养血清络明目汤治疗虚火伤络型高度近视黄斑出血的临床研究

注册号:

Registration number:

ITMCTR2023000012

最近更新日期:

Date of Last Refreshed on:

2023-05-26

注册时间:

Date of Registration:

2023-05-26

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

养血清络明目汤治疗虚火伤络型高度近视黄斑出血的临床研究

Public title:

Yangxue Qingluo Mingmu Decoction for the Treatment of High Myopia Caused by Deficiency Fire and Collateral Damage Clinical study of macular hemorrhage

注册题目简写:

English Acronym:

研究课题的正式科学名称:

养血清络明目汤治疗虚火伤络型高度近视黄斑出血的临床研究

Scientific title:

Yangxue Qingluo Mingmu Decoction for the Treatment of High Myopia Caused by Deficiency Fire and Collateral Damage Clinical study of macular hemorrhage

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:

孙婉钰

研究负责人:

张红

Applicant:

WanYu-Sun

Study leader:

hong-Zhang

申请注册联系人电话:

Applicant telephone:

18801094941

研究负责人电话:

Study leader's telephone:

18611240360

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:

1025729288@qq.com

研究负责人电子邮件:

Study leader's E-mail:

zhanghong_zhbj@sina.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:

北京市石景山区鲁谷街33号中国中医科学院眼科医院

研究负责人通讯地址:

北京市石景山区鲁谷街33号中国中医科学院眼科医院

Applicant address:

Eye Hospital of China Academy of Chinese Medical Sciences, No. 33 Lugu Street, Shijingshan District, Beijing

Study leader's address:

Eye Hospital of China Academy of Chinese Medical Sciences, No. 33 Lugu Street, Shijingshan District, Beijing

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:

中国中医科学院眼科医院

Applicant's institution:

Eye Hospital,China Academy of Chinese Medical Sciences

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:

YKEC-KT-2022-003-P002

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:

中国中医科学院眼科医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Eye Hospital of the Chinese Academy of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/3/20 0:00:00

伦理委员会联系人:

张晓敏

Contact Name of the ethic committee:

xiaomin-Zhang

伦理委员会联系地址:

中国中医科学院眼科医院

Contact Address of the ethic committee:

Eye Hospital,China Academy of Chinese Medical Sciences

伦理委员会联系人电话:

Contact phone of the ethic committee:

68688877-5589

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

中国中医科学院眼科医院

Primary sponsor:

Eye Hospital of China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市石景山区鲁谷街33号

Primary sponsor's address:

No. 33 Lugu Street, Shijingshan District, Beijing

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

市(区县):

石景山区

Country:

China

Province:

Beijing

City:

Shi Jingshan

单位(医院):

中国中医科学院眼科医院

具体地址:

北京市石景山区鲁谷街33号

Institution
hospital:

Eye Hospital of China Academy of Chinese Medical Sciences

Address:

No. 33 Lugu Street, Shijingshan District, Beijing

经费或物资来源:

中国中医科学院眼科医院

Source(s) of funding:

Eye Hospital of China Academy of Chinese Medical Sciences

研究疾病:

高度近视黄斑出血

研究疾病代码:

Target disease:

Macular hemorrhage in high myopia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

1.规范性评价养血清络明目汤治疗虚火伤络型高度近视黄斑出血的临床优势 2.制定养血清络明目汤治疗虚火伤络型高度近视黄斑出血的诊疗规范

Objectives of Study:

1.Standardized evaluation of the clinical advantages of Yangxue Qingluo Mingmu Decoction in the treatment of high myopia macular hemorrhage due to deficiency of fire and collateral damage 2.Formulate the diagnostic and therapeutic criteria for Yangxue Qingluo Mingmu Decoction in the treatment of macular hemorrhage in high myopia with deficiency fire and collateral injury

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.西医诊断标准:高度近视黄斑出血按《眼科全书》我国通用屈光不正诊断标准:① 屈光度>-6.00D;② 眼底检查:高度近视眼底改变,伴黄斑区片状出血。中医诊断标准:根据《中医病证诊断疗效标准》及《中医临床诊疗术语·证候部分》为标准,符合(眼科)肝肾阴虚、虚火伤络证。主症:视物模糊,黄斑出血,头晕目眩,咽干,目涩。次症:心烦失眠,腰膝酸软,遗精盗汗。 2.眼底检查:高度近视眼底改变,伴黄斑区片状出血 3.年龄在20-60岁 4.患者签署知情同意书

Inclusion criteria

1. Diagnostic criteria of Western medicine: According to the "Complete Book of Ophthalmology", the general diagnostic criteria for refractive errors in China: ① diopter > -6.00D; ② Fundus examination: fundus changes in high myopia with patchy hemorrhage in the macular region. Diagnostic criteria of traditional Chinese medicine: According to the "Criteria for the Diagnosis and Curative Effect of Diseases and Signs in Traditional Chinese Medicine" and "Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine - Syndrome Part", it conforms to the (ophthalmology) syndrome of yin deficiency of liver and kidney, deficiency of fire and collateral damage. Main symptoms: blurred vision, macular hemorrhage, dizziness, dry throat, and astringent eyes. Secondary symptoms: restlessness, insomnia, sore waist and knees, and nocturnal sweating. 2.Fundus examination: fundus changes in high myopia with patchy hemorrhage in the macular region 3.Age: 20-60 years old 4. The patient signs the informed consent form

排除标准:

1.不符合上述诊断标准的病例 2.年龄>60岁 3.排除其他的眼部疾病,如年龄相关性黄斑变性、眼底血管条纹症、中心性渗出性视网膜病变、视网膜静脉阻塞、视网膜血管炎等 4.排除合并其他眼部损害的全身性疾病,如高血压性视网膜病变、糖尿病视网膜病变等

Exclusion criteria:

1.Cases that do not meet the above diagnostic criteria 2. Age>60 3. Exclude other eye diseases, such as age related macular degeneration, fundus vascular striae, central exudative retinopathy, retinal vein occlusion, retinal vasculitis, etc 4. Exclude systemic diseases with other eye damage, such as hypertensive retinopathy, diabetes retinopathy, etc

研究实施时间:

Study execute time:

From 2022-03-01

To      2024-05-31

征募观察对象时间:

Recruiting time:

From 2022-03-01

To      2023-11-30

干预措施:

Interventions:

组别:

伴有脉络膜新生血管组

样本量:

30

Group:

Group with choroidal neovascularization

Sample size:

干预措施:

口服养血清络明目汤

干预措施代码:

Intervention:

Oral Yangxue Qingluo Mingmu Decoction

Intervention code:

组别:

不伴脉络膜新生血管组

样本量:

30

Group:

Group without choroidal neovascularization

Sample size:

干预措施:

口服养血清络明目汤

干预措施代码:

Intervention:

Oral Yangxue Qingluo Mingmu Decoction

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

石景山区

Country:

China

Province:

Beijing

City:

Shi Jingshan

单位(医院):

中国中医科学院眼科医院

单位级别:

三级

Institution/hospital:

Eye Hospital of China Academy of Chinese Medical Sciences

Level of the institution:

three-level

测量指标:

Outcomes:

指标中文名:

中医症状

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Symptoms

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄斑中心凹厚度及容积

指标类型:

主要指标

Outcome:

Thickness and volume of macular fovea

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视力

指标类型:

主要指标

Outcome:

vision

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:

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:

正在进行

Recruiting

年龄范围:

最小 20
Min age years
最大 60
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):

非随机

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

Nonrandom

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

NO

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

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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