子午流注针法治疗新型冠状病毒感染相关失眠的临床疗效评价

注册号:

Registration number:

ITMCTR2024000451

最近更新日期:

Date of Last Refreshed on:

2024-09-17

注册时间:

Date of Registration:

2024-09-17

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

子午流注针法治疗新型冠状病毒感染相关失眠的临床疗效评价

Public title:

Clinical efficacy assessment of Zhiwu Liuzhu acupuncture therapy for insomnia associated with novel coronavirus infection covid-19

注册题目简写:

English Acronym:

研究课题的正式科学名称:

子午流注针法治疗新型冠状病毒感染相关失眠的临床疗效评价

Scientific title:

Clinical efficacy assessment of Zhiwu Liuzhu acupuncture therapy for insomnia associated with novel coronavirus infection covid-19

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:

范轶斌

研究负责人:

范轶斌

Applicant:

FANYIBIN

Study leader:

FANYIBIN

申请注册联系人电话:

Applicant telephone:

+8613585592212

研究负责人电话:

Study leader's telephone:

+8613585592212

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:

logohome@qq.com

研究负责人电子邮件:

Study leader's E-mail:

logohome@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:

上海市浦东新区大同路358号上海市第七人民医院

研究负责人通讯地址:

上海市浦东新区大同路358号上海市第七人民医院

Applicant address:

Shanghai Seventh People's Hospital, No. 358 Datong Road, Pudong New Area, Shanghai

Study leader's address:

Shanghai Seventh People's Hospital, No. 358 Datong Road, Pudong New Area, Shanghai

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:

上海市第七人民医院

Applicant's institution:

Shanghai Seventh People's Hospital

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:

2024-7h-HIRB-021

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:

上海市第七人民医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai Seventh People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/12 0:00:00

伦理委员会联系人:

张春燕

Contact Name of the ethic committee:

ZhangChunyan

伦理委员会联系地址:

上海市浦东新区大同路358号上海市第七人民医院

Contact Address of the ethic committee:

Shanghai Seventh People's Hospital, No. 358 Datong Road, Pudong New Area, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+02158670561

伦理委员会联系人邮箱:

Contact email of the ethic committee:

101836411@qq.com

研究实施负责(组长)单位:

上海市第七人民医院

Primary sponsor:

Shanghai Seventh People's Hospital

研究实施负责(组长)单位地址:

上海市浦东新区大同路358号上海市第七人民医院

Primary sponsor's address:

Shanghai Seventh People's Hospital, No. 358 Datong Road, Pudong New Area, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

浦东新区

Country:

China

Province:

Shanghai

City:

Pudong New Area

单位(医院):

上海市第七人民医院

具体地址:

上海市浦东新区大同路358号

Institution
hospital:

Shanghai Seventh People's Hospital

Address:

Shanghai Seventh People's Hospital, No. 358 Datong Road, Pudong New Area, Shanghai

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

失眠

研究疾病代码:

Target disease:

insomnia

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究拟借助国际标准统一睡眠率公式、匹兹堡睡眠质量指数(PSQI)和失眠症状疗效,对子午流注针刺改善新型冠状病毒感染相关失眠症状进行临床疗效及安全性,旨在有效改善患者的失眠症状,并开展临床推广应用。

Objectives of Study:

This study aims to effectively improve the insomnia symptoms of patients with the help of the international standard unified sleep rate formula, the Pittsburgh Sleep Quality Index (PSQI) and the efficacy of insomnia symptoms, aiming to effectively improve the insomnia symptoms of patients and carry out clinical application.

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感染新冠病毒同时或之后会出现失眠相关症状; ②年龄18-80周岁,男女性均可纳入; ③自愿参加,并积极配合,签署知情同意书。

Inclusion criteria

(1) Insomnia-related symptoms occur at or after infection with the new coronavirus; (2) Age 18-80 years old, both men and women can be included; (3) Participate voluntarily and actively cooperate with the signing of the informed consent form.

排除标准:

①凡不符合纳入标准者。 ②凡是已产生对安定类药物依赖者(偶尔服用安定者则需停药7天以上)。 ③在研究前1周使用过抗精神病药、抗抑郁药者。 ④严重肝、肾功能不全者,或合并其他各系统严重疾病者。 ⑤精神病患者或恶性肿瘤患者。 ⑥按规定治疗,无法判断疗效或资料不全等影响疗效和安全性判定者。

Exclusion criteria:

(1) Those who do not meet the inclusion criteria. (2) Those who have developed dependence on diazepam drugs (those who occasionally take diazepam need to stop taking the drug for more than 7 days). (3) Those who have used antipsychotics and antidepressants in the 1 week before the study. (4) Patients with severe liver and kidney insufficiency, or those with serious diseases of other systems. (5) Patients with mental illness or malignant tumors. (6) Those who are unable to judge the efficacy or incomplete data that affect the efficacy and safety judgment according to the prescribed treatment.

研究实施时间:

Study execute time:

From 2024-09-20

To      2025-03-31

征募观察对象时间:

Recruiting time:

From 2024-09-20

To      2024-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

33

Group:

Control group

Sample size:

干预措施:

普通针刺

干预措施代码:

Intervention:

Ordinary acupuncture

Intervention code:

组别:

治疗组

样本量:

33

Group:

Treatment group

Sample size:

干预措施:

子午流注针刺

干预措施代码:

Intervention:

Zhiwu Liuzhu acupuncture

Intervention code:

样本总量 Total sample size : 66

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

Province:

City:

单位(医院):

上海市第七人民医院

单位级别:

三甲医院

Institution/hospital:

Level of the institution:

grade-A

测量指标:

Outcomes:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index Scale

Type:

Secondary indicator

测量时间点:

测量方法:

问卷积分评定

Measure time point of outcome:

Measure method:

指标中文名:

国际标准统一睡眠率公式

指标类型:

主要指标

Outcome:

The international standard harmonizes the sleep rate formula

Type:

Primary indicator

测量时间点:

测量方法:

睡眠率=(实际入睡时间/上床至起床总时间)×100%

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:

no

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 80
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):

由一名研究人员采用SPSS软件随机分组,根据随机数字表产生随机数列,该研究人员不参与采集数据与统计。

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

A researcher, who is not involved in the collection of data and statistics, generates a random number series based on a table of random numbers with SPSS software.

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):

不共享原始数据

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

Do not share original data

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:

采用病例记录表进行数据管理

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

Case Record Form were used for data management

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):

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