疏肝抑亢系列方干预Graves甲亢的真实世界队列研究

注册号:

Registration number:

ITMCTR2024000726

最近更新日期:

Date of Last Refreshed on:

2024-11-22

注册时间:

Date of Registration:

2024-11-22

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

疏肝抑亢系列方干预Graves甲亢的真实世界队列研究

Public title:

A Real-World Cohort Study on the Effect of Shuxian Yikang Series Formulae in Treating Graves' Hyperthyroidism

注册题目简写:

English Acronym:

研究课题的正式科学名称:

疏肝抑亢系列方干预Graves甲亢的真实世界队列研究

Scientific title:

A Real-World Cohort Study on the Effect of Shuxian Yikang Series Formulae in Treating Graves' Hyperthyroidism

研究课题的正式科学名称简写:

Scientific title acronym:

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:

申请注册联系人:

李羲子

研究负责人:

余江毅

Applicant:

Li Xizi

Study leader:

Yu Jiangyi

申请注册联系人电话:

Applicant telephone:

18355847081

研究负责人电话:

Study leader's telephone:

13951704703

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:

lxizi2023@163.com

研究负责人电子邮件:

Study leader's E-mail:

yujiangyi2007@163.com

申请单位网址(自愿提供):

Study leader's 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:

江苏省南京市鼓楼区南京中医药大学汉中门校区

研究负责人通讯地址:

江苏省南京市秦淮区江苏省中医院

Applicant address:

Hanzhongmen Campus Nanjing University of Chinese Medicine Gulou District Nanjing City Jiangsu Province

Study leader's address:

Jiangsu Provincial Hospital of Traditional Chinese Medicine Qinhuai District Nanjing City Jiangsu Province

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:

南京中医药大学附属医院

Applicant's institution:

Affiliated Hospital of Nanjing University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024NL-258-02

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

南京中医药大学附属医院(江苏省中医院)伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Hospital of Traditional Chinese Medicine)

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/14 0:00:00

伦理委员会联系人:

王卯

Contact Name of the ethic committee:

Wang Mao

伦理委员会联系地址:

江苏省南京市秦淮区江苏省中医院

Contact Address of the ethic committee:

Jiangsu Provincial Hospital of Traditional Chinese Medicine Qinhuai District Nanjing City Jiangsu Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

025-86560515

伦理委员会联系人邮箱:

Contact email of the ethic committee:

706836730@qq.com

研究实施负责(组长)单位:

江苏省中医院

Primary sponsor:

Jiangsu Provincial Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号

Primary sponsor's address:

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu 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):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu Province

City:

Nanjing City

单位(医院):

江苏省中医院

具体地址:

江苏省南京市秦淮区汉中路155号

Institution
hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address:

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

经费或物资来源:

Source(s) of funding:

No

研究疾病:

甲状腺功能亢进症

研究疾病代码:

Target disease:

Graves' diease

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

基于真实世界的前瞻性队列研究,评价疏肝抑亢系列方治疗Graves 甲亢的有效性与安全性,提供疏肝抑亢系列方治疗Graves 甲亢的临床证据;进一步寻求Graves 甲亢诊疗中以疏肝抑亢系列方为主的用药方案的具体适应症,丰富Graves 甲亢精确诊疗方案,为后续进一步临床研究提供研究基础。

Objectives of Study:

Based on the real world prospective cohort study to evaluate the efficacy and safety of Shugan Yikang series of prescriptions in the treatment of Graves' hyperthyroidism and to provide clinical evidence of Shugan Yikang series of prescriptions in the treatment of Graves' hyperthyroidism. The specific indications of the drug regimen based on the soothing liver-Yekang series of prescriptions in the diagnosis and treatment of Graves' hyperthyroidism should be further explored so as to enrich the precise diagnosis and treatment regimen for Graves' hyperthyroidism and provide the research basis for further clinical studies.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)性别不限,年龄 18-70 周岁的 Graves 甲亢患者(初发、停药后复发); (2)辨证证属肝火旺盛证者; (3)自愿签署知情同意书。

Inclusion criteria

(1) Patients with Graves hyperthyroidism aged 18-70 years of age regardless of gender (initial onset relapse after drug withdrawal); (2) The syndrome of liver fire exuberant; (3) Voluntary signing of informed consent.

