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针刺治疗肝火犯胃型失眠随机对照试验

注册号：

Registration number：

ITMCTR2024000615

最近更新日期：

Date of Last Refreshed on：

2024-10-28

注册时间：

Date of Registration：

2024-10-28

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

针刺治疗肝火犯胃型失眠随机对照试验

Public title：

Effect of acupuncture on insomnia associated with Liver fire invading stomach pattern insomnia: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺治疗肝火犯胃型失眠随机对照试验

Scientific title：

Effect of acupuncture on insomnia associated with Liver fire invading stomach pattern insomnia: A Randomized Controlled Trial

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：

Nani Maiya Gurung

研究负责人：

Applicant：

Nani Maiya Gurung

Study leader：

Chen Yunfei

申请注册联系人电话：

Applicant telephone：

+86 18616532730

研究负责人电话：

Study leader's telephone：

+86 13917922206

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：

drnaanugurung703@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

icyf1968@163.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：

上海浦东新区张江高科技园区华佗路280弄3幢4号

研究负责人通讯地址：

Applicant address：

Shanghai Pudong Zhangjiang high-tech park Huatuo Road 280 Building 3-4

Study leader's address：

Gan He Road 110 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：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

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：

2024-089

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：

Name of the ethic committee：

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/24 0:00:00

伦理委员会联系人：

殷老师

Contact Name of the ethic committee：

Yin Cong Quan

伦理委员会联系地址：

上海市甘河路110号

Contact Address of the ethic committee：

Gan He Road 110 Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-65161782*8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

Primary sponsor：

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

Primary sponsor's address：

Gan He Road 110 Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

具体地址：

Institution
hospital：

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Address：

Gan He Road 110 Shanghai

经费或物资来源：

Source(s) of funding：

Department

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：

其它

Others

研究目的：

Objectives of Study：

• To evaluate the effect of acupuncture in Liver fire invading stomach pattern insomnia. • To explore the central mechanism of acupuncture in Liver fire invading stomach pattern insomnia.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Patients should meet the following criteria to be enrolled in the study: (1)aged ≥18 and ≤ 65 years old; both male and female (2) diagnosed with insomnia in accordance with the International Classification of Sleep Disorders- third edition (ICSD-3); (3) meet the TCM diagnostic criteria of insomnia (conform to the differentiation standard of liver fire invading stomach); (4) ISI score >7 points and < 22 points moderate insomnia; (5) the patient signed the informed consent and voluntarily participated in the study. Inclusion Criteria for fMRI (1) Patients meeting the criteria in 3.2.3.1. (2) Right-handed (3) No illnesses related to Central Nervous System (4) No MRI contraindications (eg metal implants claustrophobia etc.). (5) Have not taken sedative hypnosis drugs within 3 months before entering this study and cannot take similar drugs and health products during treatment and follow-up; (6) Voluntarily perform a total of 2 multifunctional MRI scans and sign the informed consent form. Inclusion criteria for healthy controls (1) Aged ≥18 and ≤ 65 years old; (2) PSQI ≤ 5 points; (3) Right-handed; (4) Havent worked night shift in 3 months; (5) Not suffering from any systemic illnesses or organic lesions of the brain; (6) Not addicted to smoking alcohol etc and not following any special sleep and dietary regime; (7) Those who do not have contraindications to magnetic resonance examination (such as metal implants claustrophobia etc.); (8) Voluntarily agrees to do fMRI once and sign the informed consent form.

排除标准：

Exclusion criteria：

The study will not include patients if: (1) With severe primary diseases in the cardiovascular system pulmonary system liver kidney and hematopoietic system; or systemic diseases such as pain fever cough surgery etc.; (2) With obvious headache migraine or history of head trauma or mental illness; (3) Insomnia caused by alcohol abuse and/or psychotropic substance abuse and dependence (including sleeping pills); (4) Other types of sleep disorders such as sleep apnea restless legs syndrome (PSG shows sleep apnea-hypopnea index ≥ 10 events /hr or PSG shows sleep periodic limb movements >15 times/hr); sleep disorders of shift workers etc.; (5) Patient is pregnant or lactating or planning for pregnancy; (6) Patient has participated in another clinical trials in the last 3 months. (7) Patients with severe visual auditory or language impairments; (8) Afraid of needles.

研究实施时间：

Study execute time：

从From 2024-07-25

至To      2025-02-24

征募观察对象时间：

Recruiting time：

从From 2024-07-25

至To      2024-12-24

干预措施：

Interventions：

组别：

样本量：

15

Group：

Healthy Control

Sample size：

干预措施：

干预措施代码：

Intervention：

none

Intervention code：

组别：

样本量：

38

Group：

Treatment

Sample size：

干预措施：

干预措施代码：

Intervention：

Real Acupuncture

Intervention code：

组别：

样本量：

38

Group：

Control

Sample size：

干预措施：

干预措施代码：

Intervention：

Sham acupuncture

Intervention code：

样本总量 Total sample size ： 76

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

单位级别：

Institution/hospital：

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Class A tertiary comprehensive integrated traditional Chinese medicine and Western medicine hospital

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Beck Depression Inventory (BDI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Polysomnography (PSG) Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

fMRI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Sleep Diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Gastrointestinal Symptom Rating Scale (GSRS)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Beck Anxiety Inventory (BAI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

TCM syndrome scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Insomnia Severity Index (ISI)

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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 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）：

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

Patients who are interested in participating the trial will be initially screened via phone and then will be asked to do face-to-face interview to conduct further surveys. Participants meeting the inclusion criteria will be randomly divided into two equal groups in the ratio of 1:1 by a random number table using statistical software SPSS 28.0.

盲法：

Blinding：

Although it is hard to blind the practitioners due to the characteristics of the intervention they will be forbidden from disclosing the participant's allocation status and instructed to refrain from any needless conversations with patients. Patients will be asked to wear an eye mask to get a good rest and a better therapeutic effect. The real acupuncture and sham acupuncture groups will remain blinded throughout the study and a blinding test will be used to determine whether blinding was maintained.

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）：

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

Study protocol will be published.

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：

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

A CRF will be maintained to collect all the information of the participants including the adverse events and concominant medicinal use.

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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