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辨证施灸方案改善尿毒症血透患者虚弱综合征的临床研究
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注册号:

Registration number:

ChiCTR-IOR-17013931 

最近更新日期:

Date of Last Refreshed on:

2017-12-14 

注册时间:

Date of Registration:

2017-12-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

辨证施灸方案改善尿毒症血透患者虚弱综合征的临床研究 

Public title:

Dialectical Moxibustion Treatment of Uremia Patients on Hemodialysis With Frailty Syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

辨证施灸方案改善尿毒症血透患者虚弱综合征的临床研究 

Scientific title:

Dialectical Moxibustion Treatment of Uremia Patients on Hemodialysis With Frailty Syndrome 

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:

何流 

研究负责人:

邱模炎 

Applicant:

He Liu 

Study leader:

Qiu Mo-tan 

申请注册联系人电话:

Applicant telephone:

+86 15010006378 

研究负责人电话:

Study leader's telephone:

+86 13601382665 

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:

riverccmu@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

13601382665@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:

北京市朝阳区望京南环中路6号 

研究负责人通讯地址:

北京市朝阳区望京南环中路6号 

Applicant address:

6 Wangjing Middle Road, Chaoyang District, Beijing, China 

Study leader's address:

6 Wangjing Middle Road, Chaoyang District, Beijing, 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:

中国中医科学院望京医院 

Applicant's institution:

Wang Jing Hospital of China Academy of Chinese Medical Sciences 

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:

WJEC-KT-2017-001-P002 

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:

中国中医科学院望京医院医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of Wang Jing Hospital of China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

贾忠武 

Contact Name of the ethic committee:

Jia Zhong-wu 

伦理委员会联系地址:

北京市朝阳区花家地街中国中医科学院望京医院 

Contact Address of the ethic committee:

Wang Jing Hospital of China Academy of Chinese Medical Sciences, Hua Jia Di Street, Chaoyang District, Beijing, China 

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:

中国中医科学院望京医院 

Primary sponsor:

Wang Jing Hospital of China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市朝阳区望京南环中路6号 

Primary sponsor's address:

6 Wangjing Middle Road, Chaoyang District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区望京南环中路6号

Institution
hospital:

Wang Jing Hospital of China Academy of Chinese Medical Sciences

Address:

6 Wangjing Middle Road, Chaoyang District, Beijing, China

经费或物资来源:

北京市科委课题 

Source(s) of funding:

Beijing Municiple Science and Technology Commission Project 

研究疾病:

血透患者虚弱综合征 

Target disease:

Frailty Syndrome of Hemodialysis Patients 

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:

(1)评价辨证施灸方案对尿毒症血透患者虚弱综合征的改善作用; (2)评价辨证施灸方案对血透虚弱综合征患者生存质量的改善作用; (3)评价辨证施灸方案对血透虚弱综合征患者脾肾气虚证和脾肾阳虚证的中医证候疗效; (4)形成可供推广应用的治疗血透患者虚弱综合征的中医辨证施灸方案。 

Objectives of Study:

(1) To evaluate the efficacy of dialectical moxibustion on frailty syndrome in uremic hemodialysis patients; (2) To evaluate the efficacy of dialectical moxibustion on quality of life in uremic hemodialysis patients with frailty syndrome; (3) To evaluate the TCM efficacy of dialectical moxibustion on spleen-kidney qi deficiency syndrome and spleen-kidney yang deficiency syndrome in hemodialysis patients with frailty syndrome; (4) The promotion and application of dialectical moxibustion to treat hemodialysis patients with frailty syndrome. 

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)患者规律血液透析≥3个月。 (2)符合上述虚弱综合征诊断标准者。 (3)符合上述中医证候诊断标准者。 (4)意识清楚,无精神病史或人格障碍。 (5)能理解调查内容。 (6)患者对中西医治疗医嘱依从性良好。 (7)患者签署知情同意书。 (8)受试年龄范围为18—80岁。 

Inclusion criteria

(1) With regular hemodialysis ≥ 3 months; (2) To meet the diagnostic criteria of frailty syndrome; (3) To meet the diagnostic criteria of TCM syndrome; (4) Consciousness, no history of mental illness or personality disorder; (5) To understand the survey content; (6) Good compliance with Chinese and Western medical treatment orders; (7) To sign informed consent; (8) Aged from 18 to 80 years old. 

排除标准:

(1)患者血液透析不足3个月。 (2)合并严重心脑血管疾病、感染、恶性肿瘤、胃肠道与肝脏疾病、骨折者。 (3)左卡尼汀过敏者,或有癫痫史者。 (4)有皮肤过敏史,或取穴部位有感染灶,或伴有糖尿病而血糖控制不达标者。 (5)对中西医治疗医嘱依从性不佳。 (6)患者无法合作或不签署知情同意书。 

Exclusion criteria:

(1) With regular hemodialysis less than 3 months; (2) Combined with severe cardiovascular and cerebrovascular diseases, infections, malignant tumors, gastrointestinal and liver diseases, fractures; (3) Allergic to L-carnitine, or with history of epilepsy; (4) Have history of skin allergies, or have infected stoves in acupoints, or have diabetes with blood glucose control not up to standard; (5) Poor compliance with Chinese and Western medical treatment orders; (6) Do not cooperate or sign informed consent. 

研究实施时间:

Study execute time:

From2016-06-01To 2019-05-31 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-03-31 

干预措施:

Interventions:

组别:

试验组

样本量:

56

Group:

test group

Sample size:

干预措施:

辨证施灸

干预措施代码:

Intervention:

dialectical moxibustion

Intervention code:

组别:

对照组

样本量:

56

Group:

Control group

Sample size:

干预措施:

左卡尼汀注射液

干预措施代码:

Intervention:

L-carnitine injection

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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院望京医院 

单位级别:

三级甲等医院 

Institution
hospital:

Wang Jing Hospital of China Academy of Chinese Medical Sciences  

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):

航空总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Aviation General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

虚弱综合征评价指标

指标类型:

主要指标 

Outcome:

evaluation index of frailty syndrome

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量

指标类型:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效

指标类型:

次要指标 

Outcome:

efficacy of TCM syndrome

Type:

Secondary 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:

组织:

Sample Name:

no

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 80 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):

由不参与课题的第三方科研人员运用计算机SPSS19.0软件包进行随机,设定种子数,通过Random Number Generator产生随机数字,编程结果不可重复,随机数字产生后,随机数字表由第三方管理并分配随机号。

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

Third-party researchers who do not participate in the project use the software package SPSS19.0 to randomly divide into groups, set the number of seeds and generate random numbers through Random Number Generator. The programming results are not repeatable. After the random numbers are generated, the random number&#

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):

试验结束后公开原始数据,以电子表格Excel的方式展示

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

announce the original data after the end of the trial in the form of Excel

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:

完成病例记录表的设计。

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

Complete the design of case record form.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-14
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