今天是:2019-01-16 星期三

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:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

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 drugs; (2) Those who remain in detoxification centers for more than 90 days; (3) Syndrome differentiation of TCM elements accords with Yang-Qi deficiency syndrome or Yin-Blood deficiency syndrome; (4) Those who agree to sign the informed consent of this study. 

排除标准:

(1)患有其它疾病或合并症者,如糖尿病、原发性高血压或合并其它严重原发性疾病; (2)合并肿瘤、感染、活动性炎症、免疫系统、造血系统疾病患者; (3)对所用营养食疗餐过敏或不能耐受者; (4)神志不清、痴呆、精神病患者及不合作者; (5)不同意签订本研究知情同意书者。 

Exclusion criteria:

(1) People with other diseases or complications, such as diabetes, essential hypertension or other serious primary diseases; (2) Patients with tumors, infections, active inflammation, immune system and hematopoietic system diseases; (3) Anaphylaxis or intolerance to the nutritional diet; (4) Unconsciousness, dementia, psychiatric patients and non-authors; (5) Those who do not agree to sign the informed consent of this study. 

研究实施时间:

Study execute time:

From2019-01-21To 2020-12-31 

干预措施:

Interventions:

组别:

Two groups

样本量:

312

Group:

Two groups

Sample size:

干预措施:

中医食疗vs常规食谱餐

干预措施代码:

Intervention:

Dietary Therapy of TCM versus Routine diet

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

福建省未成年人司法强制隔离戒毒所 

单位级别:

省级 

Institution
hospital:

Judicial Compulsory Separation and Rehabilitation Center for Minors in Fujian Province  

Level of the institution:

provincial level 

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):

福建省榕城司法强制隔离戒毒所 

单位级别:

省级 

Institution
hospital:

Rongcheng Judicial Compulsory Separation and Rehabilitation Center in Fujian Province  

Level of the institution:

provincial level 

测量指标:

Outcomes:

指标中文名:

中医健康状态

指标类型:

主要指标 

Outcome:

Health status of TCM

Type:

Primary indicator 

测量时间点:

干预前、干预中、干预后

测量方法:

《毒品成瘾者中医证候量表》

Measure time point of outcome:

Before, during and after intervention

Measure method:

Chinese Medicine Syndrome Scale for Drug Addicts

指标中文名:

生命质量健康状态

指标类型:

次要指标 

Outcome:

Health status of QOL

Type:

Secondary indicator 

测量时间点:

干预前、干预后

测量方法:

《苯丙胺类药物戒毒者生命质量测定量表(QLICD-ATS V1.0)》

Measure time point of outcome:

Before and after intervention

Measure method:

Quality of Life Instrument for Chronic Diseases of Amphetamine-type Stimulants Abusers under Detoxification (QLICD-ATS, V1.0)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

量表

组织:

Sample Name:

Scale

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由广州中医药大学卫生统计学陈新林教授用计算机产生的随机数字表。

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

Random number table produced by Professor Chen Xinlin of Health Statistics, Guangzhou University of Traditional Chinese Medicine.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

http://www.chictr.org.cn

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

http://www.chictr.org.cn

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:

ResMan

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

ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-11
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