基于病理组织多组学研究探讨高频超声评价四妙散加减方治疗痛风关节炎疗效的应用价值

注册号:

Registration number:

ITMCTR2200005890

最近更新日期:

Date of Last Refreshed on:

2022-04-20

注册时间:

Date of Registration:

2022-04-20

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于病理组织多组学研究探讨高频超声评价四妙散加减方治疗痛风关节炎疗效的应用价值

Public title:

To explore the application value of high frequency ultrasound in evaluating the effect of Simiao powder in the treatment of gouty arthritis based on the study of histopathology and multi-omics

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于病理组织多组学研究探讨高频超声评价四妙散加减方治疗痛风关节炎疗效的应用价值

Scientific title:

To explore the application value of high frequency ultrasound in evaluating the effect of Simiao powder in the treatment of gouty arthritis based on the study of histopathology and multi-omics

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:

ChiCTR2200058955 ; ChiMCTR2200005890

申请注册联系人:

赵小琪

研究负责人:

郭玲

Applicant:

Zhao xiaoqi

Study leader:

GUO Ling

申请注册联系人电话:

Applicant telephone:

15710053980

研究负责人电话:

Study leader's telephone:

13671031526

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:

809970112@qq.com

研究负责人电子邮件:

Study leader's E-mail:

guoling0726@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:

北京市朝阳区望京中环南路6号

研究负责人通讯地址:

北京市朝阳区望京中环南路6号

Applicant address:

No. 6, Wangjing Zhonghuan South Road, Chaoyang District, Beijing

Study leader's address:

No. 6, Wangjing Zhonghuan South Road, Chaoyang 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:

中国中医科学院望京医院

Applicant's institution:

Wangjing Hospital of China Academy of Chinese Medical Sciences

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:

WJEC-KT-2021-060-P002

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:

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Wangjing Hospital, Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2022/3/4 0:00:00

伦理委员会联系人:

王浩

Contact Name of the ethic committee:

Wanghao

伦理委员会联系地址:

北京市朝阳区花家地街中国中医科学院望京医院

Contact Address of the ethic committee:

Wangjing Hospital, China Academy of Chinese Medical Sciences, Huajiadi Street, Chaoyang District, Beijing

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:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市西城区广安门内北线阁5号

Primary sponsor's address:

No. 5, Inner North Line Pavilion, Guang'anmen, Xicheng 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):

Country:

china

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区望京中环南路6号

Institution
hospital:

Wangjing Hospital of China Academy of Chinese Medical Sciences

Address:

No. 6, Wangjing Zhonghuan South Road, Chaoyang District, Beijing

经费或物资来源:

课题经费

Source(s) of funding:

Project funding

研究疾病:

湿热蕴结证痛风性膝关节炎

研究疾病代码:

Target disease:

damp heat accumulation type gouty arthritis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

单臂

Single arm

研究所处阶段:

Study phase:

其它

Others

研究目的:

结合高频超声影像学、病理组织学、多组学技术,探究湿热蕴结证痛风性关节炎发病机制及高频超声评价四妙散加减方疗效的价值,以完善其疗效评价体系。

Objectives of Study:

Combined with high-frequency ultrasound imaging, histopathology, and multi-omics techniques, to explore the pathogenesis of damp heat accumulation type gouty arthritis and the value of high-frequency ultrasound to evaluate the efficacy of Simiao powder, so as to improve its efficacy evaluation system.

