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Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis
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注册号:

Registration number:

ChiCTR-IPR-16009029 

最近更新日期:

Date of Last Refreshed on:

2016-08-15 

注册时间:

Date of Registration:

2016-08-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

痹祺胶囊治疗类风湿关节炎的骨保护疗效评价研究 

Public title:

Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

痹祺胶囊治疗类风湿关节炎的骨保护疗效评价研究 

Scientific title:

Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of 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:

周颖燕 

研究负责人:

黄清春 

Applicant:

Yingyan Zhou 

Study leader:

Qingchun Huang 

申请注册联系人电话:

Applicant telephone:

+86 18819322426 

研究负责人电话:

Study leader's telephone:

+86 13922230939 

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:

zhouyy89@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

qch1963@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:

广州市番禺区大学城内环西路55号1号住院楼9楼风湿科 

研究负责人通讯地址:

广州市番禺区大学城内环西路55号1号住院楼9楼风湿科 

Applicant address:

55 West Neihuan Road, Higher Education Mega Center, Guangzhou, China 

Study leader's address:

55 West Neihuan Road, Higher Education Mega Center, Guangzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

510006 

研究负责人邮政编码:

Study leader's postcode:

510006 

申请人所在单位:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital 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:

B2016-073-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-05-30 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine 

研究实施负责(组长)单位地址:

广州市番禺区大学城内环西路55号1号住院楼9楼风湿科 

Primary sponsor's address:

55 West Neihuan Road, Higher Education Mega Center, Guangzhou, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省中医院

具体地址:

广州市番禺区大学城内环西路55号1号住院楼9楼风湿科

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

55 West Neihuan Road, Higher Education Mega Center, Guangzhou

经费或物资来源:

天津市科技计划项目技术创新引导专项基金 

Source(s) of funding:

Technological Innovation Guided Special Fund of Science and Technology Plan Projects of Tianjin Province 

研究疾病:

类风湿性关节炎 

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:

上市后药物 

Study phase:

研究目的:

以提高临床疗效为目的,本研究团队拟通过规范的随机对照大样本临床研究深入验证痹祺胶囊的骨保护优势,并基于此形成优化的中西医结合骨保护治疗方案。 

Objectives of Study:

To evaluate the bone protection effect of Biqi Capsule for treatment of RA and to ultimately improve the clinical curative effect by large-scale randomized controlled clinical research. Then form an optimization scheme for integrating bone protection therapy of Chinese medicine and Western medicine.  

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ACR/EULAR诊断标准,中医辨证为风湿痹阻证、或寒湿痹阻证、或痰瘀痹阻证、或气血亏虚证,影像学进展为Ⅰ、Ⅱ、Ⅲ级的RA患者; (2)年龄18~65岁者; (3)自愿参加试验研究,并由受试者或其家属(监护人)签署知情同意书。 

Inclusion criteria

1. RA is confirmed by 2009 ACR Criteria; Imaging results suggest Class I, II or III disease (according to the 1987 American Rheumatism Association (ARA) classification standard); CM inclusion criteria: according to the syndrome of wind and damp stagnation syndrome, or cold and damp stagnation, or phlegm and stasis stagnation, or deficiency of Qi and Blood; 2. Patients aged between 18 and 65 years; 3. Volunteered for the research and sign the informed consent. 

排除标准:

(1)不符合上述西医诊断标准的患者; (2)影像学为Ⅳ级的患者(参照1987年ARA分类标准); (3)未获得知情同意书的患者; (4)至少1个月内未停用糖皮质激素、MTX、羟氯喹、柳氮磺胺吡啶、环磷酰胺、青霉胺和金制剂等免疫抑制药或慢作用药物的患者; (5)目前正在参加或本研究前1个月内参加过其它治疗RA临床试验的患者; (6)患者本人是直接参与本试验工作的研究者; (7)有可能无法完成本研究全过程的患者; (8)不适宜用此临床试验方法进行治疗的患者; (9)合并有严重关节外病变者,如严重的肾脏淀粉样变、缩窄性心包炎、中枢神经系统血管炎等的患者; (10)合并有心血管、肺部、肝脏、肾脏、造血系统等严重疾病的患者; (11)伴有活动性胃肠道疾病的患者,以及本研究前30天内有食道或消化道溃疡的患者(既往有消化道出血病史的患者不在排除之列); (12)孕妇或哺乳期妇女的患者; (13)精神病患者; (14)研究者认为不宜进行此项临床试验者。 

Exclusion criteria:

