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A multicenter randomized controlled trial of functional dyspepsia treated with acupuncture related to meridians and viscera
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注册号:

Registration number:

ChiCTR2300068001 

最近更新日期:

Date of Last Refreshed on:

2023-02-02 

注册时间:

Date of Registration:

2023-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于经穴脏腑相关针刺治疗功能性消化不良的多中心临床随机对照试验 

Public title:

A multicenter randomized controlled trial of functional dyspepsia treated with acupuncture related to meridians and viscera 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于经穴脏腑相关针刺治疗功能性消化不良的多中心临床随机对照试验 

Scientific title:

A multicenter randomized controlled trial of functional dyspepsia treated with acupuncture related to meridians and viscera 

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:

ChiMCTR2300006973 

申请注册联系人:

刘密 

研究负责人:

刘未艾/刘密 

Applicant:

Mi Liu 

Study leader:

Weiai Liu/Mi Liu 

申请注册联系人电话:

Applicant telephone:

15116387811 

研究负责人电话:

Study leader's telephone:

13787016026/15116387811 

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:

newmean9722@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

55999630@qq.com 

申请单位网址(自愿提供):

Applicant 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:

湖南省长沙市岳麓区含浦科教产业园学士路300号  

研究负责人通讯地址:

湖南省长沙市蔡锷北路233号/湖南省长沙市岳麓区含浦科教产业园学士路300号 

Applicant address:

300 Xuesheng Road, Hanpu Science and Education Park, Yuelu District, Changsha, Hunan province, China 

Study leader's address:

The Second Affiliated Hospital of Hunan University of Chinese Medicine/No.300 Xuesheng Road, Hanpu Science and Education Park, Yuelu District, Changsha, Hunan province, China 

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:

湖南中医药大学 

Applicant's institution:

Hunan University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2022-KY-012 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

湖南中医药大学第二附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-08-02 

伦理委员会联系人:

杨声辉 

Contact Name of the ethic committee:

Shenghui Yang 

伦理委员会联系地址:

湖南省长沙市开福区蔡锷北路233号 

Contact Address of the ethic committee:

233 Caie Bei Lu, Kaifu District, Changsha City, Hunan Province, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 731 84917719 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

湖南中医药大学第二附属医院/湖南中医药大学 

Primary sponsor:

The Second Affiliated Hospital of Hunan University of Chinese Medicine/Hunan University of Chinese Medicine 

研究实施负责(组长)单位地址:

湖南省长沙市蔡锷北路233号/湖南省长沙市岳麓区含浦科教产业园学士路300号 

Primary sponsor's address:

The Second Affiliated Hospital of Hunan University of Chinese Medicine/No.300 Xuesheng Road, Hanpu Science and Education Park, Yuelu District, Changsha, Hunan province, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hunan

City:

Changsha

单位(医院):

湖南中医药大学第二附属医院

具体地址:

湖南省长沙市蔡锷北路233号

Institution
hospital:

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Address:

233 CAI 'e North Road, Changsha City, Hunan Province, China

国家:

中国

省(直辖市):

湖南省

市(区县):

长沙

Country:

China

Province:

Hunan Province

City:

Changsha

单位(医院):

湖南中医药大学

具体地址:

湖南省长沙市岳麓区含浦科教园学士路300号

Institution
hospital:

Hunan University of Chinese Medicine

Address:

300 Xuesheng Road, Hanpu Science and Education Park, Yuelu District, Changsha, Hunan province, China

经费或物资来源:

国家中医药管理局“基于重点研究室研究领域的中医临床疗效提升项目”;湖南省中医药科研重点项目(C2022027) 

Source(s) of funding:

State Administration of Traditional Chinese Medicine ; Hunan Provincial Key Project of Traditional Chinese Medicine Research (C2022027) 

研究疾病:

功能性消化不良 

Target disease:

Functional Dyspepsia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

评价三段针刺法治疗功能性消化不良的有效性及安全性。 

Objectives of Study:

To evaluate the effectiveness and safety of the three-stage acupuncture method in the treatment of functional dyspepsia. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合功能性消化不良西医诊断标准; (2)年龄为18~70岁; (3)经胃镜、B超等检查未见相关的器质性病变; (4)自愿签署知情同意书; (5)依从性好的患者。 

Inclusion criteria

(1) Meet the western diagnostic criteria for functional dyspepsia; (2) 18-70 years old; (3) No organic lesions were found by gastroscopy and B-ultrasound; (4) Voluntarily sign informed consent; (5) Patients with good compliance. 

