ChiCTR-TRC-12001972 版本V1.1 版本创建时间2015/8/3 20:45:15 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-12001972 

最近更新时间:

Date of Last Refreshed on:

2015/8/3 20:44:07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

中风亚急性期(恢复早期)中西医结合康复治疗的临床研究 

Public title:

Clinical Research on Integrated Rehabilitation with Traditional Chinese and Western Medicine on Subacute stage of Ischemic Stroke 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

中风亚急性期(恢复早期)中西医结合康复治疗的临床研究 

Scientific title:

Clinical Research on Integrated Rehabilitation with Traditional Chinese and Western Medicine on Subacute stage of Ischemic Stroke 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

2011ZGG003 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈利芳 

研究负责人:

方剑乔 

Applicant:

Lifang Chen 

Study leader:

Jianqiao Fang 

申请注册联系人电话:

Applicant telephone:

+86 13957157278 

研究负责人电话:

Study leader's telephone:

+86 13606707532 

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:

clfang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fangjianqiao@yahoo.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:

浙江省杭州市莫干山路219号 

研究负责人通讯地址:

浙江省杭州市莫干山路219号 

Applicant address:

219 Moganshan Road, Hangzhou, Zhejiang 

Study leader's address:

219 Moganshan Road, Hangzhou, Zhejiang 

申请注册联系人邮政编码:

Applicant postcode:

310005 

研究负责人邮政编码:

Study leader's postcode:

310005 

申请人所在单位:

浙江中医药大学附属第三医院 

Applicant's institution:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University 

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:

ZSLL-KY-2012-001 

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:

浙江中医药大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Third Affiliated Hospital of Zhejiang Chinese Medicine University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-02-10 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

浙江中医药大学附属第三医院 

Primary sponsor:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University 

研究实施负责(组长)单位地址:

浙江省杭州市莫干山路219号 

Primary sponsor's address:

219 Moganshan Road, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

浙江省中医药管理局

具体地址:

浙江省杭州市庆春路216号

Institution
hospital:

Zhejiang Bureau of Traditional Chinese Medicine

Address:

219 Moganshan Road, Hangzhou, Zhejiang

经费或物资来源:

浙江省中医药防治重大疾病攻关计划 

Source(s) of funding:

Zhejiang provincal key program for traditional Chinese medicine in prevention and treatment of major diseases 

研究疾病:

中风亚急性期 

Target disease:

Subacute stage of stroke 

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:

制定中风亚急性期中西医结合康复治疗方案,并对中西医结合康复治疗中风亚急性期进行疗效评价。 

Objectives of Study:

To assess the effects of integrated rehabilitation with traditional chinese and western medicine in the treatment of subacute stage of stroke. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合西医脑卒中和中医中风病诊断标准; 发病在30-40天; 性别不限,年龄在35-80岁(≥35岁;且≤80岁); NIHSS评分4-24分; 第一次发病或有卒中史但无严重残疾,mRS评分≤1; 自愿加入试验,签署知情同意书。 

Inclusion criteria

1. Patients with stroke according to the criteria of both Western medicine and Traditional Chinese Medicine; 2. The stroke onset 30-40 days; 3. Age ranged 35~80 year; 4. The NIHSS score 4-24; 5. The first incidence or history of stroke without disability, mRS score <=1. 

排除标准:

1.接受溶栓治疗的患者; 2.正在或近3个月参加其他临床试验者; 3.合并有心、肝、肾和造血系统等严重的原发性疾病以及精神病患者; 4.妊娠或哺乳期妇女; 5.先天残障患者; 

Exclusion criteria:

1. Patients received thrombolytic therapy; 2. Patients participated in other clinical trials within last three months; 3. Completed with heart, liver, kidney and hematopoietic system primary and secondary serious diseases, as well as the mentally ill; 4. Pregnancy or breast-feeding women; 5. Patients with congenital disabilities. 

研究实施时间:

Study execute time:

From2012-03-01To 2014-09-21 

干预措施:

Interventions:

组别:

试验组

样本量:

180

Group:

Experimental group

Sample size:

干预措施:

西医基础治疗+针灸治疗、中药治疗+康复治疗

干预措施代码:

Intervention:

Basic treatment and acupuncture, Chinese medicine and rehabilitation treatment

Intervention code:

组别:

对照组

样本量:

180

Group:

Control group

Sample size:

干预措施:

西医基础治疗+常规康复治疗

干预措施代码:

Intervention:

Basic treatment and rehabilitation treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第三医院 

单位级别:

三级乙等 

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市中医院 

单位级别:

三级乙等 

Institution
hospital:

Hangzhou Traditional Chinese Medical Hospital  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

嘉兴市中医院 

单位级别:

三级乙等 

Institution
hospital:

Jiaxing Traditional Chinese Medical Hospital  

Level of the institution:

Tertiary B hospital 

测量指标:

Outcomes:

指标中文名:

病死率

指标类型:

主要指标 

Outcome:

Mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经功能缺损程度的评价

指标类型:

主要指标 

Outcome:

NIHSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简式Fugl—Meyer运动功能评分

指标类型:

主要指标 

Outcome:

FMA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能评价

指标类型:

主要指标 

Outcome:

MMSE, MoCA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吞咽功能评价

指标类型:

主要指标 

Outcome:

Depression cropland of swallowing ability evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁状态评价

指标类型:

主要指标 

Outcome:

SDS, HAM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卫生经济学评价

指标类型:

次要指标 

Outcome:

Health economics evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评价

指标类型:

次要指标 

Outcome:

Safety evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

依从性评价

指标类型:

次要指标 

Outcome:

Compliance evaluation

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:

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 35 years
最大 Max age 80 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

采用SPSS软件将360例患者随机分成2组(试验组和对照组)

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

360 patients were randomly divided into 2 groups using SPSS software(experimental group and control

UTN(全球唯一识别码):

盲法:

盲法评价、盲法统计(结果评估人员和统计人员由不知道分组信息的人员担任)

Blinding:

Blind evaluation,blind statistics(the assessment and statistical personnel don't know about the group information)

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

浙江中医药大学

Data collection Institution:

Zhejiang Chinese Medicine University

资料管理单位:

浙江中医药大学

Data management Institution:

Zhejiang Chinese Medicine University

资料分析单位:

浙江中医药大学

Data analysis Institution:

Zhejiang Chinese Medicine University

注册人:

Name on Registration:

 2012-02-25