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不同频率提插针刺手法对功能性消化不良(FD)上腹痛综合征(EPS)疗效影响的比较研究
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注册号:

Registration number:

ChiCTR-IOR-16008189 

最近更新日期:

Date of Last Refreshed on:

2016-03-30 

注册时间:

Date of Registration:

2016-03-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同频率提插针刺手法对功能性消化不良(FD)上腹痛综合征(EPS)疗效影响的比较研究  

Public title:

The effects of lifting-inserting needle manipulations with different frequencies on the epigastric pain syndrome (EPS) in function dyspepsia(FD) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同频率提插针刺手法对功能性消化不良(FD)上腹痛综合征(EPS)疗效影响的比较研究  

Scientific title:

The effects of lifting-inserting needle manipulations with different frequencies on the epigastric pain syndrome (EPS) in function dyspepsia(FD) patients 

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:

洪寿海 

研究负责人:

洪寿海 

Applicant:

Shouhai Hong 

Study leader:

Shouhai Hong 

申请注册联系人电话:

Applicant telephone:

+86 18072784265 

研究负责人电话:

Study leader's telephone:

+86 18072784265 

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:

hongshouhai@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hongshouhai@163.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:

浙江省杭州市邮电路54号 

研究负责人通讯地址:

浙江省杭州市邮电路54号 

Applicant address:

54 Youdian Road, Hangzhou. Zhejiang, China 

Study leader's address:

54 Youdian Road, Hangzhou. Zhejiang, 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:

浙江省中医院 

Applicant's institution:

Zhejiang Provincial Hospital of TCM 

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:

2016-K-057-01 

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:

浙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic committee of the First Affiliated Hospital of Zhejiang Chinese Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-09-30 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

浙江省中医院 

Primary sponsor:

Zhejiang Provincial Hospital of TCM 

研究实施负责(组长)单位地址:

浙江省杭州市邮电路54号 

Primary sponsor's address:

54 Youdian Road, Hangzhou. Zhejiang, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江省中医院

具体地址:

浙江省杭州市邮电路54号

Institution
hospital:

Zhejiang Provincial Hospital of TCM

Address:

54 Youdian Road, Hangzhou. Zhejiang, China

经费或物资来源:

浙江省中医药科研基金计划资助 

Source(s) of funding:

TCM scientific research foundation of Zhejiang provincial 

研究疾病:

功能性消化不良 

Target disease:

Function 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:

其它 

Study phase:

N/A 

研究目的:

阐明不同频率提插针刺手法治疗FD上腹痛综合征的疗效差异及其部分生物学机制 

Objectives of Study:

To clarify the different therapeutic effects and possible biological mechanisms of lifting-inserting needle manipulations with different frequencies on the epigastric pain syndrome (EPS) in function dyspepsia(FD) patients 

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FD诊断标准,同时符合EPS分型诊断标准的患者 (诊断标准参照2006年罗马 Ⅲ 学术委员会制定的FD及其亚型EPS的诊断标准); ②年龄在18~60 岁之间者(包括18和65); ③在本研究过程中没有接受其他治疗; ④患者本人签署知情同意书,自愿参加本项研究者 

Inclusion criteria

1. Individuals who meet the Rome III FD criteria, and within a subgroup of epigastric pain syndrome (EPS); 2. Individuals between the ages of 18 and 60 years; 3. Individuals who receive no other treatments during the study; 4. Individuals who voluntarily agree with a study protocol and sign a written informed consent. 

排除标准:

① 不同意签署之情同意书者; ② 合并心、肺、肝、肾、消化及造血系统等严重器质性病变以及患有精神障碍者; ③ 合并可能影响针刺治疗的其他疾病,如凝血障碍、白细胞减少、起搏器、癫痫,或抗凝治疗; ④ 孕妇及哺乳期妇女; ⑤ 不能顺利完成试验者,如瘫痪,癌症,痴呆,药物成瘾,时间限制,外科手术。  

Exclusion criteria:

1. Individuals unwilling to sign the informed consent; 2. Individuals who have serious structural disease (disease of heart, lung, liver, kidney, digestive system or hematopoietic system ) or mental illness; 3. Individuals with other diseases that could interfere with acupuncture treatment, e.g., clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy; 4. Individuals who are pregnant or breastfeeding; 5. Individuals who have difficulties in attending the trial (e.g., paralysis, cancer, dementia, drug addiction, time constraint, surgical operation). 

研究实施时间:

Study execute time:

From2016-07-01To 2017-04-30 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2017-07-31 

干预措施:

Interventions:

组别:

针刺手法1组

样本量:

22

Group:

Needling manipulation 1

Sample size:

干预措施:

60次/分钟提插针刺手法

干预措施代码:

Intervention:

Lifting-inserting needling manipulations with 1 times/s

Intervention code:

组别:

针刺手法2组

样本量:

22

Group:

Needling manipulation 2

Sample size:

干预措施:

120次/分钟提插针刺手法

干预措施代码:

Intervention:

Lifting-inserting needling manipulations with 2 times/s

Intervention code:

组别:

针刺手法3组

样本量:

22

Group:

Needling manipulation 3

Sample size:

干预措施:

180次/分钟提插针刺手法

干预措施代码:

Intervention:

Lifting-inserting needling manipulations with 3 times/s

Intervention code:

组别:

对照组

样本量:

22

Group:

Control group

Sample size:

干预措施:

奥美拉唑

干预措施代码:

Intervention:

Omeprazole

Intervention code:

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):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

尼平消化不良指数评分

指标类型:

主要指标 

Outcome:

Nepean Dyspepsia Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

健康相关生活质量评分

指标类型:

主要指标 

Outcome:

36-itemShort-form Heath Survey

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表评分

指标类型:

主要指标 

Outcome:

Self-rating depression scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表评分

指标类型:

主要指标 

Outcome:

Self-Rating Anxiety Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清胃动素

指标类型:

次要指标 

Outcome:

Motilin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃泌素

指标类型:

次要指标 

Outcome:

Gastrin

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:

不良事件发生率

指标类型:

副作用指标 

Outcome:

Incidence of adverse events

Type:

Adverse events 

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:

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 years
最大 Max age 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):

由独立的第三方——杭州泰格医药科技有限公司统计人员采用SAS 9.2 软件中的PROC PLAN产生随机数字表。

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

Random numbers will be generated using the PROC PLAN of SAS 9.2 (SAS Institute Inc., Cary, NC,USA) by an independent statistician, who come from the Tigermed Pharmaceutical Science And Technology Co., L.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

原始数据将在2018年2月之前公开,公众可通过临床试验公共管理平台查询原始数据

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

Original date will be shared before February 2018; The public could access the date by the Clinical Trial Management Public Platform

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:

采用临床试验公共管理平台

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

Use the Clinical Trial Management Public Platform

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:

 2016-03-30
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