排除标准:

(1)近2周服用过或正在服用影响胃肠动力或胃酸分泌的药物或其他功能性消化不良相关干预措施; (2)近14天接受过针灸治疗者; (3)合并其他胃肠性疾病; (4)妊娠、哺乳期妇女或备孕者; (5)有严重心、肺、肝、脾、肾及血液病变者,有严重的内分泌代谢性疾病、心脑血管疾病、自身免疫性疾病以及恶性肿瘤等病史者; (6)有严重精神、心理障碍者(SAS≤50、SDS≤50) 

Exclusion criteria:

(1) Drugs that affect gastrointestinal motility or gastric acid secretion or other functional dyspepsia related interventions have been taken or are being taken in the last 2 weeks; (2) Those who have received acupuncture treatment in the last 14 days; (3) Complicated with other gastrointestinal diseases; (4) Pregnant or breast-feeding women or pregnant women; (5) Patients with serious heart, lung, liver, spleen, kidney and blood diseases, serious history of endocrine and metabolic diseases, cardiovascular and cerebrovascular diseases, autoimmune diseases and malignant tumors; (6) Persons with severe mental and psychological disorders (SAS ≤ 50, SDS ≤ 50) 

研究实施时间:

Study execute time:

From2023-03-01To 2024-06-30 

征募观察对象时间:

Recruiting time:

From2023-03-01To 2024-06-30 

干预措施:

Interventions:

组别:

针刺组

样本量:

89

Group:

Acupuncture Group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture therapy

Intervention code:

组别:

药物组

样本量:

89

Group:

Drug group

Sample size:

干预措施:

口服兰索拉唑

干预措施代码:

Intervention:

Oral lansoprazole

Intervention code:

组别:

等待治疗组

样本量:

89

Group:

wait-and-see group

Sample size:

干预措施:

无干预,研究结束后,患者可选择接受与其他组别相同治疗周期的针刺或药物治疗。

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan Province 

City:

Changsha 

单位(医院):

湖南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Hunan University of Chinese Medicine  

Level of the institution:

tertiary hospital 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙 

Country:

China 

Province:

Hunan Province 

City:

Changsha 

单位(医院):

湖南中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Hunan University of Chinese Medicine  

Level of the institution:

tertiary hospital 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙 

Country:

China 

Province:

Hunan Province 

City:

Changsha 

单位(医院):

长沙市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Changsha Traditional Chinese Medicine Hospital  

Level of the institution:

3a grade 

测量指标:

Outcomes:

指标中文名:

症状消除率

指标类型:

主要指标 

Outcome:

Symptom resolution rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

上消化道症状严重程度量表评分

指标类型:

次要指标 

Outcome:

Upper Gastrointestinal Symptom Severity Scale (PAGI-SYM) 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:

尼平消化不良指数简表

指标类型:

次要指标 

Outcome:

Nipin Dyspepsia Index Short Form (SF-NDI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

利兹消化不良调查问卷

指标类型:

次要指标 

Outcome:

Leeds Dyspepsia Questionnaire (LDQ)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性消化不良生存质量量表

指标类型:

次要指标 

Outcome:

Functional Dyspepsia Quality of Life Scale (FDDQL)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36量表

指标类型:

次要指标 

Outcome:

SF - 36 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:

汉密尔顿焦虑量表

指标类型:

次要指标 

Outcome:

Hamilton Anxiety Inventory (HAMA)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Depression Scale (HAMD)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院用抑郁焦虑量表

指标类型:

次要指标 

Outcome:

Hospital Depression and Anxiety Scale (HADS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃动素

指标类型:

次要指标 

Outcome:

Motilin (MTL)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

5-羟色胺

指标类型:

次要指标 

Outcome:

5-hydroxytryptamine (5-HT)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生长抑素

指标类型:

次要指标 

Outcome:

Somatostatin (SS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

P物质

指标类型:

次要指标 

Outcome:

Substance P (SP)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促生长素

指标类型:

次要指标 

Outcome:

Ghrelin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

4周后尼平消化不良指数简表

指标类型:

主要指标 

Outcome:

Nipin Dyspepsia Index Short Form (SF-NDI) after 4 weeks

Type:

Primary indicator 

测量时间点:

4周后

测量方法:

Measure time point of outcome:

After 4 weeks

Measure method:

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用分层区组随机化方法,将中心作为分层因素,设定区组大小为4和6,按照1:1:1的比例将受试者随机分配到针刺组、药物组及等待治疗组。采用SAS9.3统计分析软件的“Procplan”程序产生研究所需的随机方案。

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

A stratified group randomization method was used, with center as the stratification factor, and group sizes of 4 and 6 were set, and subjects were randomly assigned to the acupuncture group, the drug group, and the waiting group in a 1:1:1 ratio. The "Procplan" program of SAS 9.3 statistical analysis

盲法:

实行疗效评价者、针刺操作者及统计人员三分离。本研究采用开放标签,不设盲。

Blinding:

A triple separation of efficacy evaluator, acupuncture operator and statistician was implemented. The study was open-label and unblinded.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

百度网盘

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

BAIDU CLOUD

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2023-02-02
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