电针治疗干眼症的临床疗效及免疫调节机制研究

注册号:

Registration number:

AMCTR-IOR-19000293 

注册号获得时间:

Date of releasing the registration number:

2019/9/25 22:25:32 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针治疗干眼症的临床疗效及免疫调节机制研究 

Public title:

Clinical Study for Efficacy of Electroacupuncture and its Immunomodulatory Mechanism in Dry Eye Syndrome Patients 

研究课题的正式科学名称:

电针治疗干眼症的临床疗效及免疫调节机制研究 

Scientific title:

Clinical Study for Efficacy of Electroacupuncture and its Immunomodulatory Mechanism in Dry Eye Syndrome Patients 

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:

杨光 

研究负责人:

马晓芃 

Applicant:

Guang Yang 

Study leader:

Xiaopeng Ma 

申请注册联系人电话:

Applicant telephone:

+86 18817818512 

研究负责人电话:

Study leader's telephone:

+86 13917140446 

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:

740304565@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

pengpengma@163.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:

上海市徐汇区宛平南路650号 

研究负责人通讯地址:

上海市徐汇区宛平南路650号 

Applicant address:

650 Wanping Road South, Xuhui District, Shanghai, China 

Study leader's address:

650 Wanping Road South, Xuhui District, Shanghai, 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:

上海市针灸经络研究所 

Applicant's institution:

Shanghai Research Institute of Acupuncture and Meridian 

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:

2019-101 

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-23 

研究实施负责(组长)单位:

上海市针灸经络研究所 

Primary sponsor:

Shanghai Research Institute of Acupuncture and Meridian 

研究实施负责(组长)单位地址:

上海市徐汇区宛平南路650号 

Primary sponsor's address:

650 Wanping Road South, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市针灸经络研究所

具体地址:

上海市徐汇区宛平南路650号

Institution
hospital:

Shanghai Research Institute of Acupuncture and Meridian

Address:

650 Wanping Road South, Xuhui District, Shanghai, China

经费或物资来源:

上海市卫生健康委员会,国家自然科学基金委员会 

Source(s) of funding:

Shanghai Municipal Health Commission,National Natural Science Foundation of China 

研究疾病:

干眼症 

Target disease:

Dry Eye 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:

其它 

Study phase:

Other 

研究目的:

对比观察电针、人工泪液治疗干眼症的临床疗效及对干眼症患者生活质量、精神状态、角膜灵敏度及泪膜分布规则性的改善作用;通过观察电针治疗前后干眼症患者IL-17、IL-21及circRNA表达的变化,探讨电针治疗干眼症的抗炎免疫机制 

Objectives of Study:

Comparing electroacupuncture with artificial tears in the clinical efficacy, improvement in quality of life, mental state, corneal sensitivity and tear film distribution regularity in patients with dry eye syndrome. Observing the expression changes of IL-17 IL-21 and circRNA, to reveal the anti-inflammatory immune mechanism of electroacupuncture treating dry eye syndrome. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1、符合干眼症诊断标准; 2、年龄18-65岁; 3、自愿加入试验,依从性良好,签订“知情同意书”。 

Inclusion criteria

1. Meeting the diagnosis criteria of DES; 2. Aged 18~65 years old; 3. Volunteer participants with fine compliance and having signed the informed consent. 

排除标准:

(1)合并有其他眼病(白内障、先天视网膜疾病、斜视、弱视、眼睑痉挛、结膜松弛症等); (2)近期(3个月内)有眼部活动性病变或眼科手术者; (3)对人工泪液过敏者; (4)近期(1个月内)接受过针灸治疗者; (5)妊娠期或哺乳期患者; (6)有干燥综合征、类风湿性关节炎、红斑狼疮、强直性脊柱炎等自身免疫性疾病者; (7)有心血管、脑血管、肝、肾和造血系统等严重全身性疾病及精神疾病者; (8)穴位皮肤有破损、溃疡、感染、疤痕者。 

Exclusion criteria:

1. Presence of other eye diseases, such as cataract, congenital retinal disease, strabismus, amblyopia, blepharospasm, conjunctivochalasis, etc; 2. Active lesion or recent ophthalmic surgery(in 3 months); 3. Alergic to artificial tears; 4. Accepted acupuncture treatment recently(in 1 month); 5. Women in pregnancy and lactation; 6. Presence of autoimmune diseases, such as Sjogren syndrome, rheumatoid arthritis, lupus erythematosus, ankylosing spondylitis, etc; 7. Presence of severe systemic diseases in the cardiovascular system, cerebrovascular system, liver, kidney and hematopoietic system; 8. Acupoint skin with injury, ulcer, infection, and scar. 

研究实施时间:

Study execute time:

From2019-08-26To 2021-07-31 

干预措施:

Interventions:

组别:

试验组

样本量:

42

Group:

Group 1

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electroacupuncture

Intervention code:

组别:

对照组

样本量:

42

Group:

Group 2

Sample size:

干预措施:

人工泪液

干预措施代码:

Intervention:

Artificial tears

Intervention code:

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:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市针灸经络研究所 

单位级别:

二级单位 

Institution
hospital:

Shanghai Research Institute of Acupuncture and Meridian  

Level of the institution:

Secondary unit 

测量指标:

Outcomes:

指标中文名:

眼表疾病指数

指标类型:

主要指标 

Outcome:

Ocular surface disease index

Type:

Primary indicator 

指标中文名:

泪膜破裂时间

指标类型:

主要指标 

Outcome:

Break up time

Type:

Primary indicator 

指标中文名:

泪液分泌量

指标类型:

主要指标 

Outcome:

Schimer test I

Type:

Primary indicator 

指标中文名:

角膜荧光染色

指标类型:

主要指标 

Outcome:

Fluorescent staining

Type:

Primary indicator 

指标中文名:

泪河高度

指标类型:

主要指标 

Outcome:

Tear meniscus height

Type:

Primary indicator 

指标中文名:

角膜知觉

指标类型:

次要指标 

Outcome:

Corneal Sensation

Type:

Secondary indicator 

指标中文名:

角膜地形图

指标类型:

次要指标 

Outcome:

Corneal Topography

Type:

Secondary indicator 

指标中文名:

SF-36生活质量量表

指标类型:

次要指标 

Outcome:

SF-36 scale of life quality

Type:

Secondary indicator 

指标中文名:

HAD焦虑抑郁量表

指标类型:

次要指标 

Outcome:

HAD scale of anxiety and depression

Type:

Secondary indicator 

指标中文名:

白介素-17

指标类型:

附加指标 

Outcome:

IL-17

Type:

Additional indicator 

指标中文名:

白介素-21

指标类型:

附加指标 

Outcome:

IL-21

Type:

Additional indicator 

指标中文名:

环状RNA

指标类型:

附加指标 

Outcome:

CircRNA

Type:

Additional indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

结膜细胞

组织:

Sample Name:

Conjunctival cells

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:

泪液

组织:

Sample Name:

tears

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 65 years

随机方法(请说明由何人用什么方法产生随机序列):

采用分层区组随机化方法,将入选患者随机分入试验组或对照组

性别:

男性

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

Patients will be randomly assigned to experimental group or control group by stratified block randomization method.

Gender:

Male

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):

拟在形成论文并公开发表后公布研究数据

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

After paper published, we will disclose data for public.

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):

数据由上海针灸经络研究所统一保存和管理

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

Data will be saved and supvised by Shanghai Research Institute of Acupuncture and Meridian

创建人:

Creater Name:

 2019-09-25
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