针刺治疗对难治性胃食管反流病患者食管动力的影响

注册号:

Registration number:

AMCTR-IOR-18000227 

注册号获得时间:

Date of releasing the registration number:

2018/11/20 10:30:49 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

针刺治疗对难治性胃食管反流病患者食管动力的影响 

Public title:

Effect of acupuncture on esophageal motility:A study using high-resolution manometry in refractory gastroesophageal reflux disease 

研究课题的正式科学名称:

针刺治疗对难治性胃食管反流病患者食管动力的影响 

Scientific title:

Effect of acupuncture on esophageal motility: A study using high-resolution manometry in refractory gastroesophageal reflux disease 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

赵雨娉 

研究负责人:

姚玮艳 

Applicant:

Zhao Yuping 

Study leader:

Yao Weiyan 

申请注册联系人电话:

Applicant telephone:

18817555413 

研究负责人电话:

Study leader's telephone:

13917519286 

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:

zyp01782@rjh.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

ywy11419@rjh.com.cn 

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:

上海市黄浦区瑞金二路197号 

研究负责人通讯地址:

上海市黄浦区瑞金二路197号 

Applicant address:

No 197, Shanghai Rui Jin 2nd Road, Shanghai, China 

Study leader's address:

No 197, Shanghai Rui Jin 2nd Road, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital 

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:

(2014)临伦审第(57)号 

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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Shanghai Jiaotong University School of medicine, Ruijin hospital ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-08-01 

研究实施负责(组长)单位:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Shanghai Jiaotong University School of Medicine Affiliated Ruijin hospital 

研究实施负责(组长)单位地址:

上海市黄浦区瑞金二路197号 

Primary sponsor's address:

No 197, Shanghai Rui Jin 2nd Road, Shanghai, 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):

上海市

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市黄浦区瑞金二路197号

Institution
hospital:

Shanghai Jiaotong University School of Medicine Affiliated Ruijin hospital

Address:

Shanghai 197 Rui Jin 2nd Road, Shanghai, China

经费或物资来源:

上海交通大学医工交叉研究基金 

Source(s) of funding:

Fund of Interdisciplinary research Between Medical and Engineering in Shanghai Jiao Tong University 

研究疾病:

难治性胃食管反流病 

Target disease:

Refractory Gastroesophageal Reflux Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

采用高分辨率食管测压检测作为客观评价标准,观察针灸治疗前后难治性胃食管反流病(rGERD)的食管压力及蠕动功能的改善情况,初步探究针刺治疗对rGERD的临床疗效。 

Objectives of Study:

To investigate the improvement of esophageal motility in patients with refractory gastroesophageal reflux disease(rGERD) after acupuncture treatment. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

a、有胃食管反流病相关症状,如:烧心、泛酸、胸骨后灼痛、平卧或睡眠时呛咳、咽喉不适等; b、6个月内经胃镜检查或24小时食管PH监测及阻抗分析明确有胃食管反流病; c、在本研究前连续服用8周或8周以上标准剂量PPI治疗失败者; d、意识清楚,能够主观表达不适症状者; 

Inclusion criteria

1) gastroesophageal reflux disease-related symptoms, such as: heartburn, pantothenic acid, burning after sternum, supine or coughing during sleep, throat discomfort, GERD Q score ≥ 8 points; 2) Gastroesophageal reflux disease was clearly confirmed by gastroscopy or 24-hour esophageal PH monitoring Confirmed acid reflux; 3) Failure of standard dose proton pump inhibitor therapy for 8 weeks or more after continuous administration; 4)conscious and able to express subjective symptoms. 

