芒针“秩边透水道”针法治疗原发性痛经的随机对照研究

注册号:

Registration number:

AMCTR-IOR-17000101 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 15:15:44 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

芒针“秩边透水道”针法治疗原发性痛经的随机对照研究 

Public title:

penetrating method form Zhibian (BL54) to Shuidao (St28) with long needle for primary dysmenorhea: a randomized controlled trial 

研究课题的正式科学名称:

芒针“秩边透水道”针法治疗原发性痛经的随机对照研究 

Scientific title:

penetrating method form Zhibian (BL54) to Shuidao (St28) with long needle for primary dysmenorhea: a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR-IOR-17012621 

申请注册联系人:

王海军 

研究负责人:

冀来喜 

Applicant:

Haijun Wang 

Study leader:

Laixi Ji 

申请注册联系人电话:

Applicant telephone:

+86 15803409395 

研究负责人电话:

Study leader's telephone:

+86 13509714277 

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:

whjdavid@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tyjilaixi@126.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:

山西省高校园区大学街121号 

研究负责人通讯地址:

山西省高校园区大学街121号 

Applicant address:

121 Daxue street, Higher Educaiton Area, Shanxi, China 

Study leader's address:

Shanxi University of Chinese Medicine 

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:

山西中医药大学 

Applicant's institution:

Shanxi University of 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:

2013A-028 

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:

山西中医学院第三中医院医学伦理委员会 

Name of the ethic committee:

Ethics Review Committee of the 3rd hospital of Shanxi university of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-12-12 

研究实施负责(组长)单位:

山西中医药大学 

Primary sponsor:

Shanxi University of Chinese Medicine 

研究实施负责(组长)单位地址:

山西省高校园区大学街121号 

Primary sponsor's address:

Shanxi University of Chinese Medicine 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山西省

市(区县):

太原市

Country:

China

Province:

Shanxi

City:

Taiyuan City

单位(医院):

121 Daxue street, Higher Educaiton Area, Shanxi, China

具体地址:

山西省高校园区大学街121号

Institution
hospital:

山西中医药大学

Address:

Shanxi University of Chinese Medicine

经费或物资来源:

自筹经费 

Source(s) of funding:

self-raised fund 

研究疾病:

原发性痛经 

Target disease:

Primary Dysmenorrhea 

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:

本研究旨在研究芒针“秩边透水道”针法治疗原发性痛经的有效性及安全性,并为其治疗原发性痛经推广应用提供客观依据 

Objectives of Study:

this trial aims to investigate the efficacy and safety of penetrating method form Zhibian (BL54) to Shuidao (St28) with long needle for primary dysmenorrhea,and then to provide objective evidence for popularization treatment for primary dysmenorrhea 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.患者年龄在18-35岁未育女性 2.至少三个月经周期月经基本正常(28±7)天 3.符合《原发性痛经诊疗共识指南》诊断标准 4.视觉模拟评分法>40mm 5.签署知情同意书者。 

Inclusion criteria

1. Aged from 18 to 35 years without history of delivery; 2. Normal menstrual cycle (28+/-7 days) during the last 3 months; 3. Diagnosed with PD according to the Primary Dysmenorrhea Consensus Guidelines; 4. Menstrual pain scored > 40 mm on the Visual Analog Scale (VAS); 5. Agree with all procedures in this trial by signing a written informed consent. 

排除标准:

1.患者经妇科及B超检查由器质性病变导致的继发性痛经者 2.合并严重并发症诸如进行性心脑血管疾病、艾滋病、严重感染、精神病、恶性高血压、造血系统疾病、肝肾功能不全等 3.合并有消化道溃疡者 4.在本研究治疗前15天没有进行过其它痛经的治疗方法 5.有对阿司匹林药物过敏史者 

Exclusion criteria:

1. Secondary dysmenorrhea caused by gynecological problems confirmed by Obstetrician visit or gynecological abdominal ultrasound B examination; 2. Serious contraindications such as progressive central nervous disorder, AID, spsychiatric disorders, malignant hypertension, hematological diseases, hepatic insufficiency; 3. Having the disease of peptic ulcer; 4. Receiving or having received any other treatment for PD in the previous15days; 5. Having the allergic history to aspirin. 

研究实施时间:

Study execute time:

From2014-01-01To 2016-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

60

Group:

treatment group

Sample size:

干预措施:

秩边透水道针法

干预措施代码:

Intervention:

penetrating method form Zhibian (BL54) to Shuidao (St28)

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

布洛芬缓释胶囊

干预措施代码:

Intervention:

ibuprofen capsules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西省 

市(区县):

太原市 

Country:

China 

Province:

Shanxi 

City:

Taiyuan City 

单位(医院):

山西医学院第三中医院 

单位级别:

三级甲等 

Institution
hospital:

the third hospital of Shanxi University of Chinese Medicine  

Level of the institution:

tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分

指标类型:

主要指标 

Outcome:

视觉模拟评分

Type:

Primary indicator 

指标中文名:

COX痛经症状评分量

指标类型:

主要指标 

Outcome:

Cox Menstrual Symptom Scale

Type:

Primary indicator 

指标中文名:

血液流变学

指标类型:

次要指标 

Outcome:

Hemorheology

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血浆

组织:

Sample Name:

blood plasma

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 35 years

随机方法(请说明由何人用什么方法产生随机序列):

由专门的第三方统计者借助Spss18.0软件进行随机分组

性别:

女性

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

the patients were randomly divided into two groups (treatment group and control group) by special man

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:

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):

通过网络平台(中国临床试验注册中心,www.chictr.org.cn)

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

www.chictr.org.cn

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):

采用病例记录表(Case Record Form, CRF)

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

Case Record Form, CRF

创建人:

Creater Name:

 2017-09-09
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