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通络化湿胶囊治疗类风湿关节炎Ⅱ期临床试验
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注册号:

Registration number:

ChiCTR-TRC-12003871 

最近更新日期:

Date of Last Refreshed on:

2016-06-03 

注册时间:

Date of Registration:

2012-01-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

通络化湿胶囊治疗类风湿关节炎Ⅱ期临床试验 

Public title:

Phase II of Tong Luo Hua Shi Capsules in Rheumatoid Arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

随机、双盲、安慰剂平行对照评价通络化湿胶囊治疗类风湿关节炎活动期(风湿痹阻证)有效性和安全性的多中心临床研究 

Scientific title:

A Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid Arthritis 

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:

吴沅皞 

研究负责人:

刘维 

Applicant:

Yuanhao Wu 

Study leader:

Wei Liu 

申请注册联系人电话:

Applicant telephone:

+86 022 27432720 

研究负责人电话:

Study leader's telephone:

+86 022 27432720 

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:

doctor.wuyh@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

fengshiliuwei@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:

中国天津市南开区鞍山西道314号,天津中医药大学第一附属医院风湿免疫科 

研究负责人通讯地址:

中国天津市南开区鞍山西道314号,天津中医药大学第一附属医院风湿免疫科 

Applicant address:

314 West Anshan Road, Nankai District, Tianjin, China 

Study leader's address:

314 West Anshan Road, Nankai District, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

300193 

研究负责人邮政编码:

Study leader's postcode:

300193 

申请人所在单位:

天津中医药大学第一附属医院 

Applicant's institution:

The First Teaching Hospital of Tianjin University of Traditional 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:

TYLL2009015 

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:

天津中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Institutional Review Board of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-05-13 

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:

天津中医药大学第一附属医院 

Primary sponsor:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

中国天津市南开区鞍山西道314号 

Primary sponsor's address:

314 West Anshan Road, Nankai District, Tianjin, 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):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

兰州和盛堂制药有限公司

具体地址:

甘肃省兰州市安宁区枣林路21号

Institution
hospital:

Lanzhou Heshengtang Pharmaceutical Co.,Ltd

Address:

21 Zaolin Road, Anning District, Lanzhou

经费或物资来源:

兰州和盛堂制药有限公司 

Source(s) of funding:

Lanzhou Heshengtang Pharmaceutical Co.,Ltd 

研究疾病:

类风湿关节炎 

Target disease:

Rheumatoid arthritis 

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+II期 

Study phase:

1-2 

研究目的:

初步评价通络化湿胶囊对类风湿关节炎的安全性及有效性,并进行剂量探索为Ⅲ期给药提供临床依据。 

Objectives of Study:

To investigate the safety, and efficacy of Tong Luo Hua Shi Capsules on the participants with RA. 

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、符合类风湿关节炎诊断标准;2、符合中医痹病风湿痹阻证;3、年龄在18岁至68岁;4、初诊患者或曾经接受强的松或等剂量激素治疗的患者进入试验前剂量稳定至少30天,接受控制病情抗风湿药治疗的患者进入试验前所用药物与剂量至少稳定3个月,并且在以后的治疗中剂量不再增加,非甾体类解热镇痛药已停用30天以上。5、关节功能在Ⅰ~Ⅲ级,X线分期在Ⅰ期~Ⅲ期。6、自愿签署知情同意书。 

Inclusion criteria

The participants diagnosed with RA in accord with the American College of Rheumatology (ACR) 1987 revised criteria were enrolled. All participants had to have an ACR functional class of I, II, or III, and be in the radiographic Staging of I, II, or III. Disease-modifying antirheumatic drugs (DMARDs) and immunosuppressants were discontinued at least 30 days before the initial administration. Participants receiving a stable dosing regimen of the same glucocorticoids e.g. prednisolone (10 mg daily maximum) prior to entering the study were allowed. In addition, written informed consent was obtained from each participants before enrollment. 

排除标准:

1、重叠其他风湿病如系统性红斑狼疮、干燥综合征、严重的膝骨关节炎等者;2、过敏体质(对两种以上物质过敏)或对本药成分过敏者;3、妊娠或哺乳期患者、精神病患者等;4、4周内参加过其他药物临床试验的患者;5、合并心、脑、肝(AST、ALT高于正常值1.5倍)、肾(Cr高于正常值上限)和造血系统等严重疾病者;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或情况,如工作环境经常变动、生活环境不稳定等易造成失访的情况。 

Exclusion criteria:

Pregnant women, nursing women, and women of child bearing potential not using an effective method of contraception were excluded. Participants were also excluded if they had severe disability, a history of a serious allergic reaction, any other concurrent rheumatic disease such as systemic lupus erythematosus, sjogren's syndrome, severe osteoarthritis, or significant cardiac, blood, respiratory, neurological, endocrine, renal, hepatic, gastrointestinal, or psychotic disease, or an active intercurrent infection. Participants in another clinical study within 4 months of study entrywere excluded as well. Moreover, the participants suspected of having a history of alcohol or drug abuse, and in any condition or situation that may interfere with the participation were excluded. 

研究实施时间:

Study execute time:

From2009-05-01To 2011-06-01 

干预措施:

Interventions:

组别:

A

样本量:

60

Group:

A

Sample size:

干预措施:

通络化湿胶囊2粒,必要时口服扶他林片、来氟米特片

干预措施代码:

Intervention:

2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary

Intervention code:

组别:

B

样本量:

60

Group:

B

Sample size:

干预措施:

通络化湿胶囊3粒,必要时口服扶他林片、来氟米特片

干预措施代码:

Intervention:

3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary

Intervention code:

组别:

C

样本量:

60

Group:

C

Sample size:

干预措施:

通络化湿胶囊4粒,必要时口服扶他林片、来氟米特片

干预措施代码:

Intervention:

4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary

Intervention code:

组别:

D

样本量:

60

Group:

D

Sample size:

干预措施:

安慰剂4粒

干预措施代码:

Intervention:

4 pieces placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 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):

辽宁中医药大学附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

乌鲁木齐 

Country:

China 

Province:

Xinjiang Uyghur Autonomous Region 

City:

Urumqi 

单位(医院):

新疆维吾尔自治区中医医院 

单位级别:

三甲 

Institution
hospital:

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省中医院(光谷院区) 

单位级别:

三甲 

Institution
hospital:

Hubei Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

青海 

市(区县):

西宁 

Country:

China 

Province:

Qinghai 

City:

Xining 

单位(医院):

青海省藏医院 

单位级别:

三甲 

Institution
hospital:

Tibetan Medicine Hospital of Qinghai Province  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

类风湿关节炎疾病活动性核心测量指标

指标类型:

主要指标 

Outcome:

American College of Rheumatology (ACR20\50\70) core criteria

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

相关症状体征:关节压痛数、关节肿胀数,晨僵时间、双手平均握力、疼痛VAS评分、关节功能)。

指标类型:

次要指标 

Outcome:

RA related symptoms: Number of tender and swollen joints assessed using 28-joint counts, pain assess

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:

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 68 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):

专业统计人员用SAS软件产生随机序列

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

Using random number generator of SAS

盲法:

双盲

Blinding:

Double-blind

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-01-01
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