing and treating gastrointestinal side effects of azithromycin

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年龄在 2-9 岁之间,能够准确表达自己情绪的儿童;②确诊为肺炎支原体肺炎并正在接受阿奇霉素静脉注射治疗的儿童;③家长知情同意并能够忠实遵守治疗方案。

Inclusion criteria

① Children between the ages of 2 and 9 who are able to accurately express their emotions; ② Children diagnosed with Mycoplasma pneumoniae pneumonia and receiving intravenous injection of azithromycin treatment; ③ Parents have informed consent and are able to faithfully follow the treatment plan.

排除标准:

排除标准:①对阿奇霉素过敏者;②使用激素、非处方类消炎药或其他胃肠道刺激药物的患儿;③皮肤受损或肚脐过敏的患儿;④已有胃肠道不适症状的患儿。

Exclusion criteria:

Exclusion criteria: ① Individuals who are allergic to azithromycin; ② Children who use hormones, over-the-counter anti-inflammatory drugs, or other gastrointestinal stimulants; ③ Children with skin damage or navel allergy; ④ Children with gastrointestinal discomfort symptoms.

研究实施时间:

Study execute time:

From 2024-06-20

To      2024-11-30

征募观察对象时间:

Recruiting time:

From 2024-06-20

To      2024-11-30

干预措施:

Interventions:

组别:

对照组

样本量:

66

Group:

control group

Sample size:

干预措施:

常规护理操作

干预措施代码:

Intervention:

Routine nursing procedures

Intervention code:

组别:

实验组

样本量:

66

Group:

experimental group

Sample size:

干预措施:

使用艾盐包热熨

干预措施代码:

Intervention:

The treatment method for the treatment group is to use Ai salt pack hot ironing.

Intervention code:

样本总量 Total sample size : 132

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

台州市妇女儿童医院

单位级别:

三甲

Institution/hospital:

Taizhou Women and Children's Hospital

Level of the institution:

official tertiary hospital

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

台州市妇女儿童医院

单位级别:

三甲

Institution/hospital:

Taizhou Women and Children's Hospital

Level of the institution:

official tertiary hospital

测量指标:

Outcomes:

指标中文名:

腹痛、腹泻、恶心呕吐、食欲不振

指标类型:

主要指标

Outcome:

Abdominal pain, diarrhea, nausea and vomiting, loss of appetite

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:

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 9
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):

采用数字表法随机

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

Randomly using the number table method

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):

Resman

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

Resman

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:

基于互联网的EDC

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

a CRF and an electronic data capture

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统