针灸治疗慢性荨麻疹的病例注册登记研究

注册号:

Registration number:

AMCTR-OOC-19000249 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 19:07:12 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针灸治疗慢性荨麻疹的病例注册登记研究 

Public title:

Acupuncture for chronic urticaria: a patient registry study 

研究课题的正式科学名称:

针灸治疗慢性荨麻疹疗效评价研究(2017YFC1703605) 

Scientific title:

Acupuncture treatment of chronic urticaria curative effect evaluation research(2017YFC1703605) 

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:

王艳君 

研究负责人:

王艳君 

Applicant:

Wang Yanjun 

Study leader:

Wang Yanjun 

申请注册联系人电话:

Applicant telephone:

13933016908 

研究负责人电话:

Study leader's telephone:

13933016908 

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:

wangyj8055@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

wangyj8055@sina.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:

wangyj8055@sina.com 

研究负责人通讯地址:

wangyj8055@sina.com 

Applicant address:

wangyj8055@sina.com 

Study leader's address:

wangyj8055@sina.com 

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:

河北省中医院 

Applicant's institution:

Hebei Province Hospital 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:

2018-科研-023 

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:

河北省中医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Hebei Province Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-26 

研究实施负责(组长)单位:

河北省中医院 

Primary sponsor:

Hebei Province Hospital of Chinese Medicine 

研究实施负责(组长)单位地址:

河北省石家庄市长安区中山东路389号 

Primary sponsor's address:

389 Zhongshan East Road, Changan District, Shijiazhuang City, Hebei Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北省

市(区县):

石家庄

Country:

China

Province:

Hebei

City:

Shi

单位(医院):

河北省中医院

具体地址:

河北省石家庄市长安区中山东路389号

Institution
hospital:

Hebei Province Hospital of Chinese Medicine

Address:

389 Zhongshan East Road, Changan District, Shijiazhuang City, Hebei Province

经费或物资来源:

针灸治疗慢性荨麻疹疗效评价研究课题编号:2017YFC1703605 

Source(s) of funding:

Acupuncture Treatment of Chronic Urticaria Evaluation Evaluation Question Number:2017YFC1703605 

研究疾病:

慢性荨麻疹 

Target disease:

chronic urticaria 

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:

其它 

Study phase:

Other 

研究目的:

1、通过基于网络平台的病例注册登记研究,系统分析真实世界中影响针刺治疗慢性荨麻疹临床疗效的关键因素; 2、分析针刺治疗慢性荨麻疹的适宜病种以及人群,挖掘治疗慢性荨麻疹的针刺优效疗法。 

Objectives of Study:

1.To analyze the key factors influencing the therapeutic effects of acupuncture for chronic urticaria through patient registry platform; 2.To analyze the suitable diseases and patients of acupuncture for chronic urticaria, and find the optimal efficiency. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.符合慢性荨麻疹诊断标准; 2.未参加其它正在进行的临床研究者; 3.患者本人签署或由其直系亲属代签知情同意书,自愿参加本项研究者。 

Inclusion criteria

1. Meet the diagnostic criteria for chronic urticaria; 2. Not participating in other ongoing clinical researchers; 3. The patient himself signed or signed an informed consent by his immediate family and volunteered to participate in the researcher. 

排除标准:

1.意识不清、不能表达主观不适症状者及精神病患者; 2.进展性恶性肿瘤或其它严重消耗性疾病,易合并感染及出血者; 3.合并心血管、肝、肾、消化、造血系统等严重原发性疾病者; 4.年龄<3岁。 

Exclusion criteria:

1. People with unclear consciousness and unable to express subjective symptoms of discomfort and patients with mental illness; 2. Progression of malignant neoplasms or other severe expendable diseases, easy to combine infection and bleeding; 3. The combination of cardiovascular, liver, kidney, digestion, hematopoietic system and other serious primary diseases; 4. Age < 3 years old 

研究实施时间:

Study execute time:

From2019-01-28To 2021-12-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

50

Group:

Acupuncture group

Sample size:

干预措施:

针刺治疗

干预措施代码:

Intervention:

