针灸治疗慢性萎缩性胃炎临床评价研究

注册号:

Registration number:

AMCTR-IPC-19000244 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 18:47:33 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针灸治疗慢性萎缩性胃炎临床评价研究 

Public title:

Clinical Evaluation of Acupuncture and Moxibustion in the Treatment of Chronic Atrophic Gastritis 

研究课题的正式科学名称:

艾灸与针刺作用特点、效应响应异同的基础与临床研究 

Scientific title:

Basic and Clinical Study on the Characteristics and Responses of Moxibustion and Acupuncture 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900020487 

申请注册联系人:

黄河 

研究负责人:

常小荣 

Applicant:

Huang He 

Study leader:

Chang Xiaorong 

申请注册联系人电话:

Applicant telephone:

+86 15700776864 

研究负责人电话:

Study leader's telephone:

+86 13607448463 

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:

297555487@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xrchang1956@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:

湖南省长沙市雨花区韶山中路95号 

研究负责人通讯地址:

湖南省长沙市含浦科教园区 

Applicant address:

95 Shaoshan Middle Road, Yuhua District, Changsha, Hu'nan, China 

Study leader's address:

Hunan University of Chinese Medicine, Changsha City, Hunan 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:

湖南中医药大学 

Applicant's institution:

Hu'nan 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:

HN-LL-KY-2016-001-03 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

湖南中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Hu'nan University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-11 

研究实施负责(组长)单位:

湖南中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Hunan University of Chinese Medicine 

研究实施负责(组长)单位地址:

湖南省长沙市雨花区韶山中路95号 

Primary sponsor's address:

95 Shaoshan Middle Road, Yuhua District, Changsha, Hu'nan, 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):

Country:

中国

Province:

Hunan

City:

单位(医院):

湖南中医药大学

具体地址:

湖南省长沙市雨花区韶山中路95号

Institution
hospital:

Hu'nan University of Chinese Medicine

Address:

95 Shaoshan Middle Road, Yuhua District, Changsha, Hu'nan, China

经费或物资来源:

国家重点基础研究发展计划 (973计划) 

Source(s) of funding:

National Key Basic Research and Development Plan of China (973 Program) 

研究疾病:

慢性萎缩性胃炎 

Target disease:

Chronic atrophic gastritis 

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:

I期临床试验 

Study phase:

Phase I 

研究目的:

本课题以揭示艾灸与针刺作用的异同为目标,通过严格的临床对照研究,结合基础实验研究,从组织、细胞、分子等多层次比较艾灸与针刺的不同作用特点,从“局部始动-外周传导?中枢整合-靶器官响应”诠释艾灸与针刺内源性调节效应的响应特征,并对艾灸与针刺作用的异同作出科学的结论,初步阐明“针所不为,灸之所宜”的科学内涵。 

Objectives of Study:

This subject aims at revealing the similarities and differences between moxibustion and acupuncture. Through rigorous clinical comparative study and basic experimental study, the characteristics of different functions of moxibustion and acupuncture are compared from tissue, cell and molecule levels. The response characteristics of endogenous regulatory effects of moxibustion and acupuncture are interpreted from "local initiation-peripheral conduction-central integration-target organ response", and the characteristics of endogenous regulatory effects of moxibustion and acupuncture are also explained. Conclude the similarities and differences of the effects of acupuncture and moxibustion 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1. 20岁≦年龄≦75岁; 2.符合慢性萎缩性胃炎西医诊断标准; 3.符合慢性萎缩性胃炎中医诊断标准且证型为肝胃不和或脾胃虚 寒型; 4.纳入试验前1个月内检查证实诊断; 5.自愿参加本项研究,并签署知情同意书。 

Inclusion criteria

1. Aged 20-75 years old; 2. Meet the diagnostic criteria of chronic atrophic gastritis in Western medicine; 3. With traditional Chinese medicine symptom disharmony between liver and stomach or deficiency of spleen and stomach. Cold type; 4. The diagnosis was confirmed by examination within one month before the inclusion of the test. 5. Volunteer to participate in the study and sign the informed consent. 

排除标准:

1.合并精神、智力或语言障碍者; 2.合并消化性溃疡、胃粘膜有重度异型增生或病理诊断有恶变者; 3.合并心、脑、肝、肾和造血系统等严重原发性疾病者; 4.孕妇、哺乳期妇女及近6个月有妊娠要求者; 5.正在参加其它临床试验者。 

Exclusion criteria:

1. Patients with integrating mental, intellectual or linguistic disorders; 2. Complicated with peptic ulcer, severe dysplasia of gastric mucosa or malignant change in pathological diagnosis; 3. Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system; 4. Pregnant women, lactating women and those who have pregnancy requirements in the past six months; 5. Participants in other clinical trials. 

研究实施时间:

Study execute time:

From2019-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Group 1

Sample size:

干预措施:

艾灸

干预措施代码:

Intervention:

moxibustion

Intervention code:

组别:

对照组1

样本量:

50

Group:

Group 2

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

对照组2

样本量:

50

Group:

Group 3

Sample size:

干预措施:

药物

干预措施代码:

Intervention:

Take medicine

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):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南中医药大学第一附属医院 

单位级别:

三级甲等中医院 

Institution
hospital:

The First Affiliated Hospital of Hunan University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南中医药大学第二附属医院 

单位级别:

三级甲等中医院 

Institution
hospital:

The Second Affiliated Hospital of Hunan University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南中医药研究院附属医院 

单位级别:

三级甲等中医院 

Institution
hospital:

Hunan Academy of Traditional Chinese Medicine Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

岳阳市中医医院 

单位级别:

三级甲等中医院 

Institution
hospital:

Yueyang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

浏阳市中医医院 

单位级别:

三级甲等中医院 

Institution
hospital:

Liuyang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

健康相关生活质量评分

指标类型:

主要指标 

Outcome:

healthrelated quality of life, HRQOL

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:

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 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表法

性别:

男女均可

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

Random Number Table

Gender:

Both

盲法:

no

Blinding:

no

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:

即时公开/Real time access

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):

网络平台,www.cnki.net

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

web-based public database, www.cnki.net

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, CRF

创建人:

Creater Name:

 2019-01-04
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