今天是:2019-06-24 星期一

中医食疗对戒毒人员健康状态改善的研究
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注册号:

Registration number:

ChiCTR1900020649 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医食疗对戒毒人员健康状态改善的研究 

Public title:

Study for the Improvement of Health Status of Detoxification Personnel by Dietary Therapy of TCM 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医食疗对戒毒人员健康状态改善的研究 

Scientific title:

Detoxification of Drugs by Dietary Therapy of Traditional Chinese Medicine 

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:

张立万 

研究负责人:

张立万 

Applicant:

Liwan Zhang 

Study leader:

Liwan Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13305910191 

研究负责人电话:

Study leader's telephone:

+86 13305910191 

申请注册联系人传真 :

Applicant Fax:

+86 0591 88201820 

研究负责人传真:

Study leader's fax:

+86 0591 88201820 

申请注册联系人电子邮件:

Applicant E-mail:

27402586@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

27402586@qq.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:

福州市鼓楼区八一七中路41号新兴大厦1207 

研究负责人通讯地址:

福州市鼓楼区八一七中路41号新兴大厦1207 

Applicant address:

Room 1207, Xinxing Building, 41 Middle 817th Road, Gulou District, Fuzhou, Fujian, China 

Study leader's address:

Room 1207, Xinxing Building, 41 Middle 817th Road, Gulou District, Fuzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

350001 

研究负责人邮政编码:

Study leader's postcode:

350001 

申请人所在单位:

福建省健康管理师协会 

Applicant's institution:

Health Manager Association of Fujian Province 

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:

20170904001 

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:

杭州师范大学科学研究伦理委员会 

Name of the ethic committee:

Scientific Research Ethics Committee of Hangzhou Normal University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-04 

伦理委员会联系人:

张遵义 

Contact Name of the ethic committee:

Zunyi Zhang 

伦理委员会联系地址:

杭州市余杭区仓前街道海曙路58号 

Contact Address of the ethic committee:

58 Haishu Road, Cangqian Street, Yuhang District, Hangzhou, Zhejiang, 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:

福州协医堂健康管理有限公司 

Primary sponsor:

Fuzhou Xieyitang Health Management Co., Ltd. 

研究实施负责(组长)单位地址:

福州市鼓楼区八一七中路41号新兴大厦1207  

Primary sponsor's address:

Room 1207, Xinxing Building, 41 Middle 817th Road, Gulou District, Fuzhou, Fujian, 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):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福州协医堂健康管理有限公司

具体地址:

福州市鼓楼区八一七中路41号新兴大厦1207

Institution
hospital:

Fuzhou Xieyitang Health Management Co., Ltd.

Address:

Room 1207, Xinxing Building, 41 Middle 817th Road, Gulou District, Fuzhou, Fujian, China

经费或物资来源:

福建省未成年人司法强制隔离戒毒所、福建省榕城司法强制隔离戒毒所 

Source(s) of funding:

Fujian Judicial Compulsory Separation and Rehabilitation Center for Minors, Rongcheng Judicial Compulsory Separation and Rehabilitation Center in Fujian Province 

研究疾病:

药物成瘾 

Target disease:

Drug addiction 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

根据中医辨证施膳原理,给予阳气虚型、阴血虚型康复期强制隔离戒毒人员中医食疗干预,观察干预前后中医健康状态、生命质量健康状态等指标的变化,依此评价中医食疗对戒毒人员健康状态的改善。 

Objectives of Study:

According to the principle of dietary treatment based on syndrome differentiation in TCM, the detoxification personnel of compulsory isolation witn Yang-Qi deficiency or Yin-Blood deficiency in rehabilitation period are given intervention by dietary therapy of TCM, and the changes of TCM health status, QOL health status before and after the intervention are observed to evaluate the improvement of dietary therapy of TCM on the health status of detoxification personnel. 

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:

(1)吸食苯丙胺类药物的强制隔离戒毒人员; (2)剩余在戒毒所时间90天以上者; (3)中医证素辨证符合阳气虚证或阴血虚证; (4)同意签订本研究知情同意书者。 

Inclusion criteria

(1) Detoxification personnel of compulsory isolation who take amphetamine dru