针刺对青光眼患者的临床疗效观察

注册号:

Registration number:

AMCTR-IOR-19000242 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 18:46:10 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺对青光眼患者的临床疗效观察 

Public title:

Clinical effect observation for acupuncture on glaucoma patients 

研究课题的正式科学名称:

针刺对青光眼患者的临床疗效研究 

Scientific title:

Clinical effect research for acupuncture on glaucoma patients 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900020713 

申请注册联系人:

陆欣玲 

研究负责人:

陆欣玲 

Applicant:

Xinling Lu 

Study leader:

Xinling Lu 

申请注册联系人电话:

Applicant telephone:

+86 17717575627 

研究负责人电话:

Study leader's telephone:

+86 17717575627 

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:

popolo_1982@163.com 

研究负责人电子邮件:

Study leader's E-mail:

popolo_1982@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:

浦东新区华佗路280弄6幢9号123室 

研究负责人通讯地址:

浦东新区华佗路280弄6幢9号123室 

Applicant address:

Room 123, Building 9, Lane 280, Huatuo Road, Shanghai, China 

Study leader's address:

Room 123, Building 9, Lane 280, Huatuo Road, 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:

上海中医药大学 

Applicant's institution:

Shanghai University of Traditional Chinese Medicine, Shanghai , P. R. 

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:

2018-589-18-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiated with Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-08 

研究实施负责(组长)单位:

上海中医药大学 

Primary sponsor:

Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区蔡伦路1200号 

Primary sponsor's address:

1200 Cailun Road, 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):

上海市卫生健康委员会

具体地址:

世博村路300号4号楼

Institution
hospital:

Shanghai Municipal Health Commission

Address:

Building 4, 300 Expo Village Road

经费或物资来源:

上海市卫生健康委员会 

Source(s) of funding:

Shanghai Municipal Health Commission 

研究疾病:

青光眼 

Target disease:

Glaucoma 

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:

本课题基于针刺对青光眼的临床疗效和神经生长因子的积极作用,以及前期实验研究证明针刺可通过对视网膜神经节细胞NGF及其受体TrkA信号通路作用的影响,对视网膜神经节细胞产生保护作用。通过临床实验研究,在前期实验基础上,实现成果转化,进一步证明中医临床上采用针刺对青光眼的治疗效果,本研究将通过针刺青光眼患者合谷(LI4)、睛明(BL1)、球后(Ex-HN07),针刺青光眼患者风池(GB20)、翳明(EX-HN14)、行间(LR2)与药物基础治疗对照,结合患者针刺前后的视力、眼压、视野等指标进行综合评价;进一步证实针刺不仅能降低原发性青光眼的眼压,而且能减缓或控制视野的进一步损害,更明确相关穴位的特殊有效性。 

Objectives of Study:

Based on the clinical effect of acupuncture on glaucoma and the positive effect of nerve growth factor, as well as previous experimental studies, it has been proved that acupuncture can protect retinal ganglion cells by affecting NGF and TrkA signaling pathway of retinal ganglion cells. Through the clinical experimental study, on the basis of the previous experiments, to realize the achievement transformation.Obtain further proof of the therapeutic effect of acupuncture on glaucoma. This study will compare the therapeutic effect of acupuncture on glaucoma patients such as Hegu (LI4), Jingming (BL1), Qiuhou( Ex-HN07), Fengchi (GB20), Yiming (EX-HN14), Xingjian (LR2) with the basic drug therapy. It is further confirmed that acupuncture can not only reduce the intraocular pressure of primary glaucoma, but also alleviate or control the further damage of visual field, and make clear the special effectiveness of relevant acupoints. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1) 原发性开角型青光眼病史; 2) 年龄18岁(含)以上,80岁以下; 3) 经抗青光眼基础治疗(药物、激光、手术)后目前眼压稳定,且不高于20mmHg; 4) 全身情况稳定且可配合针刺治疗; 5) 自愿参加本研究并签署知情同意书。 

Inclusion criteria

1) History of primary open-angle glaucoma; 2) Aged 18 to 80 years old; 3) After basic anti-glaucoma treatment (drugs, lasers, surgery), the intraocular pressure is stable and not higher than 20 mmHg; 4) The whole body is stable and can be treated with acupuncture; 5) Voluntarily participate in the study and sign the informed consent. 

排除标准:

1)合并精神疾患及严重器质性疾病者; 2)妊娠、哺乳期妇女; 3)正在参加其他眼科临床试验者; 4)伴有其他器质性眼病者,如葡萄膜炎、视网膜脱离、眼底出血等。 5)剔除视力低于0.1,视野小于10°的患者。 

Exclusion criteria:

1) Patients with mental disorders and severe organic diseases; 2) Pregnant and lactating women; 3) Those who are participating in other ophthalmological clinical trials; 4) Patients with other organic ophthalmopathy, such as uveitis, retinal detachment, fundus hemorrhage, etc.; 5) Exclusion of patients with visual acuity less than 0.1 and visual field less than 10 degrees. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

试验组1

样本量:

30

Group:

experimental group 1

Sample size:

干预措施:

针刺合谷、睛明、球后穴

干预措施代码:

Intervention:

Acupuncture of Hegu, Jingming and Qiuhou Points

Intervention code:

组别:

试验组2

样本量:

30

Group:

experimental group 2

Sample size:

干预措施:

针刺风池、翳明、行间穴

干预措施代码:

Intervention:

Acupuncture of Fengchi, Yiming and Xingjian Points

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

抗青光眼药物基础治疗

干预措施代码:

Intervention:

Basic treatment of anti-glaucoma drugs

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):

上海中医大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shu Guang Hospital affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

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:

眼压

指标类型:

主要指标 

Outcome:

Intraocular pressure

Type:

Primary indicator 

指标中文名:

视野

指标类型:

主要指标 

Outcome:

View

Type:

Primary indicator 

指标中文名:

光学相干断层扫描

指标类型:

主要指标 

Outcome:

OCT

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

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 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

由统计分析人员采用SPSS 18.0软件产生随机序列

性别:

男女均可

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

Random Sequences Generated by Statistical Analysts Using SPSS 18.0 Software

Gender:

Both

盲法:

Blinding:

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):

采用临床试验公共管理平台并向公众开放查www.medresman.org

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

Use of public management platform for clinical trials and open to the public ;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):

一、病例记录表 二、电子采集和管理系统

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

1、Case Record Form 2、Electronic Data Capture

创建人:

Creater Name:

 2019-01-21
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