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)疾病诊断符合2015年ACR/EULAR痛风分类标准; 2)首诊时为痛风急性期(本次发作时间<7天),以膝关节肿痛为主要关节症状; 3)超声检查可见明确膝关节积液、滑膜、“双轨征”或晶体沉积或痛风石表现者; 4)符合湿热蕴结证中医证候诊断标准; 5)年龄在20-60岁之间。 6)自愿参加试验,并签署知情同意书。

Inclusion criteria

1) The disease diagnosis meets the 2015 ACR/EULAR gout classification criteria; 2) The first visit was in the acute stage of gout (the attack time was less than 7 days), with knee joint swelling and pain as the main joint symptom; 3) Ultrasound examination showed clear knee joint effusion, synovial membrane, "double track sign" or crystal deposition or tophi; 4) Meet the diagnostic criteria of TCM syndromes of damp-heat accumulation syndrome; 5) Age between 20-60 years old. 6) Voluntarily participate in the trial and sign the informed consent.

排除标准:

1)由某些药物(如质子泵抑制剂、小剂量阿司匹林等)、肿瘤放化疗等引起或继发于肾病、血液病、黄嘌呤尿道沉积等疾病的痛风患者; 2)首诊时为痛风非急性期; 3)合并有骨关节病、类风湿关节炎等其他风湿类疾病; 4)伴有其他膝关节疾病者:如膝关节化脓性关节炎、膝关节创伤性关节炎等; 5)合并急性加重的或控制不佳的高血压、冠心病、肝肾功能不全等慢性疾病; 6)精神性疾病,无自制力,无法确切表达或不能配合治疗者。 7)凝血功能异常者。

Exclusion criteria:

1) Patients with gout caused by certain drugs (such as proton pump inhibitors, low-dose aspirin, etc.), tumor radiotherapy and chemotherapy, etc. or secondary to diseases such as kidney disease, blood disease, and xanthine urethral deposition; 2) The first diagnosis is in the non-acute stage of gout; 3) Combined with other rheumatic diseases such as osteoarthritis and rheumatoid arthritis; 4) Those with other knee joint diseases: such as knee joint septic arthritis, knee joint traumatic arthritis, etc.; 5) Acute exacerbated or poorly controlled chronic diseases such as hypertension, coronary heart disease, liver and kidney insufficiency; 6) Mental illness, lack of self-control, unable to express accurately or unable to cooperate with treatment. 7) Those with abnormal coagulation function.

研究实施时间:

Study execute time:

From 2021-10-01

To      2024-10-01

征募观察对象时间:

Recruiting time:

From 2022-04-20

To      2024-10-01

干预措施:

Interventions:

组别:

病例组

样本量:

30

Group:

case group

Sample size:

干预措施:

四妙散加减方治疗

干预措施代码:

Intervention:

Simiao powder Treatment

Intervention code:

样本总量 Total sample size : 30

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):

中国中医科学院望京医院

单位级别:

三甲

Institution/hospital:

Wangjing Hospital of China Academy of Chinese Medical Sciences

Level of the institution:

Grade 3, Class A

测量指标:

Outcomes:

指标中文名:

超声指标

指标类型:

次要指标

Outcome:

Ultrasonic indicators

Type:

Secondary indicator

测量时间点:

用药前、用药7天、用药14天

测量方法:

超声检查

Measure time point of outcome:

Before medication, 7 days, 14 days

Measure method:

ultrasound

指标中文名:

生化指标

指标类型:

主要指标

Outcome:

Biochemical Indicators

Type:

Primary indicator

测量时间点:

用药前、用药7天、用药14天

测量方法:

抽血

Measure time point of outcome:

Before medication, 7 days, 14 days

Measure method:

blood

指标中文名:

临床症状指标

指标类型:

次要指标

Outcome:

6/5000 Clinical symptom index

Type:

Secondary indicator

测量时间点:

用药前、用药7天、用药14天

测量方法:

问诊

Measure time point of outcome:

Before medication, 7 days, 14 days

Measure method:

Physician visits

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

滑膜组织

组织:

膝关节

Sample Name:

synovial tissue

Tissue:

The knee joint

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 20
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):

按顺序

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

in the order

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):

文章发表见刊后可向注册联系人邮件申请

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

After the article is published in the journal, you can apply to the registered contact by email

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:

纸质版及电子版病例记录表

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

Paper and electronic case record forms

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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