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To explore the clinical study of Zang Fu organs corresponding to Wu Yin audio frequency in traditional Chinese medicine

注册号：

Registration number：

ITMCTR2022000045

最近更新日期：

Date of Last Refreshed on：

2022-07-30

注册时间：

Date of Registration：

2022-06-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中医脏腑对应五音单音音频的临床研究

Public title：

To explore the clinical study of Zang Fu organs corresponding to Wu Yin audio frequency in traditional Chinese medicine

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中医脏腑对应五音单音音频的临床研究

Scientific title：

To explore the clinical study of Zang Fu organs corresponding to Wu Yin audio frequency in traditional Chinese medicine

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：

ChiCTR2200062216 ; ChiMCTR2200006390

申请注册联系人：

黄梦文

研究负责人：

提桂香

Applicant：

Huang Meng-wen

Study leader：

Ti Gui-xiang

申请注册联系人电话：

Applicant telephone：

13949013154

研究负责人电话：

Study leader's telephone：

13671298600

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：

huangmengwen21@163.com

研究负责人电子邮件：

Study leader's E-mail：

zytgxwzz@hotmail.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：

北京市西城区北线阁5号中国中医科学院广安门医院

研究负责人通讯地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Applicant address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, Xicheng District, Beijing

Study leader's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, Xicheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100053

研究负责人邮政编码：

Study leader's postcode：

100053

申请人所在单位：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen 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：

2022-157-KY

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：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2022/7/12 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Qiao Jie

伦理委员会联系地址：

中国中医科学院广安门医院

Contact Address of the ethic committee：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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：

北京市西城区北线阁5号中国中医科学院广安门医院

Primary sponsor's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, 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

市(区县)：

西城区

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Institution
hospital：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, Xicheng District, Beijing

经费或物资来源：

中国中医科学院科技创新工程重大攻关项目（CI2021A03009）

Source(s) of funding：

Major Key Projects of Science and Technology Innovation Project of China Academy of Chinese Medical Sciences （CI2021A03009）

研究疾病：

五音疗法

研究疾病代码：

Target disease：

Five tone therapy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

1.通过统计分析体感声波对十二经原穴微循环改变程度，探索与十二经络原穴对应的单音音频；通过原穴所在的经络对应的脏腑，确定脏腑对应的单音音频，进一步明确与古代文献记载五音六律对应的标准音。 2.本研究旨在为五音疗法防治疾病提供科学依据，为推广五音疗法在中医养生与康复领域的应用提供理论基础。

Objectives of Study：

1. Through statistical analysis of the degree of changes in the microcirculation of the original acupoints of the twelve meridians by somatosensory sound waves, explore the monophonic audio corresponding to the original acupoints of the twelve meridians; through the viscera corresponding to the meridian where the original acupoint is located, determine the monophonic audio corresponding to the viscera, and further The standard sound corresponding to the five-tone six-law recorded in ancient documents is clearly defined. 2. The purpose of this study is to provide a scientific basis for the prevention and treatment of diseases with five-tone therapy, and to provide a theoretical basis for promoting the application of five-tone therapy in the field of TCM health preservation and rehabilitation.

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18-60岁（含边界值），性别不限；（2）近1年内体检项目如血尿便常规、生化全项、心电图及神经系统检查等检测指标无明显异常，且未进行重大手术，腕踝关节无明显异常，无偏瘫及肢体活动不利，经课题组评判为身体健康者；（3）精神正常且近1年内无神经、精神类疾病，身心未受重大创伤且依从性强，能有效配合完成试验者，并经焦虑自评量表（SAS）、抑郁自评量表（SDS）评定为非焦虑、抑郁状态；（4）无慢性疾病病史，无重大家族遗传病病史；（5）受试者自愿参加本课题研究并签署知情同意书。

Inclusion criteria

(1) The age is 18-60 years old (including the boundary value), and the gender is not limited; (2) In the past 1 year, there are no obvious abnormalities in the physical examination items such as blood and urine routine, biochemical comprehensive items, electrocardiogram and neurological examination and other test indicators, and have not been carried out. Major surgery, no obvious abnormality in the wrist and ankle joints, no hemiplegia and unfavorable physical activity, and judged by the research team as healthy; (3) Normal spirit, no neurological or psychiatric diseases in the past 1 year, no major physical and mental trauma and compliance Strong, able to effectively cooperate with those who completed the test, and were rated as non-anxious and depressive by the Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS); (4) No history of chronic diseases, no history of major family genetic diseases ; (5) Subjects voluntarily participated in this research and signed the informed consent.

排除标准：

（1）妊娠、准备妊娠或哺乳期女性；（2）参加实验前1周内有服药史及其他内外治法治疗史者；（3）过敏体质及有严重幽闭恐惧症者及其他精神疾病患者；（4）正在参加其它临床试验或近一月内参加过其它临床试验者；（5）因各种原因不能久卧者。

Exclusion criteria：

(1) Women who are pregnant, planning to become pregnant or breastfeeding; (2) Those who have a history of taking medication and other internal and external therapy within 1 week before participating in the experiment; (3) Those with allergic constitution, severe claustrophobia and other mental illnesses ; (4) Those who are participating in other clinical trials or have participated in other clinical trials within the past month; (5) Those who cannot sleep for a long time due to various reasons.

研究实施时间：

Study execute time：

从From 2021-10-01

至To      2024-10-01

征募观察对象时间：

Recruiting time：

从From 2022-08-01

至To      2023-12-01

干预措施：

Interventions：

组别：

干预组

样本量：

69

Group：

intervention group

Sample size：

干预措施：

48个单音音频

干预措施代码：

Intervention：

48 monophonic audio

Intervention code：

样本总量 Total sample size ： 69

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)：

西城区

Country：

China

Province：

Beijing

City：

单位(医院)：

北京市西城区北线阁5号中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, Xicheng District, Beijing

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

微循环变化量

指标类型：

主要指标

Outcome：

Microcirculation Variation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

氧分压

指标类型：

次要指标

Outcome：

partial pressure of oxygen

Type：

Secondary 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：

尿液

组织：

Sample Name：

urine

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：

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 60 岁
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）：

利用Stata统计软件生成随机数字，随机对十二经原穴先后测定；本次研究计划受试者人数为69例，研究对象为十二经络原穴共12个穴位，所用音波序列共12段。

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

Stata statistical software was used to generate random numbers, and the original acupoints of the twelve meridians were randomly measured successively; the number of subjects in this research plan was 69 cases, and the research objects were a total of 12 acupoints of the original acupoints of the twelve&#32

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

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）：

以文章发表的形式公开

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

Make it public in the form of an article

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：

我们使用病例报告表（CRF）进行数据的采集，使用Epi Info软件进行数据的管理。根据CRF表格的项目采用软件建立本试验专用的数据库系统，数据管理员对病例报告表进行检查及数据同步录入，数据的审核先采用Epi Info软件中的核查功能，再随机抽取10份病例报告表和数据库中的数据进行人工比较，以确保数据库中的数据与CRF中的结果一致。

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

We used case report form (CRF) for data collection and Epi Info software for data management. According to the items in the CRF form, a software is used to establish a database system dedicated to this trial. The data administrator checks the case report form and enters the data synchronously. The data review first uses the verification function in the Epi Info software, and then randomly selects 10 case report forms. Manual comparisons were made with the data in the database to ensure that the data in the database was consistent with the results in the CRF.

数据管理委员会：

Data Managemen Committee：

有

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):

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