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基于激素依赖型溃疡性结肠炎复杂病机中药替代治疗的多中心、随机、对照临床研究
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注册号:

Registration number:

ChiCTR-IPR-15005760 

最近更新日期:

Date of Last Refreshed on:

2015-01-02 

注册时间:

Date of Registration:

2015-01-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于激素依赖型溃疡性结肠炎复杂病机中药替代治疗的多中心、随机、对照临床研究 

Public title:

Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于激素依赖型溃疡性结肠炎复杂病机中药替代治疗的多中心、随机、对照临床研究 

Scientific title:

Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study 

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:

郑凯 

研究负责人:

沈洪 

Applicant:

Kai Zheng 

Study leader:

Hong Shen 

申请注册联系人电话:

Applicant telephone:

+86 13851608387 

研究负责人电话:

Study leader's telephone:

+86 13851872859 

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:

pajo@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shenhong999@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:

中国江苏省南京市汉中路155号 

研究负责人通讯地址:

中国江苏省南京市汉中路155号 

Applicant address:

155 Hanzhong Road, Nanjing, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210029 

研究负责人邮政编码:

Study leader's postcode:

210029 

申请人所在单位:

南京中医药大学附属医院(江苏省中医院) 

Applicant's institution:

Affiliated Hospital of Nanjing 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:

2014NL-073-03 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京中医药大学附属医院(江苏省中医院)伦理委员会 

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine) 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-10-09 

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:

南京中医药大学附属医院(江苏省中医院) 

Primary sponsor:

Affiliated Hospital of Nanjing University of Chinese Medicine 

研究实施负责(组长)单位地址:

中国江苏省南京市汉中路155号 

Primary sponsor's address:

155 Hanzhong Road, Nanjing, Jiangsu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

State Administration of Traditional Chinese Medicine of the People's Republic of China 

研究疾病:

溃疡性结肠炎 

Target disease:

ulcerative colitis 

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:

I期临床试验 

Study phase:

研究目的:

制定有效、安全的难治性溃疡性结肠炎中医药治疗方案,评价中医药内外结合治疗对激素依赖型溃疡性结肠炎的临床疗效及安全性。 

Objectives of Study:

Develop effective and safety of traditional Chinese medicine treatment of refractory ulcerative colitis, evaluation of traditional Chinese medicine treatment with steroid-dependent ulcerative colitis clinical efficacy and safety. 

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)激素依赖型溃疡性结肠炎活动期及缓解期患者。 (2)中医辨证属脾肾两虚、湿热内蕴证。 (3)年龄在18~65岁之间。 (4)知情同意,自愿受试。获得知情同意书过程应符合伦理原则。 

Inclusion criteria

1. Steroid-dependent patients with ulcerative colitis; 2. The TCM differentiation is spleen kidney deficiency, damp-heat syndrome; 3. Male and female,age between 18-65; 4. Informed consent is signed. 

排除标准:

(1)菌痢、阿米巴痢、慢性血吸虫病、肠结核等感染性结肠炎及克罗恩病结肠型、缺血性肠炎、放射性肠炎患者。 (2)有严重并发症如肠梗阻、肠穿孔、中毒性巨结肠、结肠癌、直肠癌及肛门疾病患者 (3)妊娠期、哺乳期妇女,有生育计划者。 (4)具有严重的心、肺衰竭影响其生存的严重疾病, ALT>2N(N为正常值上限),Cr>正常值上限,血小板计数<50×109/L,血白细胞<3.0×109/L。 (5)法律规定的残疾患者(盲,聋,哑,智力障碍,精神障碍,肢体残疾)。 (6)怀疑或确有酒精、药物滥用病史。 (7)根据研究者的判断、具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。 (8)过敏体质,如对两种或以上药物或食物过敏史者;或已知对本药成分过敏者。 (9)正在参加其他药物临床试验的患者。 

Exclusion criteria:

1. Subject with bacillary dysentery, Amoebic dysentery, Chronic schistosomiasis, Tuberculosis of the intestines and Crohn's disease, Ischemic colitis, Radiation enteritis; 2. Subject with serious complications such as Local stenosis, Intestinal obstruction, Intestinal perforation, Toxic colon dilatation, Bleeding, Colon Cancer, Colorectal cancer; 3. Woman who is pregnant or try to conceive. Woman who is breast-feeding baby; 4. Subjects with severe primary disease of heart, and lung diseases affect living; ALT Above the twice upper limit of normal; Cr Above the upper limit of normal; PLT less than 50*10^9/L; WBC less than 3.0*10^9/L; 5. Patients with disabilities in law; 6. Suspected or indeed alcohol, drug abuse history; 7. According to judgment of the investigator, having other diseases which may reduce the likelihood of participation or complex the participation; 8. Subject who is allergic, such as who is allergic to two or more medications or knowned medications; 9. Subject who is included in other clinical trials. 

研究实施时间:

Study execute time:

From2014-06-06To 2017-03-31 

干预措施:

Interventions:

组别:

中药组

样本量:

60

Group:

TCM Group

Sample size:

干预措施:

健脾补肾,清肠敛疡配方颗粒 + 灌肠方颗粒

干预措施代码:

Intervention:

Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule

Intervention code:

组别:

西药组

样本量:

60

Group:

Control

Sample size:

干预措施:

硫唑嘌呤

干预措施代码:

Intervention:

Azathioprine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京中医药大学附属医院(江苏省中医院) 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Traditional Chinese Medicine Hospital of Guangdong Province  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三级甲等医院 

Institution
hospital:

LONGHUA Hospital Shanghai University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南中医学院第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The frist affiliated hospital of henan University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nanjing drum tower hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shengjing hospital of China medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省中医药研究院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanxi Institute of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The frist affiliated hospital of Heilongjiang University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南通市中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nantong Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

临床有效率

指标类型:

主要指标 

Outcome:

Clinical efficient rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

激素的减药、停药时间

指标类型:

主要指标 

Outcome:

Reduction time and withdraw time of steroid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床缓解率

指标类型:

主要指标 

Outcome:

Clinical remission rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内镜应答率

指标类型:

次要指标 

Outcome:

endoscopic response rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黏膜愈合率

指标类型:

次要指标 

Outcome:

endoscopic remission rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医临床证候疗效

指标类型:

次要指标 

Outcome:

TCM clinical syndrome efficacy

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

理化指标

指标类型:

次要指标 

Outcome:

Laboratory tests

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发率

指标类型:

次要指标 

Outcome:

Recurrence rate

Type:

Secondary 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:

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:

标本中文名:

尿

组织:

Sample Name:

Urine

Tissue:

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:

组织:

Sample Name:

Feces

Tissue:

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:

肠粘膜

组织:

结肠

Sample Name:

Intestinal mucosa

Tissue:

colon

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 65 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):

采用中心随机化方法。借助SAS统计分析系统产生120例受试者所接受处理(试验药和对照药)的随机安排。

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

By adopting the method of central randomization.With the help of SAS statistical analysis system to

盲法:

Blinding:

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:

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):

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:

 2015-01-02
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