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“益神方”结合针灸治疗老年轻度认知功能障碍多中心、随机对照研究
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注册号:

Registration number:

ChiCTR-INR-17011569 

最近更新日期:

Date of Last Refreshed on:

2018-02-28 

注册时间:

Date of Registration:

2017-06-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

“益神方”结合针灸治疗老年轻度认知功能障碍多中心、随机对照研究 

Public title:

Combination of Yishen Granule and Acupuncture for older adults with mild cognitive impairment: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

“益神方”结合针灸治疗老年轻度认知功能障碍多中心、随机对照研究 

Scientific title:

Combination of Yishen Granule and Acupuncture for older adults with mild cognitive impairment: a randomized controlled trial 

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:

陈悦琦 

研究负责人:

徐建 

Applicant:

Yueqi Chen 

Study leader:

Jian Xu 

申请注册联系人电话:

Applicant telephone:

+86 18221296928 

研究负责人电话:

Study leader's telephone:

+86 13901781509 

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:

chenballoon@163.com 

研究负责人电子邮件:

Study leader's E-mail:

0296@szy.sh.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:

上海市闸北区芷江中路274号 

研究负责人通讯地址:

上海市闸北区芷江中路274号 

Applicant address:

274 Middle Zhijiang Road, Shanghai, Zhabei District, China 

Study leader's address:

274 Middle Zhijiang Road, Shanghai, Zhabei District, 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:

上海市中医医院 

Applicant's institution:

Shanghai Municipal Hospital 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:

2017SHL-KY-05 

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:

上海市中医医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-06 

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:

上海市中医医院 

Primary sponsor:

Shanghai Municipal Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市闸北区芷江中路274号 

Primary sponsor's address:

274 Middle Zhijiang Road, Shanghai, Zhabei District, 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):

闸北区

Country:

China

Province:

Shanghai

City:

Zhabei District

单位(医院):

上海市中医医院

具体地址:

上海市闸北区芷江中路274号

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address:

274 Middle Zhijiang Road, Shanghai, Zhabei District, China

国家:

中国

省(直辖市):

上海市

市(区县):

闸北区

Country:

China

Province:

Shanghai

City:

单位(医院):

闸北区中医医院

具体地址:

闸北区延长中路288号

Institution
hospital:

Zhabei District Hospital of traditional Chinese Medicine

Address:

288 Middle Yanchang Road, Shanghai, Zhabei District, China

国家:

中国

省(直辖市):

上海市

市(区县):

浦东新区

Country:

China

Province:

Shanghai

City:

Pudong New Area

单位(医院):

上海市东方医院

具体地址:

上海市浦东新区即墨路150号

Institution
hospital:

Shanghai East Hospital

Address:

150 Jimo Road, Shanghai, Pudong New Area

经费或物资来源:

上海市卫生和计划生育委员会 

Source(s) of funding:

Shanghai Municipal Commission of Health and Family Planning 

研究疾病:

轻度认知功能障碍 

Target disease:

mild cognitive impairment  

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:

分别评估针刺及中药对老年轻度认知功能障碍的治疗作用。评估两者结合对老年轻度认知功能障碍的治疗作用。 

Objectives of Study:

The aim is to evaluate the therapeutic effects of acupuncture and Yishen Granule (YSG) for older adults with MCI respectively, and to clear the effect of acupuncture combined with Chinese herbs medicine for MCI. 

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)年龄在65-85岁 (2)以记忆障碍为主诉,且有知情者证实。 (3)除记忆障碍外,其他认知功能相对完好或轻度受损。 (4)日常生活不受影响。 (5)达不到痴呆的诊断标准。 (6)要排除可引起脑功能障碍的其他疾病。 (7)量表评估:总体衰退量表(GDS)2~3分、临床痴呆量表(CDR)0.5分,记忆分值在年龄和教育匹配对照组的1.5倍标准差以下、简明精神状态量表(MMSE)>24分或mattis痴呆评价表(DRS)>123分。 (8)能理解各项日间功能量表条文并完成评定; (9)同意参加调查并签署书面知情同意书。 

Inclusion criteria

1. Aged 65–85 years; 2. Complaint of allomnesia, which can be obtained from an informant who knows the patient well; 3. In addition to memory impairment, other cognitive functions are relatively intact or mildly impaired 4. The cognitive impairment is not severe enough to interfere with daily life; 5. Can't meet the diagnostic criteria for dementia; 6. Without other diseases which can cause brain disorder; 7. GDS score between 2-3, CDR score=0.5, MMSE score>24, DRS score>123, memory test score<1.5 SD according to the age and education matched control group; 8. Able to understand and complete the scale evaluations; 9. Sign the written informed consent form. 

