针药结合治疗痛风性关节炎的随机对照临床研究

注册号:

Registration number:

ITMCTR2024000218

最近更新日期:

Date of Last Refreshed on:

2024-08-12

注册时间:

Date of Registration:

2024-08-12

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针药结合治疗痛风性关节炎的随机对照临床研究

Public title:

A combination of acupuncture and drug for gouty arthritis: a randomized controlled trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针药结合治疗痛风性关节炎的随机对照临床研究

Scientific title:

A combination of acupuncture and drug for gouty arthritis: a randomized controlled trial

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:

王一然

研究负责人:

刘存志

Applicant:

Yiran,Wang

Study leader:

Cunzhi,Liu

申请注册联系人电话:

Applicant telephone:

+86 18874259558

研究负责人电话:

Study leader's telephone:

+86 10 5391 2201

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:

18874259558@163.com

研究负责人电子邮件:

Study leader's E-mail:

lcz_tg@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:

北京市朝阳区北三环东路11号

研究负责人通讯地址:

北京市朝阳区北三环东路11号

Applicant address:

11 North Third Ring Road East, Chaoyang District Beijing

Study leader's address:

11 North Third Ring Road East, 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:

北京中医药大学针灸推拿学院

Applicant's institution:

School of Acupuncture-Moxibustion and Tuina,Beijing 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:

2023BZYLL0103

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:

北京中医药大学医学伦理委员会

Name of the ethic committee:

Ethics Committee of Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/1/7 0:00:00

伦理委员会联系人:

李梅、赵丽红

Contact Name of the ethic committee:

Mei,Li; Lihong,Zhao

伦理委员会联系地址:

北京市朝阳区北三环东路11号

Contact Address of the ethic committee:

11 North Third Ring Road East, Chaoyang District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 5391 1431

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@bucm.edu.cn

研究实施负责(组长)单位:

北京中医药大学

Primary sponsor:

Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号

Primary sponsor's address:

11 North Third Ring Road East, Chaoyang 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学

具体地址:

北京市朝阳区北三环东路11号

Institution
hospital:

Beijing University of Chinese Medicine

Address:

11 North Third Ring Road East, Chaoyang District, Beijing

经费或物资来源:

国家重点研发计划中医药现代化研究重点专项(项目编号:2022YFC3500605)

Source(s) of funding:

The National Key Research and Development Program for the Modernization of Traditional Chinese Medicine(No. 2022YFC3500605)

研究疾病:

急性痛风性关节炎

研究疾病代码:

Target disease:

acute gouty arthritis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

探讨针药结合治疗急性痛风性关节炎的疗效

Objectives of Study:

To investigate the efficacy of the combination of acupuncture and drug in the treatment of acute gouty arthritis

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符合1977年美国风湿学会及2015年美国风湿病学会和欧洲抗风湿病联盟共同制定的痛风诊断标准 ②年龄在18-75岁之间,男女不限 ③急性痛风发作48小时以内 ④VAS评分≥60mm ⑤病变累及单侧第一跖趾关节或单侧踝关节

Inclusion criteria

(Ⅰ)Meets the American College of Rheumatology 1977 preliminary criteria for the classification of acute gouty arthritis and the American College of Rheumatology/European League Against Rheumatism 2015 classification criteria of gout (Ⅱ)Aged between 18 and 75 years (either sex) (Ⅲ)Patients who are suffering from acute gouty arthritis within 48 hours (Ⅳ)Pain intensity ≥60 mm on a 0–100mm visual analogue scale (VAS) (Ⅴ)Affected the unilateral first metatarsophalangeal joint or unilateral ankle joint

排除标准:

①怀疑感染性关节炎或其他关节疾病 ②研究期间计划进行剔除痛风石或关节矫正手术 ③活动性消化道溃疡/出血或既往有复发性消化道溃疡/出血病史 ④严重的急慢性器质性疾病或精神类疾病或传染性疾病 ⑤研究药物禁忌症(比如对研究药物过敏、严重的消化道溃疡、高血压等) ⑥金属过敏、凝血功能障碍、针刺部位严重皮损 ⑦备孕,妊娠期及哺乳期妇女 ⑧近3个月接受过针灸治疗 ⑨近1个月使用糖皮质激素以及24小时内使用非甾体抗炎药、秋水仙碱等具有抗炎镇痛作用的药物 ⑩同时参加其他临床研究 满足以上1项或多项要求者即予排除

