Study on the improvement of clinical symptoms and mechanism of acupuncture in amyotrophic lateral sclerosis

注册号:

Registration number:

ITMCTR2024000135

最近更新日期:

Date of Last Refreshed on:

2024-07-28

注册时间:

Date of Registration:

2024-07-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺对肌萎缩侧索硬化症临床症状的改善作用及机制研究

Public title:

Study on the improvement of clinical symptoms and mechanism of acupuncture in amyotrophic lateral sclerosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺对肌萎缩侧索硬化症临床症状的改善作用及机制研究

Scientific title:

Study on the improvement of clinical symptoms and mechanism of acupuncture in amyotrophic lateral sclerosis

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:

王天琪

研究负责人:

王天琪

Applicant:

Tianqi Wang

Study leader:

Tianqi Wang

申请注册联系人电话:

Applicant telephone:

15600119690

研究负责人电话:

Study leader's telephone:

15600119690

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:

1214363525@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1214363525@qq.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:

北京市丰台区右安门外西头条10号首都医科大学

研究负责人通讯地址:

北京市丰台区右安门外西头条10号首都医科大学

Applicant address:

Capital Medical University, No.10, Xitoutiao, You 'an Men, Fengtai District, Beijing

Study leader's address:

Capital Medical University, No.10, Xitoutiao, You 'an Men, Fengtai 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

Applicant's institution:

Capital Medical University

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:

Z2024SY032

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

首都医科大学

Name of the ethic committee:

Capital Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/17 0:00:00

伦理委员会联系人:

李智宏

Contact Name of the ethic committee:

Zhihong Li

伦理委员会联系地址:

北京市丰台区右安门外西头条10号首都医科大学

Contact Address of the ethic committee:

Capital Medical University, No.10, Xitoutiao, You 'an Men, Fengtai District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-83911638

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lizhihong@ccmu.edu.cn

研究实施负责(组长)单位:

首都医科大学

Primary sponsor:

Capital Medical University

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条10号首都医科大学

Primary sponsor's address:

Capital Medical University, No.10, Xitoutiao, You 'an Men, Fengtai 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):

丰台

Country:

CHINA

Province:

Beijing

City:

Fengtai

单位(医院):

首都医科大学中医门诊部

具体地址:

北京市丰台区右安门外西头条10号

Institution
hospital:

Capital Medical University of traditional Chinese Medicine outpatient department

Address:

No.10, Xitoutiao, outside You 'an Gate, Fengtai District, Beijing

经费或物资来源:

北京市教育委员会科技计划一般项目

Source(s) of funding:

Beijing Municipal Education Commission science and technology plan general project

研究疾病:

肌萎缩侧索硬化症

研究疾病代码:

Target disease:

Amyotrophic lateral sclerosis

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:

从临床角度,验证针刺基于中医“治痿独取阳明”理论在治疗肌萎缩侧索硬化症的理论内涵及现代生物学依据

Objectives of Study:

From the clinical point of view, to verify the theoretical connotation and modern biological basis of acupuncture in the treatment of amyotrophic lateral sclerosis based on the theory of "treating impotence and taking Yang Ming" of traditional Chinese medicine

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)年龄 30~70 岁,性别不限; (2)所有病例均符合 2012 年新版《中国肌萎缩侧索硬化诊断和治疗指南》。 (3)自愿参加试验并签署知情同意书者

Inclusion criteria

(1) Age 30 ~ 70 years old, gender is not limited; (2) All cases were in accordance with the 2012 edition of the Chinese Guidelines for Diagnosis and Treatment of amyotrophic lateral sclerosis. (3) Those who voluntarily participate in the experiment and sign the informed consent

排除标准:

(1)患有心、脑、肝、肾等疾患,或合并其他各系统严重疾病者; (2)存在药物依赖者; (3)凝血功能障碍,严重过敏体质或严重晕针者。

Exclusion criteria:

(1) suffering from diseases of the heart, brain, liver, kidney, or other serious diseases of other systems; (2) Drug dependence exists; (3) Coagulation dysfunction, severe allergy or severe dizziness.

研究实施时间:

Study execute time:

From 2024-01-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2025-01-01

To      2026-12-31

干预措施:

Interventions:

组别:

针刺组

样本量:

10

Group:

Acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

对照组

样本量:

10

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

样本总量 Total sample size : 20

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):

丰台

Country:

China

Province:

Beijing

City:

Fengtai

单位(医院):

首都医科大学中医门诊部

单位级别:

三级

Institution/hospital:

Capital Medical University of traditional Chinese Medicine outpatient department

Level of the institution:

three-level

测量指标:

Outcomes:

指标中文名:

肌萎缩侧索硬化功能评分量表

指标类型:

主要指标

Outcome:

Amyotrophic lateral sclerosis functional score scale

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5ml

组织:

Sample Name:

Blood sample 5ml

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

粪便

组织:

Sample Name:

Stool sample

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:

尚未开始

Not yet recruiting

年龄范围:

最小 30
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):

应用SAS软件编程产生随机号码,进行中央区组随机

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

SAS software was used to generate random numbers and perform group randomization in the central area

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):

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

None

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,电子采集和管理系统

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

Case Record Form, CRF and Electronic Data Capture, EDC

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above