关于经期针刺对月经影响的调查研究

注册号:

Registration number:

AMCTR-OPC-17000103 

注册号获得时间:

Date of releasing the registration number:

2017/9/18 12:24:02 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

关于经期针刺对月经影响的调查研究 

Public title:

Research about the effect of recieving acupuncture during menstrual cycles on menstruation 

研究课题的正式科学名称:

关于经期针刺对月经影响的调查研究 

Scientific title:

Research about the effect of recieving acupuncture during menstrual cycles on menstruation 

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:

张学成 

研究负责人:

张学成 

Applicant:

Zhang Xuecheng 

Study leader:

Zhang Xuecheng 

申请注册联系人电话:

Applicant telephone:

18811503995 

研究负责人电话:

Study leader's telephone:

18811503995 

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:

zhangxuechengmail@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangxuechengmail@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:

中国中医科学院广安门医院 

研究负责人通讯地址:

中国中医科学院广安门医院 

Applicant address:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

Study leader's address:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

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:

中国中医科学院广安门医院 

Applicant's institution:

Guang'anmen Hospital,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:

2017-007-KY 

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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee of Guanganmen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-03-22 

研究实施负责(组长)单位:

中国中医科学院广安门医院 

Primary sponsor:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

中国中医科学院广安门医院 

Primary sponsor's address:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

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(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences

Address:

No.5, beiji pavilion, xicheng district, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

None. 

研究疾病:

卵巢功能减退;痛经;月经不调;腰腿痛;颈椎病; 

Target disease:

hypoovarianism;dysmenorrhea;abnormal menstruation;lumbar-leg pain;cervical spondylosis 

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:

探讨经期针刺是否会给女性月经带来短期或长期的影响 

Objectives of Study:

The study aims to give a profile of the effect of recieving acupuncture treatment during menstrual cycles on menstruation ,and weather the effect is short-term or long-term. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

①一年内,曾接受针刺治疗且治疗期间至少跨越了1次月经来潮时间的女性患者; ②意识清醒,无精神障碍,无严重心、肝、肾脏疾病的患者; ③愿意接受问卷调查及电话回访的患者。 同时符合以上3项者方可纳入本研究。 

Inclusion criteria

①The female patients should have received acupuncture treatment in one year ,and have at least one menstrual cycle during therapy. ②The patient should be consciousand and have no mental disorders,and have no severe heart,liver or kidney disease ③The patients should be willing to receive questionnaire and follow-up phone calls. Those who meet all of the above three conditions could be involved in this trial. 

排除标准:

①认知障碍,不能理解量表评价内容的患者 ②已经处于绝经期的女性; ③月经尚未来潮的青少年、儿童。 ④服用了可能影响月经的药物的患者 凡符合上述任意1项者,予以排除。 

Exclusion criteria:

①Those who have cognitive Disorders, or have problems to understand the questionnaire conten. ②Those who have been postmenopausal. ③The children or adolescence who don't have menstruation. ④The patients who have had drugs that may effect menstrual cycle. Those who conform to any of the above mentioned should be excluded. 

研究实施时间:

Study execute time:

From2016-12-01To 2017-10-01 

干预措施:

Interventions:

组别:

经期针刺组

样本量:

200

Group:

group 1

Sample size:

干预措施:

经期针刺

干预措施代码:

Intervention:

acupuncture treatment during period

Intervention code:

组别:

经期不针刺组

样本量:

200

Group:

group 2

Sample size:

干预措施:

经期不针刺

干预措施代码:

Intervention:

no acupuncture treatment during period

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(区县):

西城区 

Country:

China 

Province:

Beijing 

City:

Xicheng District 

单位(医院):

中国中医科学院广安门医院 

单位级别:

三级医院 

Institution
hospital:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences  

Level of the institution:

3A hospital 

测量指标:

Outcomes:

指标中文名:

月经周期

指标类型:

主要指标 

Outcome:

the menstrual cycle

Type:

Primary indicator 

指标中文名:

经量

指标类型:

次要指标 

Outcome:

menstrual volume

Type:

Secondary indicator 

指标中文名:

经期持续时间

指标类型:

次要指标 

Outcome:

duration of menstruation

Type:

Secondary indicator 

指标中文名:

不良反应

指标类型:

次要指标 

Outcome:

adverse events

Type:

Secondary indicator 

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 12 years
最大 Max age 55 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

女性

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

none

Gender:

Female

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):

www.acmctr.org:8082

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

www.acmctr.org:8082

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):

www.acmctr.org:8082

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

www.acmctr.org:8082

创建人:

Creater Name:

 2017-09-13
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