1. Imaging results suggest Class IV disease (according to the ARA classification standard); 2. Used in the last month or using glucocorticoids, MTX, hydroxychloroquine, willow nitrogen sulfanilamide pyridine, cyclophosphamide, penicillamine and gold preparations and other immunosuppressive drugs or slow-acting drugs; 3. Participating in another clinical trial; 4. Researchers of this study; 5. Unwilling to comply with treatment or assessment regimen; 6. Unable to comply with treatment or assessment regimen; 7. Severe extra-articular diseases like renal amyloidosis, constrictive pericarditis and so on; 8. Severe comorbid conditions likely to compromise follow up evaluation; 9. Complicated with active gastrointestinal diseases or diagnosed with esophagus or digestive ulcer in the last month; 10. Women currently pregnant, or who are planning on becoming pregnant during the study period; 11. Patients with mental disease; 12. Not suitable to enter this research in the view of the researchers. 

研究实施时间:

Study execute time:

From2016-10-01To 2019-09-30 

征募观察对象时间:

Recruiting time:

From2016-11-01To 2018-09-30 

干预措施:

Interventions:

组别:

RA:试验组

样本量:

60

Group:

RA:the experimental group

Sample size:

干预措施:

甲氨喋呤片,每次10-15mg,口服,每周1次+痹祺胶囊,每次1.2g,口服,每日2次

干预措施代码:

Intervention:

MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid

Intervention code:

组别:

RA:西药对照组

样本量:

60

Group:

RA:the control group

Sample size:

干预措施:

甲氨喋呤片,每次10-15mg,口服,每周1次+来氟米特,每次10mg,口服,每日2次

干预措施代码:

Intervention:

MTX 10-15mg po qw+LEF, 10mg, po, bid

Intervention code:

组别:

OA:中医治疗组

样本量:

60

Group:

OA:The traditional Chinese group

Sample size:

干预措施:

痹祺胶囊,每次1.2g,口服,每日2次+塞来昔布胶囊 每次0.2g,口服,按需使用

干预措施代码:

Intervention:

BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed

Intervention code:

组别:

OA:西药对照组

样本量:

60

Group:

OA:The western medicine control group

Sample size:

干预措施:

骨化三淳胶丸(盖三淳),每次0.25ug,口服,每日2次++塞来昔布胶囊 每次0.2g,口服,按需使用

干预措施代码:

Intervention:

Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三甲医院 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

改良的Sharp-van der Heijde评分

指标类型:

主要指标 

Outcome:

Modified Sharp-van der Heijde

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ACR20

指标类型:

主要指标 

Outcome:

ACR20

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

Erythrocyte Sedimentation 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:

C反应蛋白

指标类型:

主要指标 

Outcome:

C Reactive Protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28关节疾病活动指数

指标类型:

主要指标 

Outcome:

DAS28

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood Routine Test

Type:

Primary indicator 

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:

主要指标 

Outcome:

Nrine Routine Test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便常规

指标类型:

主要指标 

Outcome:

Feces Rountine Test

Type:

Primary 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:

主要指标 

Outcome:

ALT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素

指标类型:

主要指标 

Outcome:

BUN

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

类风湿因子

指标类型:

主要指标 

Outcome:

Rheumatoid Factor

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基质金属蛋白酶3

指标类型:

主要指标 

Outcome:

Matrix metalloproteinase 3

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨保护素

指标类型:

主要指标 

Outcome:

Osteoprotegerin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核因子κ B受体活化因子配体

指标类型:

主要指标 

Outcome:

Receptor Activator for Nuclear Factor-κ B Ligand

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

双手DR片

指标类型:

主要指标 

Outcome:

Digital Radiography with both hands

Type:

Primary indicator 

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:

主要指标 

Outcome:

Electrocardiogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

Bone Mineral Density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DR胸片

指标类型:

主要指标 

Outcome:

Chest Digital Radiography

Type:

Primary 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:

尿液

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:

粪便

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:

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):

由广东省中医院中医药临床研究方法学重点研究室人员采用SAS V9.2 的PROC PLAN进行分层区组随机分配。

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

Stratified blocked randomization is created by using PROC PLAN (SAS V9.2) by a member from the Key Unit of Methodology in Clinical Research of Chinese Medicine.

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):

是否共享原始数据:

IPD sharing

Yes

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):

20200401,网络平台公布http://www.medresman.org

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

IPD will be shared on April 1st, 2020 by using web-bassed public database(http://www.medresman.org)

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:

SPSS 17.0

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

SPSS 17.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-15
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