电针干预新型抗精神病药利培酮、奥氮平所致代谢综合征的随机对照研究

注册号:

Registration number:

AMCTR-IPR-18000165 

注册号获得时间:

Date of releasing the registration number:

2018/6/17 12:35:52 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针干预新型抗精神病药利培酮、奥氮平所致代谢综合征的随机对照研究 

Public title:

Research on the therapeutic effect and safety of electropuncture on metabolic syndrome due to olanzapine and risperidone 

研究课题的正式科学名称:

新型抗精神病药利培酮、奥氮平所致代谢综合征的针刺干预疗效研究 

Scientific title:

Research on the therapeutic effect and safety of electropuncture on metabolic syndrome due to olanzapine and risperidone 

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:

宁艳哲 

研究负责人:

尹冬青 

Applicant:

Yanzhe Ning 

Study leader:

Dongqing Yin 

申请注册联系人电话:

Applicant telephone:

15210854881 

研究负责人电话:

Study leader's telephone:

13811005469 

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:

yanzhening0923@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yindq1123@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:

西城区安康胡同5号 

研究负责人通讯地址:

西城区安康胡同5号 

Applicant address:

No.5 Hutong, Xicheng District 

Study leader's address:

No.5 Hutong, Xicheng District 

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:

首都医科大学附属北京安定医院 

Applicant's institution:

Beijing Anding Hospital affiliated to Capital Medical 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:

2017113FS-2 

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:

首都医科大学附属北京安定医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Anding Hospital ,Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-15 

研究实施负责(组长)单位:

首都医科大学附属北京安定医院 

Primary sponsor:

Beijing Anding Hospital affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

西城区安康胡同5号 

Primary sponsor's address:

No.5 Hutong, Xicheng District 

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):

北京安定医院

具体地址:

西城区安康胡同5号

Institution
hospital:

Beijing Anding Hospital affiliated to Capital Medical University

Address:

No.5 Hutong, Xicheng District

经费或物资来源:

首都医科大学 

Source(s) of funding:

Capital Medical University 

研究疾病:

代谢综合征 

Target disease:

Capital Medical University 

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:

评价电针干预新型抗精神病药利培酮、奥氮平所致代谢综合征的疗效和安全性。 

Objectives of Study:

To evaluate efficacy and safety of electropuncture on metabolic syndrome due to olanzapine and risperidone. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.满足精神分裂症的患者;2.服用奥氮平>1个月;3.符合MS诊断标准:采用国际糖尿病联盟MS全球共识定义(2005年);4.年龄18-60周岁,性别不限;5.签署知情同意。 

Inclusion criteria

1.Hospitalized or outpatient patients diagnosed with schizophrenia according to the International Classification of Diseases (ICD-10); 2.Taking olanzapine and risperidone more than one month;3.Metabolic syndrome by the global consensus of International Diabetes Federation (2015); 4.Aged between 18 and 60, male or female; 5.The patients or their legal guardian sign an informed consent. 

排除标准:

1.有严重或不稳定的心、肝、肾、内分泌、血液等内科疾病者;2.非抗精神病药物所致的MS;3.哺乳期、妊娠或有可能在试验期间怀孕的妇女;4.对电针不能耐受者,或既往存在晕针;5.精神分裂症不平稳不能配合者。 

Exclusion criteria:

1. Diagnoses of severe cardiac, cerebral, renal or hepatic disease; 2. Metabolic syndrome caused by other reasons except antipsychotic drugs;3. Women who are breastfeeding, pregnant or may be pregnant during the trial;4. An intolerant of electroacupuncture, or history of syncope;5.Difficult to complete the inspection and treatment. 

研究实施时间:

Study execute time:

From2017-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

实验组

样本量:

15

Group:

treatment group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

electropuncture

Intervention code:

组别:

对照组

样本量:

15

Group:

control group

Sample size:

干预措施:

假电针

干预措施代码:

Intervention:

shame electropuncture

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):

北京安定医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Anding Hospital  

Level of the institution:

Three class A 

测量指标:

Outcomes:

指标中文名:

BMI

指标类型:

主要指标 

Outcome:

BMI

Type:

Primary indicator 

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood pressure

Type:

Secondary indicator 

指标中文名:

血脂

指标类型:

次要指标 

Outcome:

blood lipid

Type:

Secondary indicator 

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

fasting glucose

Type:

Secondary indicator 

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:

Recruiting status:

正在进行

Recruiting

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):

共设计观察30例MS患者,采用随机、盲法对照的临床研究方法,按1:1的比例,用SAS 统计分析系统生成随机数字表,按随机数字表,将对应的分组代码装入信封并密封(拆封 后不可复原)。按顺序号依次纳入受试者,依据信封内的分组代码,将MS患者随机分配到2组,每组15例。

性别:

男女均可

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

The random seed number and random sequence number of 30 was generated by SAS software. Randomisation numbers will be sealed in a predetermined computer-made randomisation opaque envelope. Researchers will separate the envelopes from the strain and open them according to the patients’ screening sequence

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:

即时公开/Real time access

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):

待定

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

NA

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):

研究者根据患者的原始观察记录,将数据及时、完整、正确、清晰地载入病例报告表。监查员根据GCP要求对试验进行监查。经监查员检查的病例报告表,由监查员签字后,及时送交临床试验数据管理员。数据管理员录入数据采用二次录入。在录入过程中如发现问题,采用疑问表形式及时通知监查员,要求研究者做出回答。

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

According to the original observation record, the researcher put the complete and clear data in a case report form timely. The inspector monitors the trail according to the GCP request. The case report signed by the inspector shall be sent to the clinical trial data administrator in time. Data administrator will input data separately in two times. In the process of input if the problems were found, the question forms will be sent to the researcher to answer timely .

创建人:

Creater Name:

 2018-01-20
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