排除标准:

(1)有妊娠计划、妊娠或哺乳期的患者 (2)有严重的心、肝、肾、脑病及精神病患者,如谷草转氨酶(AST)和/或谷丙转氨酶 (ALT)升高超过参考范围(AST>138U/L,ALT>210U/L)≥3 倍、中性粒细胞计数绝 对值(N)<1.5*10 9 /L 等。 (3)甲亢危象患者; (4)各种甲状腺炎; (5)过敏体质及对本试验药物过敏者; (6)使用其他富碘药物者,例如胺碘酮等

Exclusion criteria:

(1) Patients with pregnancy plans pregnancy or lactation (2) Patients with severe heart liver kidney brain diseases and psychosis such as aspartate aminotransferase (AST) and/or Alt (ALT) elevation beyond the reference range (AST > 138U/L ALT > 210U/L) ≥3 times neutrophil count is zero Value (N) < 1.5*10 9 /L etc. (3) hyperthyroidism crisis patients; (4) various thyroiditis; (5) Allergic constitution and allergic to the test drug; (6) Use of other iodine-rich drugs such as amiodarone

研究实施时间:

Study execute time:

From 2024-11-25

To      2029-10-31

征募观察对象时间:

Recruiting time:

From 2024-11-25

To      2029-10-31

干预措施:

Interventions:

组别:

非暴露组

样本量:

1800

Group:

Non-exposed group

Sample size:

干预措施:

未使用疏肝抑亢系列方

干预措施代码:

Intervention:

No use of the series of herbal formulas for liver detoxification and hyperactivity suppression.

Intervention code:

组别:

疏肝抑亢系列方组

样本量:

600

Group:

Soothing liver Yikang series prescription group

Sample size:

干预措施:

使用疏肝抑亢系列方

干预措施代码:

Intervention:

Use the Shugan Yikang series formula

Intervention code:

样本总量 Total sample size : 2400

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu Province

City:

Nanjing City

单位(医院):

江苏省中医院

单位级别:

江苏省南京市秦淮区汉中路155号

Institution/hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

测量指标:

Outcomes:

指标中文名:

促甲状腺激素

指标类型:

主要指标

Outcome:

tsh

Type:

Primary indicator

测量时间点:

每月一次

测量方法:

依托江苏中医院检验科检测

Measure time point of outcome:

Once a month

Measure method:

Relying on the inspection department of Jiangsu Hospital of Traditional Chinese Medicine

指标中文名:

游离三碘甲腺原氨酸

指标类型:

主要指标

Outcome:

ft3

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲巯咪唑减药量

指标类型:

次要指标

Outcome:

Reduction of methimazole

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候积分量化评分

指标类型:

次要指标

Outcome:

TCM symptom score quantified

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

Blood routine examination

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状腺大小、结节变化

指标类型:

次要指标

Outcome:

Thyroid size nodules change

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促甲状腺素受体抗体

指标类型:

次要指标

Outcome:

trab

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

停药后复发率

指标类型:

次要指标

Outcome:

Relapse rate after discontinuation

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

突眼缓解率

指标类型:

次要指标

Outcome:

Exophthalmic remission rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总甲状腺素

指标类型:

主要指标

Outcome:

tt4

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

副作用指标

Outcome:

renal function

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

游离甲状腺素

指标类型:

主要指标

Outcome:

ft4

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗甲状腺过氧化物酶抗体

指标类型:

次要指标

Outcome:

tpoab

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标

Outcome:

Liver function

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿碘测定

指标类型:

次要指标

Outcome:

Urine iodimetry

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗甲状腺球蛋白抗体

指标类型:

次要指标

Outcome:

tgab

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总三碘甲腺原氨酸

指标类型:

主要指标

Outcome:

tt3

Type:

Primary 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:

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用真实世界研究不涉及随机方法

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

Using real world research does not involve random methods

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

Resman

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

Resman

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:

病例记录表/电子病例记录表

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

CRF/eCRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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