中医综合治疗方案治疗脊柱关节炎的前瞻性队列研究

注册号:

Registration number:

ITMCTR2024000111

最近更新日期:

Date of Last Refreshed on:

2024-06-27

注册时间:

Date of Registration:

2024-06-27

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

中医综合治疗方案治疗脊柱关节炎的前瞻性队列研究

Public title:

A prospective cohort study of a TCM integrated treatment regimen for the treatment of spondyloarthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医综合治疗方案治疗脊柱关节炎的前瞻性队列研究

Scientific title:

A prospective cohort study of a TCM integrated treatment regimen for the treatment of spondyloarthritis

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:

张秦

研究负责人:

张秦

Applicant:

ZHANG QIN

Study leader:

ZHANG QIN

申请注册联系人电话:

Applicant telephone:

13366033253

研究负责人电话:

Study leader's telephone:

13366033253

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:

qinzhang1974@126.com

研究负责人电子邮件:

Study leader's E-mail:

qinzhang1974@126.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:

北京市东城区美术馆后街23号

研究负责人通讯地址:

北京市东城区美术馆后街23号

Applicant address:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

Study leader's address:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

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:

首都医科大学附属北京中医医院

Applicant's institution:

Beijing Hospital of Traditional 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:

2024BL02-005-02

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:

首都医科大学附属北京中医医院医学伦理委员会

Name of the ethic committee:

首都医科大学附属北京中医医院医学伦理委员会

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/25 0:00:00

伦理委员会联系人:

刘声

Contact Name of the ethic committee:

Liu Sheng

伦理委员会联系地址:

北京市东城区美术馆后街23号

Contact Address of the ethic committee:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-87906734

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gcpggyx@126.com

研究实施负责(组长)单位:

首都医科大学附属北京中医医院

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号

Primary sponsor's address:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

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):

朝阳区

Country:

china

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京中医医院

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine

Address:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

经费或物资来源:

2023年中央财政转移支付地方项目

Source(s) of funding:

2023年中央财政转移支付地方项目

研究疾病:

脊柱关节炎

研究疾病代码:

Target disease:

spondyloarthritis

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:

其它

Others

研究目的:

开展适宜技术方案的推广应用研究等方法,为脊柱关节炎的中医治疗,提供客观的循证证据支撑,创建脊柱关节炎的中医循证治疗基地。

Objectives of Study:

Carry out research on the promotion and application of appropriate technical solutions to provide objective evidence-based evidence support for the TCM treatment of spondyloarthritis, and create a TCM evidence-based treatment base for spondyloarthritis.

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 受试者根据分类标准诊断脊柱关节炎。 ② 受试者在筛选访视时须年满18周岁,小于60岁,性别不限。 ③ 受试者本人在知情同意书上亲笔签名并注明日期,表示其已获知研究的所有相关信息。愿意并能够遵循计划访视、治疗计划、实验室检查和其他研究程序。

Inclusion criteria

(1) Subject was diagnosed with spondyloarthritis according to classification criteria. (2) Subjects must be at least 18 years old and less than 60 years old at the time of the screening visit, regardless of gender. (3) The subject himself or herself has signed and dated the informed consent form, indicating that he or she has been informed of all relevant information about the study. Willing and able to follow scheduled visits, treatment plans, laboratory tests, and other study procedures.

排除标准:

① 精神性疾病,无自知力,无法确切表达或不能按时服药者。 ② 研究者认为不适合参加本次试验。 ③ 正在参加其他临床试验的患者。

Exclusion criteria:

(1) Mental illness, lack of self-awareness, inability to express accurately or inability to take medication on time. (2) In the opinion of the investigator, it is not suitable to participate in this trial. (3) Patients who are participating in other clinical trials.

研究实施时间:

Study execute time:

From 2024-03-01

To      2025-02-28

征募观察对象时间:

Recruiting time:

From 2024-04-01

To      2025-02-28

干预措施:

Interventions:

组别:

暴露组

样本量:

100

Group:

exposed groups

Sample size:

干预措施:

应用中药、中成药等中医综合治疗

干预措施代码:

Intervention:

The application of traditional Chinese medicine, Chinese patent medicine and other traditional Chinese medicine comprehensive treatment

Intervention code:

组别:

非暴露组

样本量:

100

Group:

non-exposed groups

Sample size:

干预措施:

未应用中医综合治疗方案

干预措施代码:

Intervention:

No TCM comprehensive treatment regimen was applied

Intervention code:

样本总量 Total sample size : 200

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):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

首都医科大学附属北京中医医院

单位级别:

三甲

Institution/hospital:

Beijing Hospital of Traditional Chinese Medicine

Level of the institution:

a Grade Ⅲ Level A hospital

国家:

中国

省(直辖市):

北京

市(区县):

延庆区

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医医院延庆医院

单位级别:

二甲

Institution/hospital:

Beijing Hospital of Traditional Chinese Medicine Yanqing Hospital

Level of the institution:

a Grade Ⅱ Level A hospital

国家:

中国

省(直辖市):

北京

市(区县):

顺义区

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医医院顺义医院

单位级别:

三甲

Institution/hospital:

Beijing Hospital of Traditional Chinese Medicine Shunyi Hospital

Level of the institution:

a Grade Ⅲ Level A hospital

国家:

中国

省(直辖市):

北京

市(区县):

怀柔区

Country:

China

Province:

Beijing

City:

Huairou District

单位(医院):

北京中医医院怀柔医院

单位级别:

三甲

Institution/hospital:

Beijing Hospital of Traditional Chinese Medicine Huairou Hospital

Level of the institution:

a Grade Ⅲ Level A hospital

测量指标:

Outcomes:

指标中文名:

ASAS 改善标准

指标类型:

主要指标

Outcome:

ASAS-IC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状体征评分

指标类型:

次要指标

Outcome:

Symptom and sign score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室检测

指标类型:

次要指标

Outcome:

Laboratory tests

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 60
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):

非随机

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

no

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):

no

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

no

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:

依托国家风湿病数据中心,使用电子版CRF表格,对所有填写了知情同意书并筛选合格进入观察的患者,均应认真、详细记录随访计划里的各项数据,切勿空项、漏填,由专人定期对随访系统中的数据行审查,确保随访数据能够在时间窗内及时提交。使用Epidata3.0建立数据库,由两名数据管理员负责对随访数据进行核查,对随访数据中存在的疑问,及时向研究者发出询问,数据管理员根据研究者的回答进行数据修改、确认,以保证数据质量,进行一致性检验后锁定数据库。

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

Relying on the National Rheumatology Data Center, using the electronic CRF form, all patients who have filled in the informed consent form and screened for qualified observation should carefully and in detail record the data in the follow-up plan, and should not fill in blank items or omissions, and the data in the follow-up system should be reviewed regularly by special personnel to ensure that the follow-up data can be submitted in a timely manner within the time window. The database was established using Epidata 3.0, and two data managers were responsible for checking the follow-up data, and asking the researchers in time for the questions in the follow-up data, and the data managers modified and confirmed the data according to the researchers' answers to ensure the quality of the data, and locked the database after consistency testing.

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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