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中药敷脐疗法治疗肝硬化腹水的临床研究
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注册号:

Registration number:

ChiCTR-INR-16007686 

最近更新日期:

Date of Last Refreshed on:

2016-01-01 

注册时间:

Date of Registration:

2016-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中药敷脐疗法治疗肝硬化腹水的临床研究 

Public title:

Clinical research for the umbilical therapy of traditional Chinese medicine on the patients of ascites due to cirrhosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中药敷脐疗法治疗肝硬化腹水的临床研究 

Scientific title:

Clinical research for the umbilical therapy of traditional Chinese medicine on the patients of ascites due to cirrhosis 

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:

江锋 

研究负责人:

江锋 

Applicant:

Feng Jiang 

Study leader:

Feng Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13811808029 

研究负责人电话:

Study leader's telephone:

+86 13811808029 

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:

jiangfengtcm@139.com 

研究负责人电子邮件:

Study leader's E-mail:

jiangfengtcm@hotmail.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:

北京市东城区海运仓5号 

研究负责人通讯地址:

北京市东城区海运仓5号 

Applicant address:

5 Haiyuncang Street, Dongcheng District, Beijing 

Study leader's address:

5 Haiyuncang Street, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medcine 

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:

ECPJ-BDY-2015-69 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

IRB of Dongzhimen Hospital affiliated to Beijing University of Chinese Medcine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-12-11 

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:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medcine 

研究实施负责(组长)单位地址:

北京市东城区海运仓5号 

Primary sponsor's address:

5 Haiyuncang Street, Dongcheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medcine

Address:

5 Haiyuncang Street, Dongcheng District, Beijing

经费或物资来源:

北京市科学技术委员会 

Source(s) of funding:

Beijing municipal science & technology commission 

研究疾病:

肝硬化腹水 

Target disease:

ascites due to cirrhosis 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过严格的前瞻性随机对照临床试验,客观评价中药敷脐疗法治疗肝硬化腹水的疗效和安全性;进一步完善中药敷脐治疗肝硬化腹水的规范化方案及技术操作规范,为提高中医药治疗肝硬化腹水的临床疗效提供有效手段。 

Objectives of Study:

Through rigorous prospective randomized controlled clinical trial, objective to evaluate the effect and security of the umbilical therapy of traditional Chinese medicine on the patients of ascites due to cirrhosis; To further improve the standardized scheme and technical specifications of the umbilical treatment of cirrhosis ascites, in order to provide effective means on improve the clinical curative effect of traditional Chinese medicine treatment of cirrhosis ascites. 

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2-3级肝硬化腹水的西医诊断; (2)年龄在18-75岁之间,性别不限; (3)患者自愿签署知情同意书。 

Inclusion criteria

(1) According to the diagnostic standards of liver cirrhosis ascites of grade 2-3; (2) Aged between 18-75 years old, gender not limited; (3) Patients voluntarily signed informed consent. 

排除标准:

(1)肝硬化代偿期及1级肝硬化腹水患者; (2)肝硬化失代偿期合并消化道出血、肝性脑病、肝肾综合征等严重合并症者; (3)合并心脑血管、肺、肾、神经和血液系统等严重疾病或肿瘤、精神疾病患者; (4)妊娠或准备妊娠妇女,哺乳期妇女; (5)过敏体质或对敷脐药物中的已知成分有过敏史者; (6)正在参加或1个月内参加过其他临床试验的患者。 

Exclusion criteria:

(1) Liver cirrhosis compensatory period and grade 1 patients with liver cirrhosis ascites; (2) Cirrhosis of the liver decompensation period merger gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome and other serious complications; (3) Combination of severe disease of heart head blood-vessel, lung, kidney, nerve and blood system and other serious illness or tumors, patients with mental illness; (4) Pregnancy or ready to pregnant women and nursing mothers; (5) Allergic constitution or to apply the umbilical drugs the known component has a history of allergies; (6) Taking part in or participated within a month in other clinical trials. 

研究实施时间:

Study execute time:

From2015-06-01To 2018-09-30 

干预措施:

Interventions:

组别:

试验组

样本量:

41

Group:

Expirement group

Sample size:

干预措施:

中药敷脐疗法

干预措施代码:

Intervention:

the umbilical therapy of traditional Chinese medicine

Intervention code:

组别:

试验组

样本量:

41

Group:

Expirement group

Sample size:

干预措施:

西医基础治疗

干预措施代码:

Intervention:

the foundation treatment with Western medicine

Intervention code:

组别:

对照组

样本量:

41

Group:

control group

Sample size:

干预措施:

中药安慰剂敷脐

干预措施代码:

Intervention:

the umbilical therapy of placebo of traditional Chinese medicine

Intervention code:

组别:

对照组

样本量:

41

Group:

control group

Sample size:

干预措施:

西医基础治疗

干预措施代码:

Intervention:

the foundation treatment with Western medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三级甲等医院 

Institution
hospital:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medcine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市通州区中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Beijing tongzhou district hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市平谷区中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Pinggu Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

腹水深度

指标类型:

主要指标 

Outcome:

The depth of ascites

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹围

指标类型:

主要指标 

Outcome:

abdominal perimeter

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿量

指标类型:

主要指标 

Outcome:

urine volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状评分

指标类型:

主要指标 

Outcome:

the symptomatic score of TCM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性肝病量表

指标类型:

主要指标 

Outcome:

CLDQ

Type:

Primary indicator 

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:

腹水

组织:

Sample Name:

ascites

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:

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:

尿液

组织:

Sample Name:

urine

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 75 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):

中央随机系统

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

The Central Randomization System

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):

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-01-01
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