背部特色推拿干预原发性失眠临床研究

注册号:

Registration number:

AMCTR-IOR-19000305 

注册号获得时间:

Date of releasing the registration number:

2019/10/23 21:39:30 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

背部特色推拿干预原发性失眠临床研究 

Public title:

Clinical study for dorsal characteristic tuina in the treatment of primary insomnia 

研究课题的正式科学名称:

背部特色推拿干预原发性失眠临床研究 

Scientific title:

Clinical study for dorsal characteristic tuina in the treatment of primary insomnia 

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:

顾非 

研究负责人:

顾非 

Applicant:

Gu Fei 

Study leader:

Gu Fei 

申请注册联系人电话:

Applicant telephone:

+86 18930568537 

研究负责人电话:

Study leader's telephone:

+86 18930568537 

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:

gufeiking@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gufeiking@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:

上海市虹口区甘河路110号 

研究负责人通讯地址:

上海市虹口区甘河路110号 

Applicant address:

110 Ganhe Road, Hongkou District, Shanghai, China 

Study leader's address:

110 Ganhe Road, Hongkou District, Shanghai, 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:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, Shanghai, 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(区县):

虹口区

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai Shen Kang Hospital Development Center 

研究疾病:

原发性失眠 

Target disease:

Primary insomnia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

研究背部特色推拿干预原发性失眠临床疗效及治疗对失眠症患者多导睡眠图改变的影响 

Objectives of Study:

To study the effect of back characteristic massage on the clinical efficacy of primary insomnia and the effect of treatment on polysomnogram changes in patients with insomnia 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

① 符合《中国精神疾病分类与诊断标准》(CCMD-3)原发性失眠诊断标准者; ② 未经过任何治疗,或经过治疗但已过一周的洗脱期; ③ 年龄在18-60岁; ④ 同意并签署知情同意书者 

Inclusion criteria

1. Meet the diagnostic criteria for primary insomnia in the Chinese Mental Disorders Classification and Diagnostic Criteria (CCMD-3); 2. A period of washout that has not been treated or treated for a week; 3. Aged 18-60 years old; 4. Agree and sign the informed consent form. 

排除标准:

①精神类疾病或者继发疾病导致失眠的患者; ②合并有心血管、肝、肾和造血系统等严重原发性疾病及精神病; ③疗程中妊娠的患者,或者产生其他 ; ④皮肤感染或损坏,不宜进行手法治疗的患者; ⑤凡不符合纳入标准,资料不全影响疗效评定者。 

Exclusion criteria:

1. Psychiatric or secondary disease causes insomnia; 2. combined with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system and mental illness; 3. patients who are pregnant during the course of treatment, or produce other; 4. patients with skin infection or damage, which is not suitable for manual treatment; 5. Those who do not meet the inclusion criteria, the data does not affect the efficacy of the assessment. 

研究实施时间:

Study execute time:

From2019-11-30To 2022-11-30 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

背部特色推拿

干预措施代码:

Intervention:

dorsal characteristic tuina

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

药物治疗

干预措施代码:

Intervention:

Conventional medicine treatment

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(区县):

虹口区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

多导睡眠图

指标类型:

主要指标 

Outcome:

polysomnography

Type:

Primary indicator 

指标中文名:

匹兹堡睡眠质量指数问卷

指标类型:

次要指标 

Outcome:

Pittsburgh sleep quality index

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

随机方法(请说明由何人用什么方法产生随机序列):

项目负责人通过SPSS 21.0生成随机数字表,每组患者30例

性别:

男性

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

The project leader generated a random number table through SPSS 21.0, with 30 patients in each group

Gender:

Male

盲法:

未说明

Blinding:

Not stated

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:

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):

依托学校及医院科研平台进行共享

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

Sharing scientific research based on platform of schools and hospitals

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):

数据通过手写记录及电子保存、整理、归纳,并按时填写患者病例报告表

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

Data by hand written records and electronic storage, sorting, induction, and on time to fill in patients with case report

创建人:

Creater Name:

 2019-10-21
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