硫化氢信号通路在针灸治疗功能性消化不良中的作用

注册号:

Registration number:

AMCTR-IPO-18000237 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 10:34:57 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

硫化氢信号通路在针灸治疗功能性消化不良中的作用 

Public title:

The role of hydrogen sulfide signaling pathway in acupuncture treatment of functional dyspepsia 

研究课题的正式科学名称:

硫化氢信号通路在针灸治疗功能性消化不良中的作用 

Scientific title:

The role of hydrogen sulfide signaling pathway in acupuncture treatment of functional dyspepsia 

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:

肖艾琳 

研究负责人:

肖艾琳 

Applicant:

Ailin Xiao 

Study leader:

Ailin Xiao 

申请注册联系人电话:

Applicant telephone:

13797293552 

研究负责人电话:

Study leader's telephone:

13797293552 

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:

71725947@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

71725947@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:

湖北省荆州市学苑路87号湖北中医药高等专科学校 

研究负责人通讯地址:

湖北省荆州市学苑路87号湖北中医药高等专科学校 

Applicant address:

No.87, Xueyuan Road, Jingzhou City,Hubei Province,China 

Study leader's address:

No.87, Xueyuan Road, Jingzhou City, Hubei 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:

湖北中医药高等专科学校 

Applicant's institution:

Hubei College of Traditional 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:

KYLL-2018(KJ)P-0067 

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:

山东大学第二医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the Second Hospital of ShanDong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-29 

研究实施负责(组长)单位:

湖北中医药高等专科学校 

Primary sponsor:

Hubei College of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

湖北省荆州市学苑路87号 

Primary sponsor's address:

No.87, Xueyuan Road,Jingzhou City,Hubei 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):

湖北

市(区县):

荆州

Country:

China

Province:

Hubei

City:

Jingzhou

单位(医院):

湖北中医药高等专科学校

具体地址:

湖北省荆州市学苑路87号

Institution
hospital:

Hubei College of Traditional Chinese Medicine

Address:

87xueyuan Road,jingzhou City,Hubei Province,China

经费或物资来源:

湖北省卫计委2016-2017年度中医药中西医结合科研项目 

Source(s) of funding:

2016-2017 Integrated Chinese and Western Medicine Research Project of Hubei Provincial Health and Family Planning Committee 

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 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

通过本研究探索针刺特定穴位治疗功能性消化不良的机制中是否包含:1.通过调节血清外泌体中的miRNA,进而调节其靶基因而发挥作用;2.调节体内调节H2S信号通路。并希望以此为基础进行更深入的机制研究。 

Objectives of Study:

To explore whether the mechanism of acupuncture at specific acupoints for functional dyspepsia includes: 1. regulating the target genes by regulating the microRNAs in serum exosomes; 2. regulating the H2S signaling pathway in vivo. It is hoped that more in-depth mechanism research will be carried out on this basis. 

研究设计:

其他 

Study design:

Other 

纳入标准:

FD试验组纳入标准 1.18-65岁的男性和女性; 2.符合罗马Ⅳ功能性消化不良诊断标准; 3.对本项研究知情了解,自愿参与并签署知情同意书者。 正常对照组纳入标准 1.18-65岁的男性和女性; 2.体检排除功能性胃肠疾病及其他器质性疾病; 3.对本项研究知情了解,自愿参与并签署知情同意书者。 

Inclusion criteria

FD pilot group inclusion criteria 1.18-65 years old male and female; 2.It conforms to the diagnostic criteria of Rome IV functional dyspepsia. 3.Those who know about the study, volunteer to participate and sign the informed consent. Inclusion criteria for normal control group 1.18-65 years old male and female; 2.Physical examination excludes functional gastrointestinal diseases and other organic diseases. 3.Those who know about the study, volunteer to participate and sign the informed consent. 

排除标准:

1.在参与试验前15日内常规使用胃肠道药物; 2.可能存在影响胃肠道症状的器质性疾病患者,如胃肠道任何部位的恶性肿瘤、胃肠道感染、糖尿病、进食障碍等,接受过减肥手术、胃肠道任何部位切除患者; 3.晕针; 4.金属过敏; 5.患严重并发症或需紧急治疗的疾病; 6.怀孕或哺乳或计划怀孕的妇女、在研究期间怀孕; 7.接受药物成瘾或酒精中毒治疗或具有药物成瘾或酒精中毒病史的患者; 8.计划参加或已经参加其他临床研究; 9.由于其他原因被研究者认为不适合参加研究的人。 

Exclusion criteria:

1.Taking routine use of gastrointestinal drugs within 15 days prior to the trial; 2.Patients with organic diseases that may affect gastrointestinal symptoms, such as malignant tumors in any part of the gastrointestinal tract, gastrointestinal infections, diabetes mellitus, eating disorders, etc., have undergone weight-loss surgery and gastrointestinal resection at any part of the patients; 3.Fainting in needling process; 4.Metal allergy; 5.Suffering from serious complications or diseases requiring urgent treatment; 6.Women who are pregnant or breast-feeding or planning to become pregnant, who are pregnant during the study period; 7.Patients receiving treatment for drug addiction or alcoholism or with a history of drug addiction or alcoholism; 8.Planned to participate in or have participated in other clinical studies; 9.For other reasons, it is considered unsuitable for researchers to participate in the study. 

研究实施时间:

Study execute time:

From2018-11-29To 2019-12-31 

干预措施:

Interventions:

组别:

FD针刺试验组

样本量:

10

Group:

FD acupuncture test group

Sample size:

干预措施:

针刺特定穴位

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

健康对照组

样本量:

10

Group:

Healthy control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学第二医院 

单位级别:

三甲 

Institution
hospital:

the Second Hospital of ShanDong University  

Level of the institution:

Third-grade 

测量指标:

Outcomes:

指标中文名:

血浆外泌体中microRNA

指标类型:

主要指标 

Outcome:

microRNA of plasma exosomes

Type:

Primary indicator 

指标中文名:

成人功能性胃肠病诊断问卷

指标类型:

主要指标 

Outcome:

Adult Functional Gastroenteropathy Diagnostic Questionnaire

Type:

Primary indicator 

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:

标本中文名:

唾液

组织:

Sample Name:

Saliva

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

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

由统计人员通过软件产生随机数

性别:

男女均可

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

Generating random numbers by statisticians through software

Gender:

Both

盲法:

Blinding:

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):

使用临床研究电子管理公共平台ResMan

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

ResMan

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):

ResMan

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

ResMan

创建人:

Creater Name:

 2018-12-07
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