排除标准:

①CDR评定为正常或者痴呆者; ②汉密尔顿抑郁量表评分>18分; ③目前患者有精神分裂症、分裂情感性障碍或原发性成人情感性障碍,包括先前成人情感性障碍病史者。或伴有严重的神经缺损患者,如各种失语,失认者; ④患者有AD、中枢神经系统感染、创伤后痴呆、中毒代谢性脑病、Huntington氏病、多发性硬化、Parkinson氏病的诊断在记忆衰退之前,精神发育不全、原 发的未经治疗的内分泌疾病; ⑤合并有心、脑、肝、肾和造血系统等严重原发疾病患者; ⑥有严重消化不良,或胃肠道梗阻,或胃和十二指肠溃荡的病人,以及影响药物吸收的其他胃肠道疾病的病人; ⑦年龄在65岁以下或85岁以上者; ⑧对本研究药物过敏者; ⑨近2周曾系统接受过中、西医益智药物治疗的患者。 

Exclusion criteria:

1. Participants who are assessed as normal or dementia by the CDR (Clinical Dementia Rating); 2. Participants with a HAMD (Hamilton Depression Scale) score>8; 3. Participants with schizophrenia, Schizoaffective Disorder, primary affective disorder (including the history of affective disorder), or Participants with severe neural disorder (such as aphasia or agnosia); 4. Participants who were diagnosed as AD, central nervous system infections, post traumatic dementia, toxic encephalopathy, metabolic encephalopathy, Huntington's disease, multiple sclerosis or Parkinson's disease before memory decline, or Participants with untreated primary endocrine disease; 5. Participants with severe primary disease of the cardiovascular, hepatic, renal, or hematopoietic system; 6. Participants suffering from gastrointestinal diseases that affect drug absorption (such as severe dyspepsia, gastrointestinal obstruction or Gastric ulcer); 7. Participants who are allergic to the study granule; 8. Participants who have taken Western and/or Oriental medicine in the past 2 weeks to improve the cognitive function; 

研究实施时间:

Study execute time:

From2018-02-01To 2020-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

60

Group:

Group A

Sample size:

干预措施:

中药+针灸

干预措施代码:

Intervention:

acupuncture+Yishen Granule

Intervention code:

组别:

B组

样本量:

60

Group:

Group B

Sample size:

干预措施:

针灸+安慰剂

干预措施代码:

Intervention:

acupuncture+placebo

Intervention code:

组别:

C组

样本量:

60

Group:

Group C

Sample size:

干预措施:

中药+假针组

干预措施代码:

Intervention:

sham acupuncture+Yishen Granule

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 

市(区县):

闸北区 

Country:

China 

Province:

Shanghai 

City:

Zhabei District 

单位(医院):

上海市中医医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

Pudong New Area 

单位(医院):

上海市东方医院 

单位级别:

三甲 

Institution
hospital:

Shanghai East Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

闸北区 

Country:

China 

Province:

Shanghai 

City:

Zhabei District 

单位(医院):

闸北区中医医院 

单位级别:

二甲 

Institution
hospital:

Zhabei District Hospital of traditional Chinese Medicine  

Level of the institution:

Secondary A hospital 

测量指标:

Outcomes:

指标中文名:

蒙特利尔认知量表

指标类型:

主要指标 

Outcome:

Montreal Cognitive Assessment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易智力状态检查量表

指标类型:

次要指标 

Outcome:

Mini-Mental State Examination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

事件相关电位检查

指标类型:

次要指标 

Outcome:

event-related potential

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 85 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):

本试验采用中央随机系统进行随机分组(委托上海中医药大学制作)。各中心分别由一位独立研究人员进行相关操作。研究人员通过浏览器登入相关网站,在筛选模块输入符合纳入标准的受试者的基本信息(如出生日期、性别等),取得受试者唯一识别号。随后在随机化模块对患者进行随机化分组。随机数及分组方案将会以短信或邮件方式反馈给研究人员。

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

The Central Randomization will be performed by the Shanghai University of Traditional Chinese Medicine. Randomization will be done by an independent researcher. The information of patients will be sent to the center via the website and mobile messages. Randomization will be performed automatically under the control

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

临床试验公共管理平台ResMan

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

www.medresman.org

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:

数据包括原始记录、病例记录表等数据,采用ResMan数据库

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

The data includes raw records, case records , et al. The ResMan database will be used.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-06-05
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