针刺治疗中重度干眼的随机对照试验研究

注册号:

Registration number:

AMCTR-IOR-18000162 

注册号获得时间:

Date of releasing the registration number:

2019/9/28 22:29:19 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺治疗中重度干眼的随机对照试验研究 

Public title:

Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial 

研究课题的正式科学名称:

针刺治疗中重度干眼的随机对照试验研究 

Scientific title:

Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800015831 

申请注册联系人:

张雪 

研究负责人:

张雪 

Applicant:

Xue Zhang 

Study leader:

Xue Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13260476371 

研究负责人电话:

Study leader's telephone:

+86 13260476371 

申请注册联系人传真 :

Applicant Fax:

+86 010-60283714 

研究负责人传真:

Study leader's fax:

+86 010-60283714 

申请注册联系人电子邮件:

Applicant E-mail:

zhangxueresume@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangxueresume@aliyun.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://gamhnq.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://gamhnq.cn/ 

申请注册联系人通讯地址:

北京市大兴区黄村镇兴丰大街138号 

研究负责人通讯地址:

北京市大兴区黄村镇兴丰大街138号 

Applicant address:

138 Xingfeng Street, Huangcun Town, Daxing District, Beijing, China 

Study leader's address:

138 Xingfeng Street, Huangcun Town, Daxing District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

102618 

研究负责人邮政编码:

Study leader's postcode:

102618 

申请人所在单位:

中国中医科学院广安门医院南区 

Applicant's institution:

South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences 

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:

2018-012-KY-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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guang’anmen Hospital of China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-04-19 

研究实施负责(组长)单位:

中国中医科学院广安门医院南区 

Primary sponsor:

South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市大兴区黄村镇兴丰大街138号 

Primary sponsor's address:

138 Xingfeng Street, Huangcun Town, Daxing 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):

中国中医科学院广安门医院南区

具体地址:

北京市大兴区黄村镇兴丰大街138号

Institution
hospital:

South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Address:

138 Xingfeng Street, Huangcun Town, Daxing District, Beijing, China

经费或物资来源:

广安门医院南区所级科研基金 

Source(s) of funding:

South Area of Guang’anmen Hospital scientific fund 

研究疾病:

干眼 

Target disease:

Dry eye disease 

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:

主要目的是评价针刺治疗中重度干眼的疗效和安全性,以及评价针刺疗法的接受性。 

Objectives of Study:

The main objectives of study is to evaluate the efficacy and safety of acupuncture in the treatment of moderate to severe dry eyes, and to evaluate the acceptability of acupuncture. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1) 年龄大于18岁小于60岁者; (2) 符合干眼的诊断标准; (3) 选择双眼中病情较重的单眼进行结局观察;(首先参照SIT结果进行筛选,如果双眼相同,依次进行BUT、OGS、OSDI评分、VAS评分、筛选,如果双眼都相同,取右眼进行试验) (4) 同意遵守研究方案,并按方案要求完成研究,能配合检查及治疗,能理解和配合填写调查问卷、量表,签署知情同意书,自愿参加本项研究者。 

Inclusion criteria

1. individuals aged more than 18 years old and less than 60 years old; 2. participants meeting the diagnostic criteria of DED. The criteria of moderate to severe DED is based on the following ophthalmologic tests: a Schirmer I test (with the application of cocaine, a local anesthetic) value ≥ 3 mm/5 minutes and ≤ 9mm/5 minutes, a tear break-up time (TBUT) ≤ 9 seconds and CFS ≥ 1. These ophthalmologic tests will be performed by the ophthalmologists who don't know the results of random allocation; 3. Only the single eye with more severe scores or symptoms is selected to observe the outcome; and 4. participants who can complete the study, treatment, and assessments. 

排除标准:

(1) 屈光、白内障等手术后3个月内; (2) 患有其他眼部疾病者,如泪道阻塞,其他结膜、角膜病变者; (3) 患有干燥综合征、类风湿性关节炎等免疫系统疾病者; (4) 心、肝、肾功能异常者,或造血系统疾病、精神疾病,或者对于某些特殊疾病,电针可能是不合适的或不安全的; (5) 受试者在最近1周内接受针刺治疗; (6) 妇女怀孕的; (7) 正参与其他临床试验; (8) 对针刺严重的恐惧。 

Exclusion criteria:

1. participants who have undergone surgery for DED within 3 months; 2. participants with other ocular diseases (e.g., lacrimal duct obstruction, other conjunctiva and keratopathy) or immune system diseases (e.g., Sjogren syndrome and rheumatoid arthritis); 3. participantswith immune system diseases such as Sjogren syndrome and rheumatoid arthritis 4. participants with cardiovascular, liver, kidney, or hematopoietic system diseases, mental health disorders, or cancer for whom acupuncture may be inappropriate or unsafe; 5. participants who have received acupuncture within the past week; 6. women who are pregnant or lactating; 7. participants who are participating in other clinical trials; and 8. participants with a pacemaker, metal allergy, or severe fear of needles. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

60

Group:

Acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

玻璃酸钠滴眼液

干预措施代码:

Intervention:

Sodium hyaluronate eye drops

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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

广安门医院南区 

单位级别:

三级甲等 

Institution
hospital:

South Area of Guang'anmen Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

泪液分泌量

指标类型:

主要指标 

Outcome:

the Schirmer-I test

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

泪液

组织:

Sample Name:

Tears

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 60 years

随机方法(请说明由何人用什么方法产生随机序列):

随机由广安门医院药品临床试验办公室使用随机数字生成器生成。

性别:

男女均可

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

The randomization is performed by the Drug Clinical Trial Office affiliated with Guang’anmen Hospital using a computerized random number generator.

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):

2020.5.30;http://www.gamhnq.cn/

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

2020.5.30;http://www.gamhnq.cn/

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):

病例记录表扫描件

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

Case Record Form scanning copy

创建人:

Creater Name:

 2018-04-25
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