中风中医临床疗效评价标准研究

注册号:

Registration number:

AMCTR-OPC-18000228 

注册号获得时间:

Date of releasing the registration number:

2018/11/20 10:31:32 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

中风中医临床疗效评价标准研究 

Public title:

Study on the evaluation standard of clinical curative effect of apoplexy 

研究课题的正式科学名称:

中风中医临床疗效评价标准研究 

Scientific title:

Study on the evaluation standard of clinical curative effect of apoplexy 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

黄杏贤 

研究负责人:

杨卓欣 

Applicant:

Huang xingxian 

Study leader:

Yang zhuoxin 

申请注册联系人电话:

Applicant telephone:

13632822278 

研究负责人电话:

Study leader's telephone:

13823118811 

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:

732545909@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

szyangzhuoxin@qq.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:

中国广东省深圳市福田区福华路1号 

研究负责人通讯地址:

中国广东省深圳市福田区福华路1号 

Applicant address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,China 

Study leader's address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,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:

深圳市中医院 

Applicant's institution:

Shenzhen Traditional Chinese Medicine hospital 

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:

深中医伦审(研)[2017]3 

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:

广州中医药大学深圳附属医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of shenzhen Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-27 

研究实施负责(组长)单位:

深圳市中医院 

Primary sponsor:

Shenzhen Traditional Chinese Medicine hospital 

研究实施负责(组长)单位地址:

深圳市中医院 

Primary sponsor's address:

Shenzhen Traditional Chinese Medicine hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市中医院

具体地址:

中国广东省深圳市福田区福华路1号

Institution
hospital:

Shenzhen Traditional Chinese Medicine hospital

Address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,China

经费或物资来源:

深圳市科技计划项目 

Source(s) of funding:

Technology plan in Shenzhen 

研究疾病:

中风 

Target disease:

Stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

本项目以中风二级预防作为切入点,利用针灸临床科研信息共享技术,以海量临床信息为基础,开展基于真实世界的临床实际数据的科学研究,构建针灸综合干预中风的大型临床诊疗数据库。利用数据挖掘与建模技术,提取中风风险因子,构建整合中风风险因素的中风不同分期的中医临床疗效评价体系。利用临床疗效比较研究,探索针灸综合干预的中风诊治规律,建立基于临床科研一体化的针灸综合干预中风的诊疗方案。 

Objectives of Study:

This project takes secondary prevention of apoplexy as the breakthrough point, uses the sharing technology of clinical scientific research information of acupuncture and moxibustion, and based on massive clinical information, carries out scientific research based on the actual clinical data of the real world, and constructs a large clinical diagnosis and treatment database of comprehensive intervention of acupuncture and moxibustion in apoplexy. By using data mining and modeling technology, stroke risk factors were extracted, and the clinical efficacy evaluation system of TCM integrating stroke risk factors in different stages was constructed. Using the comparative study of clinical efficacy, we explored the rule of diagnosis and treatment of Apoplexy by comprehensive intervention of acupuncture and moxibustion, and established the diagnosis and treatment scheme of Apoplexy by comprehensive intervention of acupuncture and moxibustion based on the integration of clinical scientific research. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1、符合脑卒中的诊断标准,并且经颅脑CT或MR明确诊断者。 2、年龄在18岁至70岁之间,意识清醒者。 3、发病在2周-6个月,即中风恢复期患者。 4、排除外伤、颅内肿瘤和感染、脑脱髓鞘病变、严重心肺肝肾功能不全及其他原因导致肢体、器官残缺或者畸形。 5、患者知情,并能配合治疗、检查及随访。 

Inclusion criteria

1. It is in line with the diagnostic criteria of stroke and diagnosed by CT or MR. 2. between 18 and 70 years old, conscious. 3. the onset of 2 weeks -6 months, stroke recovery patients. 4. Exclude trauma, intracranial tumors and infections, demyelinating brain lesions, severe cardiopulmonary, liver and kidney dysfunction and other causes leading to limb and organ disabilities or deformities. 5. Patients are informed and can cooperate with treatment, examination and follow-up. 

排除标准:

1.不符合上述诊断标准和纳入标准者。 2.年龄在18周岁以下,或者70周岁以上,妊娠及哺乳期妇女。 3.合并严重心、肝、肾、肺功能损害。 4.依从性差、不能配合者。 

Exclusion criteria:

1. do not meet the above diagnostic criteria and inclusion criteria. 2. at the age of 18 years of age, or 70 years of age, pregnant and lactating women. 3. combined with severe heart, liver, kidney and lung function damage. 4. poor compliance and unable to cooperate with others. 

研究实施时间:

Study execute time:

From2017-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

样本量:

300

Group:

No

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shenzhen Traditional Chinese Medicine hospital  

Level of the institution:

three A hospital 

测量指标:

Outcomes:

指标中文名:

眼底微血管特征

指标类型:

主要指标 

Outcome:

retinal vascular charateristic

Type:

Primary indicator 

指标中文名:

动态血压

指标类型:

主要指标 

Outcome:

ambulatory blood pressure

Type:

Primary indicator 

指标中文名:

中风风险因素

指标类型:

主要指标 

Outcome:

risk factors of stroke

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 18 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

No

Gender:

Both

盲法:

Blinding:

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

Resman临床试验公共管理平台(http://www.medresman.org)

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

Resman Clinical Trial Management Public Platform

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):

1. 研究数据:病例报告表,眼底检查资料,动态血压数据 2. 数据库:Excel,眼底血管检查数据、动态血压数据

The repository and management of the data(Please specify what repository will be used for management of the metadata):

1.Research Data: Case Report Form,the data of retinal vessels and ambulatory blood pressure. 2.Databsse: Excel, the data of retinal vessels and ambulatory blood pressure。

创建人:

Creater Name:

 2018-11-01
返回列表