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可食园艺疗法对精神分裂症患者锥体外系副反应的疗愈作用
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注册号:

Registration number:

ChiCTR2000039589 

最近更新日期:

Date of Last Refreshed on:

2020-11-02 

注册时间:

Date of Registration:

2020-11-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

可食园艺疗法对精神分裂症患者锥体外系副反应的疗愈作用 

Public title:

Therapeutic effect of edible horticultural therapy on extrapyramidal side effects in patients with schizophrenia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

可食园艺疗法对精神分裂症患者锥体外系副反应的疗愈作用 

Scientific title:

Therapeutic effect of edible horticultural therapy on extrapyramidal side effects in patients with schizophrenia 

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:

周帆 

研究负责人:

贺慧 

Applicant:

Fan Zhou 

Study leader:

Hui He 

申请注册联系人电话:

Applicant telephone:

+86 18696116741 

研究负责人电话:

Study leader's telephone:

+86 15972948916 

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:

49306849@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

hehui66@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:

湖北省武汉市青山区武东路安康巷46号武东医院精神科 

研究负责人通讯地址:

武汉市洪山区珞瑜东路 1037 号华中科技大学南四楼6号信箱 

Applicant address:

46 Ankang Lane, Wudong Street, Qingshan District, Wuhan, Hubei, China 

Study leader's address:

1037 Luoyu Road, Hongshan District, Wuhan, Hubei, 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:

武汉市武东医院 

Applicant's institution:

Wuhan Wudong Hospital  

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:

20200501 

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:

武汉市武东医院伦理委员会 

Name of the ethic committee:

Ethics committee of wuhan wudong hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-05 

伦理委员会联系人:

戢秋明 

Contact Name of the ethic committee:

Qiu Ming Ji 

伦理委员会联系地址:

湖北省武汉市青山区武东路安康巷46号武东医院 

Contact Address of the ethic committee:

Wuhan Wudong Hospital, 46 Ankang Lane, Wudong Street, Qingshan District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

华中科技大学建筑与城市规划学院 

Primary sponsor:

School of Architecture and Urban Planning, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

武汉市洪山区珞瑜东路 1037 号华中科技大学南四楼 

Primary sponsor's address:

School of Architecture and Urban Planning, Huazhong University of Science and Technology, 1037 Luoyu Road, Hongshan District, Wuhan, Hubei, 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市武东医院

具体地址:

湖北省武汉市青山区武东路安康巷46号

Institution
hospital:

Wuhan Wudong Hospital

Address:

46 Ankang Lane, Wudong Street, Qingshan District

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

精神分裂症 

Target disease:

schizophrenia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本文旨在研究探索可食园艺疗法对精神分裂症患者锥体外系副作用的疗愈作用,以期提高患者生活质量及服药依从性。 

Objectives of Study:

The purpose of this study was to explore the therapeutic effect of edible horticultural therapy on extrapyramidal side effects in patients with schizophrenia in order to improve the quality of life and medication compliance. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

纳入标准为女性,患有精神分裂症,符合《国际疾病分类》第10版(ICD-10)修订版诊断标准,病程> 3年,入院时间> 2年,使用抗精神病药物, 锥体外系反应量表 (RSESE) 评分≥2分。能够口头交流和表达自己,并且具有一定程度的运动能力。 

Inclusion criteria

Female with schizophrenia, meeting the revised diagnostic criteria of the International Classification of Diseases, 10th Edition (ICD-10), course of disease >3 years, the extrapyramidal Response Scale (RSESE) score>=2, and was able to communicate and express themselves orally, and had a certain degree of motor ability 

排除标准:

具有帕金森病家族史,自杀和/或自残行为,沟通困难,花粉/植物过敏和严重身体疾病的患者被排除在外 

Exclusion criteria:

Patients with a family history of Parkinson's disease, suicidal and/or self-destructive behavior, communication difficulties, pollen/plant allergies, and severe physical illness were excluded 

研究实施时间:

Study execute time:

From2020-05-06To 2021-05-06 

征募观察对象时间:

Recruiting time:

From2020-05-06To 2020-05-15 

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

none

Intervention code:

组别:

实验组

样本量:

20

Group:

experimental grooup

Sample size:

干预措施:

可食园艺疗法

干预措施代码:

Intervention:

Edible horticultural therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市武东医院 

单位级别:

三级医院 

Institution
hospital:

Wuhan Wudong hospital  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

阳性和阴性症状评定量表

指标类型:

主要指标 

Outcome:

Positive and Negative Syndrome Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

锥体外系副反应量表

指标类型:

主要指标 

Outcome:

Rating Scale for Extrapyramidal Side Effects

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

采用随机数字表法对所有患者进行分组

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

All patients were assigned by random number table method

盲法:

未说明

Blinding:

Not stated

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):

以表格形式上传

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

Upload as a table

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:

以表格形式管理

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

Manage in a tabular form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-11-02
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