“疏肝健脾”针法对慢性疲劳综合征患者肠道相关菌群影响的研究

注册号:

Registration number:

AMCTR-IPR-19000292 

注册号获得时间:

Date of releasing the registration number:

2019/9/28 20:55:49 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

“疏肝健脾”针法对慢性疲劳综合征患者肠道相关菌群影响的研究 

Public title:

Effect of 'Shugan Jianpi' Acupuncture on intestinal related microflora in patients with Chronic Fatigue Syndrome 

研究课题的正式科学名称:

“疏肝健脾”针法对慢性疲劳综合征患者肠道相关菌群影响的研究 

Scientific title:

Effect of 'Shugan Jianpi' Acupuncture on intestinal related microflora in patients with Chronic Fatigue Syndrome 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

谢亚娜 

研究负责人:

牟秋杰 

Applicant:

YANA XIE 

Study leader:

QIUJIE MOU 

申请注册联系人电话:

Applicant telephone:

+8613676400098 

研究负责人电话:

Study leader's telephone:

+8613161161511 

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:

20180935146@bucm.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

2313471206@qq.com 

申请单位网址(自愿提供):

Applicant 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:

北京市朝阳区北三环东路11号 

研究负责人通讯地址:

北京市朝阳区北三环东路11号 

Applicant address:

11 North Third Ring Road East, Chaoyang District, Beijing, China 

Study leader's address:

11 North Third Ring Road East, Chaoyang District, Beijing, China 

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:

北京中医药大学 

Applicant's institution:

Beijing University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019BZHYLL0206 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

北京中医药大学医学伦理分委员会 

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-01 

研究实施负责(组长)单位:

针灸推拿学院 

Primary sponsor:

Acupuncture And Massage College 

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号 

Primary sponsor's address:

11 North Third Ring Road East, Chaoyang District, Beijing, China 

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):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学

具体地址:

北京市朝阳区北三环东路11号

Institution
hospital:

Beijing University of Chinese Medicine

Address:

11 North Third Ring Road East, Chaoyang District, Beijing, China

经费或物资来源:

校级资助 

Source(s) of funding:

School Funding 

研究疾病:

慢性疲劳综合征 

Target disease:

Chronic Fatigue Syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

通过评价患者疲劳量表-14(FS-14)和焦虑自评量表(SAS)的变化,明确“疏肝健脾”针法对CFS患者的调节效应;通过采用16S rRNA技术观察患者肠道菌群的变化,阐释“疏肝健脾”针法可以通过调节肠道菌群失调,从而发挥其治疗作用,为“疏肝健脾”针法调节CFS的科学假说提供客观可靠的临床实验证据。 

Objectives of Study:

By evaluating the changes of fatigue scale-14 (FS-14) and self-rating anxiety scale (SAS), the regulatory effect of "Shugan Jianpi" acupuncture on CFS patients was clarified. By using 16s rRNA technique to observe the changes of intestinal flora in patients, to explain that the acupuncture method of "Shugan Jianpi " can exert its therapeutic effect by regulating the imbalance of intestinal flora. The purpose of this study is to provide objective and reliable clinical experimental evidence for the scientific hypothesis of regulating CFS by "Shugan Jianpi" acupuncture. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)同时符合西医疾病诊断标准和中医证候诊断标准者; (2)年龄17~59岁者; (3)愿意接受治疗,签署知情同意书者。 

Inclusion criteria

(1) according with the diagnostic criteria of western medicine and TCM syndrome at the same time; (2) aged between 17 and 59; (3) willing to receive treatment and sign informed consent. 

排除标准:

(1)处于哺乳期或妊娠期的妇女; (2)有原发性疾病者; (3)同时使用其他疗法治疗此病者; (4)晕针的患者或对针刺疼痛感不能耐受者; (5)合并感染或出血者; (6)合并肝、肾、心血管、消化、造血系统等原发性疾病及精神性疾病者。 

Exclusion criteria:

(1) women who are lactating or pregnant; (2) patients with primary diseases; (3) patients who were treated with other treatments at the same time; (4) patients with fainting acupuncture or those who can not tolerate acupuncture pain; (5) complicated with infection or bleeding; (6) patients with primary diseases such as liver, kidney, cardiovascular, digestive and hematopoietic system and mental diseases. 

研究实施时间:

Study execute time:

From2019-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

针刺组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

“疏肝健脾”协定处方

干预措施代码:

Intervention:

'Shugan Jianpi' Acupuncture

Intervention code:

组别:

假针刺组

样本量:

20

Group:

Control group

Sample size:

干预措施:

穴周非穴点针刺

干预措施代码:

Intervention:

Sham acupuncture: acupuncture at non-acupoints

Intervention code:

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学国医堂门诊部 

单位级别:

一级 

Institution
hospital:

Outpatient Department of Chinese Medicine Hall, Beijing University of traditional Chinese Medicine  

Level of the institution:

Primary 

测量指标:

Outcomes:

指标中文名:

16s rRNA

指标类型:

主要指标 

Outcome:

16s rRNA

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

粪便

组织:

Sample Name:

feces

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 17 years
最大 Max age 59 years

随机方法(请说明由何人用什么方法产生随机序列):

研究员使用随机数字表法产生随机序列,排序后进行随机分组

性别:

男女均可

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

The researchers used the random number table method to generate random sequences, which were sorted and randomly grouped.

Gender:

Both

盲法:

Blinding for the participants

Blinding:

Blinding for the participants

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020年年中实验完成后公开,通过上传EXCELL文件至ResMan, http://www.medresman.org

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

After the experiment is completed, it is disclosed by uploading the EXCELL file to ResMan, http://www.medresman.org.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

原始数据将由ResMan保管

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Original data will be reposed by ResMan

创建人:

Creater Name:

 2019-09-25
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