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针刺法治疗泌尿系结石急性肾绞痛的有效性及安全性研究
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注册号:

Registration number:

ChiCTR1900025202 

最近更新日期:

Date of Last Refreshed on:

2019-08-16 

注册时间:

Date of Registration:

2019-08-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针刺法治疗泌尿系结石急性肾绞痛的有效性及安全性研究 

Public title:

Efficacy and safety of acupuncture for acute renal colic caused by urinary calculi: a randomized controlled trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针刺法治疗泌尿系结石急性肾绞痛的有效性及安全性研究 

Scientific title:

Efficacy and safety of acupuncture for acute renal colic caused by urinary calculi: a randomized controlled trial. 

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:

曹迎 

研究负责人:

曲志成 

Applicant:

Ying Cao 

Study leader:

Zhicheng Qu 

申请注册联系人电话:

Applicant telephone:

+86 13811127853 

研究负责人电话:

Study leader's telephone:

+86 15811580924 

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:

caoying7c@163.com 

研究负责人电子邮件:

Study leader's E-mail:

qzhch0824@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:

中国北京市东城区美术馆后街23号 

研究负责人通讯地址:

中国北京市东城区美术馆后街23号 

Applicant address:

23 Art Gallery Backstreet, Dongcheng District, Beijing, China 

Study leader's address:

23 Art Gallery Backstreet, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100010 

研究负责人邮政编码:

Study leader's postcode:

100010 

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 Affiliated to Capital Medical University 

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:

2019BL02-025-01 

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:

首都医科大学附属北京中医医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-19 

伦理委员会联系人:

王晶 

Contact Name of the ethic committee:

Jing Wang 

伦理委员会联系地址:

中国北京市东城区美术馆后街23号 

Contact Address of the ethic committee:

23 Art Gallery Backstreet, 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:

首都医科大学附属北京中医医院 

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

中国北京市东城区美术馆后街23号 

Primary sponsor's address:

23 Art Gallery Backstreet, 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):

首都医科大学附属北京中医医院

具体地址:

东城区美术馆后街23号

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Address:

23 Art Gallery Backstreet, Dongcheng District

经费或物资来源:

北京市科学技术委员会 

Source(s) of funding:

Beijing Municipal Science & Technology Commission 

研究疾病:

泌尿系结石急性肾绞痛 

Target disease:

acute renal colic caused by urinary calculi 

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:

探索性研究/预试验 

Study phase:

研究目的:

观察针刺治疗泌尿系结石所致肾绞痛的有效性及安全性。 

Objectives of Study:

To investigate the efficacy and safety of acupuncture for acute renal colic caused by urinary calculi. 

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. 符合泌尿系结石所致肾绞痛诊断标准(欧洲泌尿协会指南2017版); 2. 年龄18-75岁(性别不限); 3. 中重度肾绞痛(VAS≥4)患者; 4. 签署知情同意书。 

Inclusion criteria

1. Diagnosed according to European Association of Urology guideline (2017). 2. Aged 18–75 years (either sex). 3. Patients with moderate to severe renal colic (Visual Analogue Scale, VAS>=4). 4. Written informed consent. 

排除标准:

1. 就诊前6h曾接受过镇痛治疗者; 2. 对双氯芬酸钠、吗啡及山莨菪碱过敏,曾因服乙酰水杨酸或其他含有前列腺素合成酶抑制剂的药物而诱发哮喘、荨麻疹或过敏性鼻炎史者; 3. 充血性心力衰竭(NYHAII-IV),急性缺血性心脏病,周围血管病者; 4. 急性脑血管疾病,颅内压增高者; 5. 肝、肾功能衰竭者; 6. 活动性消化性溃,幽门梗阻,肠梗阻者; 7. 血液系统疾病:如血友病,凝血障碍的患者;血小板减少(<50×10^9/L);使用抗凝药物者; 8. 青光眼,眼压升高者; 9. 针刺有过严重不良反应者; 10. 针刺部位皮肤感染者; 11. 有精神性疾病或有药物滥用史,或有严重的认知缺损者; 12. 妊娠期或哺乳期妇女。 

