针刺治疗成人视神经萎缩的随机对照试验预试验

注册号:

Registration number:

AMCTR-IPR-18000232 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 9:45:06 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺治疗成人视神经萎缩的随机对照试验预试验 

Public title:

Acupuncture treatment for adult patients with optic atrophy: a pilot randomised controlled trial 

研究课题的正式科学名称:

针刺治疗成人视神经萎缩的随机对照试验预试验 

Scientific title:

Acupuncture treatment for adult patients with optic atrophy: a pilot randomised controlled trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800020053 

申请注册联系人:

刘宏伟 

研究负责人:

刘宏伟 

Applicant:

Hong-wei Liu 

Study leader:

Hong-wei Liu 

申请注册联系人电话:

Applicant telephone:

+86 15694548795 

研究负责人电话:

Study leader's telephone:

+86 15694548795 

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:

hongwei200411@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hongwei200411@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:

黑龙江省佳木斯市向阳区德祥街348号 

研究负责人通讯地址:

黑龙江省佳木斯市向阳区德祥街348号 

Applicant address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China 

Study leader's address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China 

申请注册联系人邮政编码:

Applicant postcode:

154002 

研究负责人邮政编码:

Study leader's postcode:

154002 

申请人所在单位:

佳木斯大学第一附属医院 

Applicant's institution:

First Affiliated Hospital of Jiamusi University 

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:

JMS201807 

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:

佳木斯大学附属第一医院 

Name of the ethic committee:

The ethics committee of First Affiliated Hospital of Jiamusi University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-15 

研究实施负责(组长)单位:

佳木斯大学第一附属医院 

Primary sponsor:

First Affiliated Hospital of Jiamusi University 

研究实施负责(组长)单位地址:

黑龙江省佳木斯市向阳区德祥街348号 

Primary sponsor's address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, 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):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

佳木斯大学第一附属医院

具体地址:

黑龙江省佳木斯市向阳区德祥街348号

Institution
hospital:

First Affiliated Hospital of Jiamusi University

Address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China

经费或物资来源:

佳木斯大学附属第一医院 

Source(s) of funding:

First Affiliated Hospital of Jiamusi University 

研究疾病:

视神经萎缩 

Target disease:

optic atrophy 

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:

预实验 

Study phase:

Polit 

研究目的:

本预实验的目的是评价针灸治疗成人视神经萎缩的可行性和安全性 

Objectives of Study:

This pilot randomized controlled trial will aim to assess the feasible effectiveness and safety of acupuncture for adult patients with optic atrophy (OPA). 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

入选标准将包括年龄在18至70岁之间且确诊为OPA的成年患者。所有纳入的患者都同意接受针灸治疗,并且能够提供知情同意书。 

Inclusion criteria

Adult patients aged between 18 and 70 years with a diagnosis confirmed of OPA. All of included patients will agree to receive acupuncture treatment, and will be able to provide informed consent. 

排除标准:

排除标准包括患者接受其他治疗和不愿意停止,母乳喂养,怀孕,OPA由其他条件引起,如癌症,毒性,肿瘤疾病,放射和创伤性视神经病变,参与其他临床试验,或接受在研究前2个月进行针灸或电针治疗。 

Exclusion criteria:

Patients receive other therapies and unwilling to stop, breast feeding, pregnant, OPA caused by the other conditions, such as cancer, toxicity, neoplastic disorders, radiation, and traumatic optic neuropathy, participating other clinical trials, or receiving the acupuncture, or electroacupuncture 2 months prior to the study. 

研究实施时间:

Study execute time:

From2018-12-20To 2020-06-24 

干预措施:

Interventions:

组别:

治疗组

样本量:

18

Group:

Treatment group

Sample size:

干预措施:

针刺治疗

干预措施代码:

Intervention:

Acupuncture treatment

Intervention code:

组别:

对照组

样本量:

18

Group:

Control group

Sample size:

干预措施:

假针刺

干预措施代码:

Intervention:

Sham acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

视力改善率

指标类型:

主要指标 

Outcome:

Rate of vision improvement

Type:

Primary indicator 

指标中文名:

视野改善率

指标类型:

主要指标 

Outcome:

Rate of visual field improvement

Type:

Primary indicator 

指标中文名:

增加的视野平均灵敏度

指标类型:

次要指标 

Outcome:

Increased visual field average sensitivity

Type:

Secondary indicator 

指标中文名:

模式视觉诱发电位(PVEP)幅度

指标类型:

次要指标 

Outcome:

Pattern visual evoked potential (PVEP) amplitude

Type:

Secondary indicator 

指标中文名:

缩短的PVEP延迟

指标类型:

次要指标 

Outcome:

Shortened PVEP latency

Type:

Secondary indicator 

指标中文名:

不良反应

指标类型:

附加指标 

Outcome:

Adverse reactions

Type:

Additional indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

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):

所有入组患者将以1:1的比例随机分配到治疗组(接受针灸治疗)或对照组(接受假针灸治疗)。外部统计学家将使用SAS 9.2包(SAS Institute Inc.,Cary,North Carolina,USA)操作计算机生成的随机序列。将利用块随机化来确保将相同数量的患者分配给两组。建议所有受试者在研究期间不要向结果评估员透露他们的小组分配。

性别:

男女均可

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

All enrolled patients will be randomly allocated to a treatment group (receive acupuncture treatment) or control group (receive sham acupuncture intervention) at a ratio of 1:1. An external statistician will operated the computer-generated random sequences by using SAS 9.2 package (SAS Institute Inc., Cary, North Carol

Gender:

Both

盲法:

受试者和针灸师将对针灸治疗的类型不知情。此外,所有结果评估员和数据分析师也将在整个研究过程中被掩盖。

Blinding:

The subjects and the acupuncturists will be blinded to the types of acupuncture treatment. In addition, all the outcome assessors, and data analysts will also be masked to the allocation throughout the entire study.

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):

原始数据将于2020年12月1日公开

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

Raw data will be released on December 1, 2020

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):

所有关于患者结果测量和所有其他相关数据的数据将在基线时收集,每次访问在治疗期间和随访期间。在整个研究期间,将监测和记录不良反应。包括所有治疗记录的病例报告表(CRF)将以纸质形式呈现。任何更正必须由负责的调查员签署并注明日期。所有数据将由两名独立调查员输入电子数据库,并将进行双重检查以确保准确性。此外,原始CRF及其相关表格将被保存并牢固地锁定在本研究的特殊机柜中。

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

(A standard data collection and management system include a CRF and an electronic data capture: All data regarding the participants, outcome measures, and all other relevant data will be collected at baseline, each visit during the period of treatment and follow-up. Adverse reactions will be monitored and documented through the whole study period. The case report form (CRF) including all treatment records will be presented as paper-based. Any corrections must be signed and dated by the responsible investigators. All data will be entered into the electronic database by two independent investigators, and will be double checked for the accuracy. Additionally, the original CRF and its related forms will be kept and locked securely in the special cabinets of this study.

创建人:

Creater Name:

 2018-12-14
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