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王舢泽医师:请重新上传伦理审批文件并填写伦理委员会联系人。 手阳明经透刺治疗桥本氏甲状腺炎的临床随机对照试验
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注册号:

Registration number:

ChiCTR1900026830 

最近更新日期:

Date of Last Refreshed on:

2019-10-23 

注册时间:

Date of Registration:

2019-10-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

王舢泽医师:请重新上传伦理审批文件并填写伦理委员会联系人。 手阳明经透刺治疗桥本氏甲状腺炎的临床随机对照试验 

Public title:

Clinical Randomized Controlled Trial for the Treatment of Hashimoto's Thyroiditis by Hand Yangming Transthoracic Acupuncture 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

手阳明经透刺治疗桥本氏甲状腺炎的临床随机对照试验 

Scientific title:

Clinical Randomized Controlled Trial for the Treatment of Hashimoto's Thyroiditis by Hand Yangming Transthoracic Acupuncture 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

AMCTR-IOR-19000308 

申请注册联系人:

王舢泽 

研究负责人:

王舢泽 

Applicant:

Shanze Wang 

Study leader:

Shanze Wang 

申请注册联系人电话:

Applicant telephone:

+86 18811300928 

研究负责人电话:

Study leader's telephone:

+86 18811300928 

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:

wangshanze2012@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangshanze2012@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:

北京市东城区海运仓胡同5号 

研究负责人通讯地址:

北京市东城区海运仓胡同5号 

Applicant address:

5 Haiyuncang, Dongcheng District, Beijing, China 

Study leader's address:

5 Haiyuncang, Dongcheng District, Beijing, 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:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital, Beijing University of Traditional 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:

DZMEC-KY-2019-33 

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:

北京中医药大学东直门医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-06 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

北京市东城区海运仓胡同5号 

Contact Address of the ethic committee:

5 Haiyuncang, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

北京市东城区海运仓胡同5号 

Primary sponsor's address:

5 Haiyuncang, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

东直门医院

具体地址:

东城区海运仓胡同5号

Institution
hospital:

Dongzhimen Hospital

Address:

5 Haiyuncang, Dongcheng District

经费或物资来源:

2019北京中医药大学基本科研业务费 

Source(s) of funding:

Fundamental Research Business Expenses of Beijing University of Traditional Chinese Medicine in 2019 

研究疾病:

桥本氏甲状腺炎 

Target disease:

Hashimoto's thyroiditis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察手阳明经透刺法治疗桥本氏甲状腺炎甲状腺功能减退症患者的临床疗效。 

Objectives of Study:

To observe the clinical effect of hand Yangming meridian penetrating needling therapy on Hashimoto's thyroiditis with hypothyroidism. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 符合桥本甲状腺炎的诊断标准者; (2) 年龄 18-70 岁者; (3) 近 1 个月查血清甲状腺激素处于正常水平,且规律服用外源性左甲状腺素治疗者; (4) 愿意配合针刺治疗并签署知情同意书者。 

Inclusion criteria

(1) Meets the diagnostic criteria for Hashimoto's thyroiditis; (2) Aged 18-70 years; (3) In the past 1 month, the serum thyroid hormone was found to be at a normal level, and the exogenous levothyroxine was regularly administered; (4) Willing to cooperate with acupuncture treatment and sign informed consent. 

排除标准:

(1) 促甲状腺激素受体抗体(TRAb)阳性,且怀疑合并graves病或桥本甲亢者; (2) 甲状腺肿大质硬伴结节,或CEUS示结节不均匀增强,高度怀疑甲状腺恶性肿瘤者; (3) 急性起病、发热等全身症状及甲状腺疼痛、肿大, ESR显著增快,甲状腺摄碘率降低,高度怀疑亚急性甲状腺炎者; (4) 曾行甲状腺手术者; (5) 近一个月接受除外源性甲状腺激素治疗外的西医治疗(如硒补充治疗),或服用含碘的中药; (6) 合并严重的心血管、脑血管、肝、肾和血液系统疾病等原发性疾病者; (7) 患有精神或心理疾病者; (8) 妊娠或哺乳期妇女; (9) 存在试验疗法的禁忌症,包括施针部位皮肤有感染或严重皮损、受试者晕针、严重惧针等。 

Exclusion criteria:

(1) Thyroid stimulating hormone receptor antibody (TRAb) positive, and suspected of combining Graves disease or Hashimoto's hyperthyroidism; (2) Highly suspected thyroid malignancy; (3) Highly suspected subacute thyroiditis; (4) Have undergone thyroid surgery; (5) Accepting western medicine treatment (such as selenium supplementation treatment) other than the treatment of exogenous thyroid hormone, or taking Chinese medicine containing iodine in the past month; (6) Have a combination of severe cardiovascular, cerebrovascular, liver, kidney, and blood system diseases; (7) Suffering from mental or mental illness; (8) Pregnancy or lactation women; (9) Have contraindications to experimental therapy, including infection or severe skin lesions on the skin at the needle site, fainting of the subject, severe fear of needles, etc.. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-06-30 

征募观察对象时间:

Recruiting time:

From2019-10-10To 2021-01-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

针刺+基础治疗

干预措施代码:

01

Intervention:

acupuncture+basic treatment

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

基础治疗

干预措施代码:

02

Intervention:

basic treatment

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

甲状腺自身抗体

指标类型:

主要指标 

Outcome:

Thyroid autoantibody

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状腺激素水平测定

指标类型:

主要指标 

Outcome:

thyroid hormone

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状腺疾病生活质量量表

指标类型:

次要指标 

Outcome:

ThyPRO

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36生活质量量表

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HAD焦虑抑郁量表

指标类型:

次要指标 

Outcome:

HAD scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表法

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

Random Number Table Method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

向研究者索取

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

Request from Researchers

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据由北京中医药大学东直门医院针灸科统一保存和管理,使用Microsoft Office Access数据库。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data will be kept at the Acupuncture Department of Dongzhimen Hospital using Microsoft Office Access.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-23
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