Exclusion criteria:

1. Use of any analgesia in last 6 hours. 2. Allergic to diclofenac, morphine, or anisodamine; history of asthma, urticaria or allergic rhinitis induced by taking acetylsalicylic acid or other drugs containing prostaglandin synthase inhibitors. 3. Congestive heart failure, acute ischemic heart disease, or peripheral vascular disease. 4. Acute cerebrovascular disease, increased intracranial pressure. 5. Renal or liver failure. 6. Active digestive ulcer, pyloric obstruction, or intestinal obstruction. 7. Blood system diseases: such as hemophilia, coagulation disorders in patients; Thrombocytopenia (< 50x10^9/L); Using anticoagulants. 8. Glaucoma, elevated intraocular pressure. 9. People who have had serious adverse reactions to acupuncture. 10. Acupuncture site of skin infection. 11. Have a history of mental illness or substance abuse, or have severe cognitive impairment. 12. Pregnant or lactating. 

研究实施时间:

Study execute time:

From2018-06-01To 2021-08-31 

征募观察对象时间:

Recruiting time:

From2019-08-30To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

experimental group

Sample size:

干预措施:

针刺+双氯芬酸钠

干预措施代码:

Intervention:

acupuncture + Diclofenac sodium

Intervention code:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

假针刺+双氯芬酸钠

干预措施代码:

Intervention:

sham acupuncture + Diclofenac sodium

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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

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 Affiliated to Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

有效应答率(VAS较基线减少≥50%的患者比例)

指标类型:

主要指标 

Outcome:

Response rate (the proportion of participants whose pain reduced >= 50% compared with baseline)

Type:

Primary indicator 

测量时间点:

针刺治疗结束后10分钟

测量方法:

Measure time point of outcome:

10 min after acupuncture treatment

Measure method:

指标中文名:

VAS评分

指标类型:

次要指标 

Outcome:

Visual Analogue Scale

Type:

Secondary indicator 

测量时间点:

0~1、5、10、15、20、30、45、60分钟

测量方法:

Measure time point of outcome:

0~1, 5, 10, 15, 20, 30, 45, 60min

Measure method:

指标中文名:

有效应答率(VAS较基线减少≥50%的患者比例)

指标类型:

次要指标 

Outcome:

Response rate (the proportion of participants whose pain reduced >=50% compared with baseline)

Type:

Secondary indicator 

测量时间点:

0~1、5、15、20、30、45、60分钟

测量方法:

Measure time point of outcome:

0~1, 5, 15, 20, 30, 45, 60min

Measure method:

指标中文名:

补救镇痛率

指标类型:

次要指标 

Outcome:

The rate of patients requiring additional pain relief

Type:

Secondary indicator 

测量时间点:

针刺治疗结束后60分钟

测量方法:

Measure time point of outcome:

60 min after acupuncture treatment

Measure method:

指标中文名:

再次就诊率及入院率

指标类型:

次要指标 

Outcome:

Re-visit rate and admission rate

Type:

Secondary indicator 

测量时间点:

针刺治疗结束后72小时

测量方法:

Measure time point of outcome:

72 hours after acupuncture treatment

Measure method:

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

Adverse events

Type:

Secondary indicator 

测量时间点:

1周

测量方法:

Measure time point of outcome:

One week

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

采用区组随机,随机序列号由不参与试验实施、评估和分析的统计学专家(王丽琼,北京中医药大学)使用SAS软件产生。

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

The blocked randomization sequence was prepared by a professional statistician (Li-Qiong Wang, Beijing University of Chinese Medicine) with the SAS software, who is not involved in assessment, treatment or analysis.

盲法:

参与项目的患者、结果评估人员和统计人员将被设盲。

Blinding:

Blind method for subjects, evaluators and statisticians.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是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)。

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 IPD based on the ResMan platform (http://www.medresman.org).

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:

通过纸质CRF表格记录元数据,再由两人交叉核对将数据转录到epidata建立的数据库。数据管理由专人负责。

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 a CRF form, and then cross-checked and transcribed to an electronic database file based on Epidata software. All the daata management is handled by a dedicated person.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-16
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