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Clinical research on Qijiaoshengbai Capsules in treatment of leucopenia (deficiency of both qi and blood syndrome)
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注册号:

Registration number:

ChiCTR-IPR-15006758 

最近更新日期:

Date of Last Refreshed on:

2015-07-16 

注册时间:

Date of Registration:

2015-07-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

芪胶升白胶囊治疗白细胞减少症(气血两虚证)临床研究 

Public title:

Clinical research on Qijiaoshengbai Capsules in treatment of leucopenia (deficiency of both qi and blood syndrome) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芪胶升白胶囊治疗白细胞减少症(气血两虚证)临床研究 

Scientific title:

Clinical research on Qijiaoshengbai Capsules in treatment of leucopenia (deficiency of both qi and blood syndrome) 

研究课题代号(代码):

Study subject ID:

2014ZX09301308007 

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:

侯丽 

研究负责人:

侯丽 

Applicant:

Li Hou 

Study leader:

Li Hou 

申请注册联系人电话:

Applicant telephone:

+86 13488695608 

研究负责人电话:

Study leader's telephone:

+86 13488695608 

申请注册联系人传真 :

Applicant Fax:

+86 010-84013127 

研究负责人传真:

Study leader's fax:

+86 010-84013127 

申请注册联系人电子邮件:

Applicant E-mail:

houli1203@126.com 

研究负责人电子邮件:

Study leader's E-mail:

houli1203@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.dzmyy.com.cn 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.dzmyy.com.cn 

申请注册联系人通讯地址:

北京市东城区海运仓5号 

研究负责人通讯地址:

北京市东城区海运仓5号 

Applicant address:

5 Haiyuncang, Dongcheng District, Beijing 

Study leader's address:

5 Haiyuncang, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

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:

ECPJ-BDY-2015-08 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-06-29 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市东城区海运仓5号 

Primary sponsor's address:

5 Haiyuncang, Dongcheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

贵州

市(区县):

贵阳

Country:

China

Province:

Guizhou

City:

Guiyang

单位(医院):

贵阳德昌祥药业有限公司

具体地址:

贵州省贵阳市金阳高新技术园区都匀路109号

Institution
hospital:

Guiyang DeChangXiang Pharmaceutical Co., Ltd

Address:

109 Duyun Road, Jinyang hi-tech Zone, Guiyang

经费或物资来源:

国家科技重大专项 

Source(s) of funding:

National Science and Technology Major Project 

研究疾病:

白细胞减少症(气血两虚证) 

Target disease:

Leucopenia (deficiency of both qi and blood syndrome) 

研究疾病代码:

D70.X01 

Target disease code:

D70.X01 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价芪胶升白胶囊治疗白细胞减少症(气血两虚证)临床疗效与安全性 

Objectives of Study:

To observe the clinical efficacy,safety of Qijiaoshengbai capsule in leucopenia (deficiency of both qi and blood syndrome) 

药物成份或治疗方案详述:

大枣、阿胶、血人参、淫羊藿、苦参、黄芪、当归 

Description for medicine or protocol of treatment in detail:

Chinese-date,Donkey-hide gelatin,Indigofera stachyodes Lindl's root,Epimedium,kuh-seng,Astagalus membranaceus,Chinese angelica 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

同时具备下列5项:①符合白细胞减少症诊断标准,且白细胞计数<4.0×109/L,>2.0×109/L,或有中性粒细胞<2.0×109/L,>0.5×109/L;②年龄18~75岁之间,性别不限;③中医辨证为气血两虚证;④无合并其他严重疾病(心、肝、肾、血液病)病史;⑤自愿接受临床研究,并签署知情同意书。 

Inclusion criteria

Have all of the following 5 criteria: 1. Conform to the diagnosis of leucopenia and 2.0*10^9/L

排除标准:

具备下列条件之一者:①不符合以上纳入标准;②因感染或免疫疾病引起的白细胞减少;③脾功能亢进患者,或恶性肿瘤放化疗中患者;④妊娠或哺乳期妇女;⑤精神病患者;⑥既往治疗史中发现用药的依从性差。 

Exclusion criteria:

Have any one of the following: 1. Not comply with the above inclusion criteria; 2. Leukopenia caused by infection or immune diseases; 3. Patients with hypersplenism, or patients with malignant tumor in radiotherapy or chemotherapy; 4. Pregnant or lactating women; 5. Mental patients; 6. Unable to follow the prescription in previous treatment. 

研究实施时间:

Study execute time:

From2015-01-24To 2016-06-30 

征募观察对象时间:

Recruiting time:

From2015-07-30To 2016-03-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

72

Group:

Treatment group

Sample size:

干预措施:

芪胶升白胶囊

干预措施代码:

Intervention:

Qijiaoshengbai Capsules

Intervention code:

组别:

对照组

样本量:

72

Group:

Control group

Sample size:

干预措施:

安多霖胶囊

干预措施代码:

Intervention:

Anduolin capsules

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(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital Affiliated to Liaoning University of Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

湖南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Hunan University of Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences  

Level of the institution:

Xiyuan Hospital of China Academy of Chinese Medical Sciences 

国家:

中国 

省(直辖市):

广西 

市(区县):

南宁 

Country:

China 

Province:

Guangxi 

City:

Nanning 

单位(医院):

广西中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangxi University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Hospital Affiliated to Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

Pudong New District 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西省中医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Province Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhejiang Chinese University  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

白细胞

指标类型:

主要指标 

Outcome:

WBC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中性粒细胞

指标类型:

主要指标 

Outcome:

NEUT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候

指标类型:

次要指标 

Outcome:

TCM syndrome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

副作用指标 

Outcome:

ALT

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷草转氨酶

指标类型:

副作用指标 

Outcome:

AST

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆红素

指标类型:

副作用指标 

Outcome:

TBIL

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

直接胆红素

指标类型:

副作用指标 

Outcome:

DBIL

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

副作用指标 

Outcome:

Cr

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素氮

指标类型:

副作用指标 

Outcome:

BUN

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞

指标类型:

副作用指标 

Outcome:

RBC

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

副作用指标 

Outcome:

HGB

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板

指标类型:

副作用指标 

Outcome:

PLT

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

Routine urine test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

副作用指标 

Outcome:

Stool routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

ECG

Type:

Adverse events 

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:

标本中文名:

静脉血

组织:

静脉

Sample Name:

Venous blood

Tissue:

Vein

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

膀胱

Sample Name:

Urine

Tissue:

Bladder

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

大便

组织:

肠道

Sample Name:

Stool

Tissue:

Intestinal tract

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

采用分段随机化方法,由统计人员应用SAS统计软件PROC PLAN程序产生随机序列

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

Using block randomization method,generate a random sequence by the statistics personnel

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-07-15
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