针刺心经原穴对正常人视网膜血管血氧饱和度影响的研究方案

注册号:

Registration number:

AMCTR-IOR-19000289 

注册号获得时间:

Date of releasing the registration number:

2019/8/4 22:21:02 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺心经原穴对正常人视网膜血管血氧饱和度影响的研究方案 

Public title:

Research Program on the Effect of Acupuncture at the Original Point of Heart Meridian on Blood Oxygen Saturation of Retinal Vessels in Normal People 

研究课题的正式科学名称:

针刺心经原穴对正常人视网膜血管血氧饱和度影响的研究方案 

Scientific title:

Research Program on the Effect of Acupuncture at the Original Point of Heart Meridian on Blood Oxygen Saturation of Retinal Vessels in Normal People 

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:

龙迭戈 

研究负责人:

蹇文渊 

Applicant:

Long Diege 

Study leader:

Jian Wenyuan 

申请注册联系人电话:

Applicant telephone:

+86 18408203921 

研究负责人电话:

Study leader's telephone:

+86 18180747007 

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:

619403687@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

rh78@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:

四川省成都市金牛区十二桥路37号 

研究负责人通讯地址:

四川省成都市金牛区十二桥路37号 

Applicant address:

37 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, China 

Study leader's address:

37 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, 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:

成都中医药大学/眼科学院 

Applicant's institution:

Chengdu University of Traditional Chinese Medicine/Academy of Ophthalmology 

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:

2019yh-001 

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:

成都中医大银海眼科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Dayinhai Ophthalmological Hospital of Chengdu Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-05 

研究实施负责(组长)单位:

成都中医药大学/眼科学院 

Primary sponsor:

Chengdu University of Traditional Chinese Medicine/Academy of Ophthalmology 

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路37号 

Primary sponsor's address:

37 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医大银海眼科医院

具体地址:

金牛区星辉西路8号

Institution
hospital:

Chengdu University of TCM Ineye Hospital

Address:

8 Xinghui Road West, Jinniu District

经费或物资来源:

国家自然科学基金(81804151) 

Source(s) of funding:

National Natural Science Foundation (81804151) 

研究疾病:

健康受试者 

Target disease:

healthy subjects 

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:

其它 

Study phase:

Other 

研究目的:

通过观察针刺前后正常人视网膜血管特征的变化,论证经脉与视网膜的密切的关系;同时通过观察针刺前后眼部疾病患者的视网膜血管特征的变化,来加以证明通过针灸可以治疗相关眼部疾病,为针刺治疗眼部相关疾病提供直接依据,对眼病的治疗方法提供新的构想 

Objectives of Study:

In order to demonstrate the close relationship between meridians and retina, the changes of retinal vascular characteristics in retina of normal people before and after acupuncture were observed;At the same time, by observing the changes of retinal vascular characteristics in patients with eye diseases before and after acupuncture, we can prove that acupuncture can treat related eye diseases, provide direct basis for acupuncture treatment of eye-related diseases, and provide new ideas for the treatment of eye diseases. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.矫正视力≥0.8(国际标准视力表); 2.屈光度数+1.00D~ -3.00D范围内; 3.年龄 18-70 岁; 4.BMI值18.5-23.9范围内; 5.知情同意,志愿受试。 

Inclusion criteria

1. Corrected visual acuity (> 0.8) (international standard visual acuity chart); 2. diopter + 1.00D ~ - 3.00D range; 3. aged 18-70 years old; 4. BMI value within 18.5-23.9 range; 5. informed consent, volunteer subjects. 

排除标准:

1.妊娠、哺乳期妇女; 2.屈光介质混浊难以进行眼底图像评价者; 3.合并青光眼、葡萄膜炎、年龄相关性黄斑变性以及视神经病变等严重眼部疾病患者; 4.合并糖尿病、高血压、高脂血症、心血管疾病等及其他严重疾病、精神病患者; 5.具有长期吸烟史、饮酒史。 

Exclusion criteria:

1. Pregnant and lactating women; 2. Refractive media opacity is difficult to evaluate fundus images; 3. Patients with severe ocular diseases such as glaucoma, uveitis, age-related macular degeneration and optic neuropathy; 4. Patients with diabetes, hypertension, hyperlipidemia, cardiovascular disease, and other serious diseases and psychosis; 5. Long-term smoking and drinking history. 

研究实施时间:

Study execute time:

From2019-08-01To 2022-01-31 

干预措施:

Interventions:

组别:

Group 1

样本量:

60

Group:

Group 1

Sample size:

干预措施:

针刺心经原穴

干预措施代码:

Intervention:

Acupuncture of points on the original scheme

Intervention code:

组别:

Group 2

样本量:

60

Group:

Group 2

Sample size:

干预措施:

针刺非经非穴

干预措施代码:

Intervention:

Acupuncture of non-acupoints

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都中医大银海眼科医院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu University of TCM Ineyehospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

视网膜血氧饱和度

指标类型:

主要指标 

Outcome:

Retinal oxygen saturation

Type:

Primary indicator 

指标中文名:

视网膜血管弯曲度

指标类型:

主要指标 

Outcome:

Retinal vascular curvature

Type:

Primary indicator 

指标中文名:

视网膜血管管径

指标类型:

主要指标 

Outcome:

Retinal vascular diameter

Type:

Primary indicator 

指标中文名:

视力

指标类型:

主要指标 

Outcome:

Vision

Type:

Primary indicator 

指标中文名:

眼轴

指标类型:

主要指标 

Outcome:

Eye axis

Type:

Primary indicator 

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

blood sugar

Type:

Primary indicator 

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

指标中文名:

眼压

指标类型:

主要指标 

Outcome:

intra-ocular tension

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

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:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

由专门的研究人员,用EXCEL软件生成一组随机数字表,将序号、组别、随机数字分别填写并装入不透明的信封并密封。健康受试者就诊时,经研究人员确定符合纳入标准,则按受试者就诊的先后顺序确定序号,并开启信封,以确定受试者所在组别便选择相应的治疗方法,并做好病例报告表的相关登记

性别:

男女均可

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

A set of random number tables is generated by special researchers using EXCEL software. The serial number, group number and random number are filled in and sealed in opaque envelopes. When the healthy subjects are treated, the researchers confirm that they meet the inclusion criteria, then the serial number

Gender:

Both

盲法:

未说明

Blinding:

Not stated

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):

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

none

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CRF表

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

Original CRF table

创建人:

Creater Name:

 2019-08-04
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