Exclusion criteria:

(Ⅰ)A clinical suspicion of infectious arthritis or other joint disease (Ⅱ)Surgical intervention for gouty tophus or joint correction surgery is planned during the study (Ⅲ)Active peptic ulcer/gastrointestinal bleeding or history of peptic ulcer/gastrointestinal bleeding (Ⅳ)Severe acute or chronic organic diseases (Ⅴ)Any history contraindicating the use of drug in the trial(allergy, severe peptic ulcer, hypertension and so on) (Ⅵ)Metal allergy, blood coagulation disorders and severe skin damage at body regions of acupuncture (Ⅶ)Prepare for pregnancy or pregnancy or lactation (Ⅷ)Acupuncture treatment in the last 3 months (Ⅸ)Any history of using glucocorticoid in the last 1 month and using anti-inflammatory and analgesic drugs like nonsteroidal anti-inflammatory drugs, colchicine, etc. (Ⅹ)Participate in other clinical trials Those who meet one or more of the above requirements will be excluded.

研究实施时间:

Study execute time:

From 2024-08-18

To      2025-08-25

征募观察对象时间:

Recruiting time:

From 2024-08-25

To      2025-08-25

干预措施:

Interventions:

组别:

假针组

样本量:

80

Group:

sham acupuncture group

Sample size:

干预措施:

假针联合依托考昔

干预措施代码:

Intervention:

Patients will receive etoricoxib and sham acupuncture treatment.

Intervention code:

组别:

针刺组

样本量:

80

Group:

acupuncture group

Sample size:

干预措施:

针刺联合依托考昔

干预措施代码:

Intervention:

Patients will receive etoricoxib and acupuncture treatment.

Intervention code:

样本总量 Total sample size : 160

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

福建省

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

厦门大学附属第一医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Xiamen University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江中医药大学第三附属医院

单位级别:

三级甲等

Institution/hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

连云港市中医院

单位级别:

三级甲等

Institution/hospital:

Lianyungang Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市房山区良乡医院

单位级别:

三级

Institution/hospital:

Liangxiang Hospital, Fangshan District, Beijing

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

福建省

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

厦门市中医院

单位级别:

三级甲等

Institution/hospital:

Xiamen Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

关节压痛评分

指标类型:

次要指标

Outcome:

Tenderness of study joint

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

盲法评价

指标类型:

附加指标

Outcome:

Blinding assessment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

可信度及期望评价

指标类型:

附加指标

Outcome:

Credibility and expectation evaluation

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急救用药使用情况

指标类型:

次要指标

Outcome:

The use of rescue medicine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束即刻疼痛程度较基线的变化值

指标类型:

主要指标

Outcome:

change from baseline in pain intensity immediately after the end of treatment

Type:

Primary indicator

测量时间点:

治疗结束后即刻

测量方法:

Measure time point of outcome:

immediately after the end of treatment

Measure method:

指标中文名:

关节肿胀评分

指标类型:

次要指标

Outcome:

Swelling of study joint

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

其他时间点疼痛程度较基线的变化值

指标类型:

次要指标

Outcome:

change from baseline in pain intensity at other time points

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标

Outcome:

Adverse event

Type:

Adverse events

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:

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 75
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):

由统计人员采用中心分层动态区组随机方法通过统计学软件生成随机序列

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

The randomization sequence was generated by the statistician using the central stratified dynamic block randomization method with statistical software.

盲法:

对受试者、结局评价者和数据统计分析者设盲

Blinding:

Participants, outcome assessors, and statistical analysts were blinded.

是否共享原始数据:

IPD sharing:

Yes

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):

试验完成后6个月内,通过中国临床试验注册中心的ResMan平台进行原始数据的共享(http:/www.medresman.org.cn.)

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

Within 6 months after the trial complete, we will share lPD based on the ResMan platform (htp:/www.medresman.org.cn.)

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:

通过电子采集和管理系统记录数据(Electronic Data Capture, EDC)

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

The records of metadata are recorded through Electronic Data Capture.

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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