Acupuncture therapy

Intervention code:

组别:

拔罐组

样本量:

50

Group:

Cupping group

Sample size:

干预措施:

拔罐治疗

干预措施代码:

Intervention:

Cupping therapy

Intervention code:

组别:

艾灸组

样本量:

50

Group:

Moxibustion group

Sample size:

干预措施:

艾灸治疗

干预措施代码:

Intervention:

Moxibustion therapy

Intervention code:

组别:

穴位注射组

样本量:

50

Group:

Point injection group

Sample size:

干预措施:

穴位注射治疗

干预措施代码:

Intervention:

Point injection therapy

Intervention code:

组别:

穴位埋线组

样本量:

50

Group:

Acupoint embedding line group

Sample size:

干预措施:

穴位埋线治疗

干预措施代码:

Intervention:

Acupoint embedding line therapy

Intervention code:

组别:

耳穴组

样本量:

50

Group:

Auricular point group

Sample size:

干预措施:

耳穴治疗

干预措施代码:

Intervention:

Auricular point therapy

Intervention code:

组别:

自血组

样本量:

50

Group:

Since the blood group

Sample size:

干预措施:

自穴疗法

干预措施代码:

Intervention:

Since the blood therapy

Intervention code:

组别:

皮肤针叩刺组

样本量:

50

Group:

Dermal needle stab knocking group

Sample size:

干预措施:

皮肤针叩刺治疗

干预措施代码:

Intervention:

Dermal needle stab knocking therapy

Intervention code:

组别:

三棱针放血组

样本量:

50

Group:

Triangular needle bleeding group

Sample size:

干预措施:

三棱针放血治疗

干预措施代码:

Intervention:

Triangular needle bleeding therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

河北省 

Country:

Hebei province 

Province:

 

City:

 

单位(医院):

河北省中医院 

单位级别:

Hebei Province Hospital of Chinese Medicine 

Institution
hospital:

三级甲等  

Level of the institution:

Grade III, class A hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei province 

City:

 

单位(医院):

石家庄市中医院 

单位级别:

三级甲等 

Institution
hospital:

Shijiazhuang Traditional Chinese Medicine hospital  

Level of the institution:

Grade III, class A hospital 

国家:

中国 

省(直辖市):

山东省 

市(区县):

 

Country:

China 

Province:

Shandong province 

City:

 

单位(医院):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Shandong University of TCM  

Level of the institution:

Grade III, class A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院针灸医院 

单位级别:

一级甲等 

Institution
hospital:

Acupuncture-Moxibustion Hospital of CACMS  

Level of the institution:

Grade I, class A hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei province 

City:

 

单位(医院):

河北省沧州中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Cangzhou hospital of integrated TCM-WM·Hebei  

Level of the institution:

Grade III, class A hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei province 

City:

 

单位(医院):

唐山中医医院 

单位级别:

三级甲等 

Institution
hospital:

Tangshan Traditional Chinese Medicine hospital  

Level of the institution:

Grade III, class A hospital 

测量指标:

Outcomes:

指标中文名:

荨麻疹活动性评分

指标类型:

主要指标 

Outcome:

urticaria activity score

Type:

Primary indicator 

指标中文名:

瘙痒视觉模拟评分

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

指标中文名:

皮肤生活质量指数问卷

指标类型:

主要指标 

Outcome:

Dermatology Life Quality Index

Type:

Primary indicator 

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator 

指标中文名:

汉密尔顿焦虑量表

指标类型:

次要指标 

Outcome:

Hamilton Anxiety Scale

Type:

Secondary indicator 

指标中文名:

匹兹堡睡眠质量指数

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:

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 3 years
最大 Max age 80 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):

None

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):

试验结束后六个月在ResMan进行数据的共享

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

The data will be shared at ResMan within six months after the trial completed.

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):

数据通过国际针灸病例注册登记平台进行收集和保存,网址http://www.amreg.org/.

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

All the data will be managed through the International acupuncture and moxibustion patient registry platform. This is the URL, http://www.amreg.org/.

创建人:

Creater Name:

 2019-01-24
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