排除标准:

a、合并下列消化系统疾病之一者:消化性溃疡、胃食管或十二指肠手术史、卓-艾综合征、原发性食道动力疾患(如贲门失弛缓症、硬皮病、原发性食道痉挛)、上消化道恶性病变、药物性食管炎、鼻咽部或食管梗阻; b、长期服用其他治疗胃食管反流病药物,且在本次研究前一个月未停用者; c、严重精神疾患、或其他对治疗理解障碍不能配合按时服药和进行相关检查者; d、严重的心脏、肺、脑血管疾病及造血系统疾病,或凝血功能异常; f、目前在怀孕和哺乳期间; g、针刺部位皮损、感染等; 

Exclusion criteria:

1) Incorporating one of the following diseases of the digestive system: peptic ulcer, history of gastroesophageal or duodenal surgery, zollinger-ellison syndrome, primary esophageal motility disorders (eg, achalasia, scleroderma) , primary esophageal fistula), upper gastrointestinal malignancy, drug esophagitis, nasopharyngeal or esophageal obstruction; 2) long-term use of other drugs for the treatment of gastroesophageal reflux disease, and did not disable one month before the study 3) severe mental illness, or other understanding of the treatment of disorders can not meet the patient on time and related examination; 4) severe heart, lung, cerebrovascular diseases and hematopoietic diseases, or coagulation dysfunction; 5) Currently during pregnancy and lactation; 6) skin lesions, skin infections and other acupuncture taboos; 

研究实施时间:

Study execute time:

From2014-08-01To 2018-12-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

35

Group:

Acupuncture Group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

对照组

样本量:

35

Group:

Control Group

Sample size:

干预措施:

平卧

干预措施代码:

Intervention:

dorsal position

Intervention code:

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):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Jiaotong University School of Medicine Affiliated Ruijin hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

正常收缩

指标类型:

主要指标 

Outcome:

normal contraction

Type:

Primary indicator 

指标中文名:

完整收缩

指标类型:

主要指标 

Outcome:

intact contraction

Type:

Primary indicator 

指标中文名:

远端收缩积分

指标类型:

次要指标 

Outcome:

distal contractile integral

Type:

Secondary indicator 

指标中文名:

LES松弛压

指标类型:

次要指标 

Outcome:

integrated relaxation pressure

Type:

Secondary indicator 

指标中文名:

远端收缩延迟

指标类型:

次要指标 

Outcome:

distal latency

Type:

Secondary indicator 

指标中文名:

大型蠕动缺失

指标类型:

次要指标 

Outcome:

large break in the 20mmhg isobaric contour

Type:

Secondary indicator 

指标中文名:

LES 静息压

指标类型:

次要指标 

Outcome:

mean basal LES pressure

Type:

Secondary indicator 

指标中文名:

LES长度

指标类型:

次要指标 

Outcome:

the length of LES

Type:

Secondary indicator 

指标中文名:

UES静息压

指标类型:

次要指标 

Outcome:

mean basal UES pressure

Type:

Secondary indicator 

指标中文名:

UES松弛压

指标类型:

次要指标 

Outcome:

UES relaxation pressure

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

按照1:1的比例将受试者随机分配到针刺组、对照组。采用spss24.0统计分析软件产生研究所需的随机方案生成随机号,由负责随机人员将其分装于70个不透光的信封中,病例顺序号标在信封的外面,严格按照符合入组病例进入临床试验的顺序号与信封外面顺序号一致的原则。

性别:

男女均可

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

Subjects were randomly assigned to the acupuncture group and the control group according to a ratio of 1:1. The spss22.0 statistical analysis software was used to generate the random number needed for the study to generate random numbers, which were distributed by the responsible random personnel.

Gender:

Both

盲法:

由于针灸临床的特殊性,不能采用严格标准的盲法进行评价,故由不知分组情况的第三者进行疗效评价;实行疗效评价者、操作者及统计人员三分离。对受试者、疗效评价者及统计分析人员施盲。

Blinding:

Due to the special nature of acupuncture, it can not be evaluated by the strict standard blind method. Therefore, the third party who does not know the grouping situation evaluates the efficacy; the efficacy evaluation, the operator and the statistician are separated. Blindness of subjects, efficacy evaluators, and statistical analysts.

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后公开,内容包括原始记录数据和研究计划书

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

Published after the trial is completed, including original record data and research plan

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

病例记录表

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Case Record Form

创建人:

Creater Name:

 2018-11-02
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