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

Registration number：

ITMCTR2024000135

Date of Last Refreshed on：

2024-07-28

Date of Registration：

2024-07-28

Registration Status：

Prospective registration

Public title：

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

English Acronym：

Scientific title：

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

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Tianqi Wang

Study leader：

Tianqi Wang

Applicant telephone：

15600119690

Study leader's telephone：

15600119690

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1214363525@qq.com

Study leader's E-mail：

1214363525@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

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

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Capital Medical University

Approved by ethic committee：

Approved No. of ethic committee：

Z2024SY032

Approved file of Ethical Committee：

View

Name of the ethic committee：

Capital Medical University

Date of approved by ethic committee：

2024/7/17 0:00:00

Contact Name of the ethic committee：

Zhihong Li

Contact Address of the ethic committee：

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

Contact phone of the ethic committee：

010-83911638

Contact email of the ethic committee：

lizhihong@ccmu.edu.cn

Primary sponsor：

Capital Medical University

Primary sponsor's address：

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

Secondary sponsor：

Country：

CHINA

Province：

Beijing

City：

Fengtai

Institution
hospital：

Capital Medical University of traditional Chinese Medicine outpatient department

Address：

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

Source(s) of funding：

Beijing Municipal Education Commission science and technology plan general project

Target disease：

Amyotrophic lateral sclerosis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

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

Description for medicine or protocol of treatment in detail：

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

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.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2025-01-01

To      2026-12-31

Interventions：

10

Group：

Acupuncture group

Sample size：

Intervention：

Acupuncture

Intervention code：

10

Group：

Control group

Sample size：

Intervention：

Conventional treatment

Intervention code：

Total sample size ： 20

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Fengtai

Institution/hospital：

Capital Medical University of traditional Chinese Medicine outpatient department

Level of the institution：

three-level

Outcomes：

Outcome：

Amyotrophic lateral sclerosis functional score scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood sample 5ml

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Stool sample

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

30
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Blinding：

IPD sharing：

No

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

None

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

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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