ChiCTR-TRC-12002325 版本V1.0 版本创建时间2015/8/20 20:32:23 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-12002325 

最近更新时间:

Date of Last Refreshed on:

2015/5/5 19:58:31 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

多中心、随机、双盲、安慰剂平行对照法评价白芍总苷治疗原发干燥综合征患者的有效性和安全性的临床研究 

Public title:

Multi-center, randomized, double blind, placebo controlled study of the efficacy and safety of TGP in the treatment of pSS 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

多中心、随机、双盲、安慰剂平行对照法评价白芍总苷治疗原发干燥综合征患者的有效性和安全性的临床研究 

Scientific title:

Multi-center, randomized, double blind, placebo controlled study of the efficacy and safety of TGP in the treatment of pSS 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

郝煜 

研究负责人:

王国春 

Applicant:

Hao Yu 

Study leader:

Wang Guochun 

申请注册联系人电话:

Applicant telephone:

+86 13840025163 

研究负责人电话:

Study leader's telephone:

+86 13910729602 

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:

haoyu@lansen.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

guochunwang@hotmail.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:

沈阳市和平区中兴街38-1号铁厦家园2号楼1302室 

研究负责人通讯地址:

北京市朝阳区樱花东路2号 

Applicant address:

Room1302, Building No.2, Tiexia house, 38-1 Zhongxing Street, Heping District, Shenyang 

Study leader's address:

China-Japan friendship Hospital, No.2, East Ringhua Road,ChaoYang District,Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

宁波立华制药有限公司 

Applicant's institution:

Ningbo Lihua Pharmaceutical Company Limited 

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:

2012-14 

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:

卫生部中日友好医院伦理委员会 

Name of the ethic committee:

China-Japan friendship Hospital ethics approval committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-20 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

中日友好医院风湿科 

Primary sponsor:

China-Japan friendship Hospital Department of Rheumatism 

研究实施负责(组长)单位地址:

北京市朝阳区樱花东路2号 

Primary sponsor's address:

No.2, East Ringhua Road, ChaoYang 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):

浙江

市(区县):

宁波

Country:

China

Province:

Zhejiang

City:

Ningbo

单位(医院):

宁波立华制药有限公司

具体地址:

宁波立华制药有限公司

Institution
hospital:

Ningbo Lihua Pharmaceutical Company Limited

Address:

Ningbo Lihua Pharmaceutical Company Limited

经费或物资来源:

宁波立华制药有限公司 

Source(s) of funding:

Ningbo Lihua Pharmaceutical Company Limited 

研究疾病:

原发性干燥综合征 

Target disease:

Primary Sj?gren's Syndrome, pSS 

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:

观察白芍总苷治疗原发干燥综合征患者的有效性和安全性 

Objectives of Study:

TO investigate the efficacy and safety of TGP in the treatment of pSS 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

同时满足以下条件: 1、了解试验全过程,自愿参加并签署知情同意书 2、符合2002年国际原发干燥综合征分类标准。 3、年龄≥18岁至≤75岁(至筛选之日) 4、有口、眼干症状 5、自身抗体阳性(ANA、抗SSA、抗SSB、RF之一阳性)和或血沉﹥25mm/h和或高免疫球蛋白血症 6、无严重系统受累,如严重的心包积液、肺间质病、肾小管酸中毒、萎缩性胃炎、自身免疫性肝病等。 7、入选前3个月内未参加任何药物试验者 

Inclusion criteria

Meet the following conditions:1. Understanding the whole process of the study, voluntary participation and signed the informed consent;2. Diagnosed according to Classification criteria for Sj?gren's syndrome 2002; 3. Patients aged 18 to 65 years (to the date of screening);4. Patients with dry mouth、dry eye symptoms;5. Patients with positive autoantibodies (one positive of ANA, anti-SSA, anti-SSB, RF ) or ESR> 25mm / h or high immune hypergammaglobulinemia;6. Patients with no serious systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, chronic atrophic gastritis, autoimmune liver disease;7. Not participating in any drug trials in three months before enrolled. 

排除标准:

有以下情况之一不能纳入本研究: 1、孕妇、准备妊娠或哺乳期妇女 2、唾液腺刺激流率<0.15 ml/minute 3、肝病活动期或肝功异常,ALT、AST、TBIL为正常值上限1.5倍以上者 4、肾功能损害,血肌酐≥133mmol/L(1.5mg/dL) 5、受试者血白细胞<3.0×109/L,或有明确的贫血(血红蛋白小于80g/L),或血小板<80×109/L,或有其他血液系统疾病者 6、近1年内有慢性腹泻或消化性溃疡病史者 7、未控制的严重高血压、代谢性疾病(如糖尿病)患者 8、患恶性肿瘤者 9、患急性和或慢性传染性疾病者 10、心电图检查严重心律失常者 11、对试验药物过敏者 12、有精神疾患,酗酒史,药物或其他物品滥用者 13、已诊断其他结缔组织病者 14、入选前3个月内使用过免疫抑制剂、糖皮质激素、生物制剂、腺体分泌激动剂者 15、试验期间合并使用下列药物者:免疫抑制剂、糖皮质激素、生物制剂、腺体分泌激动剂 16、具有其他各种研究者认为不能加入此临床试验的情况 

Exclusion criteria:

One of the following is not included in this study: 1. Pregnant women, ready to pregnant or lactating women; 2. Stimulated Salivary glands flow rate <0.15 ml / minute; 3. Patients with active liver disease or abnormal liver function, ALT, AST and TBIL more than 1.5 times of the upper limit of normal; 4. Patients with impaired renal function, serum creatinine ≥ 133mmol / L (1.5mg/dL); 5. Patients with white blood cells <3.0 × 109 / L, or a definite anemia (hemoglobin less than 80g / L), or platelets <80 × 109 / L, or other blood disease; 6. Patients with chronic diarrhea, or peptic ulcer nearly 1 year; 7. Patients with uncontrolled severe hypertension, metabolic diseases (eg diabetes); 8. Patients suffering from malignant tumor; 9. Patients suffering from acute and chronic infectious diseases; 10. Patients with serious arrhythmia by ECG; 11. The test drug allergy; 12. Mental disorders, history of alcohol abuse, drug or other substance abuse; 13. Patients with other connective tissue disease diagnosed; 14. Patients used immunosuppressants, corticosteroids, biological agents, glandular secretion agonists three months before enrollment; 15. During the study accompanying with the following drugs: immunosuppressive agents, glucocorticoids, biologics, glandular secretion agonists; 16. Other cases which researchers believe that can not enroll. 

研究实施时间:

Study execute time:

From2012-03-20To 2013-09-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

220

Group:

Treatment

Sample size:

干预措施:

白芍总苷胶囊

干预措施代码:

Intervention:

TGP capsules (TGP)

Intervention code:

组别:

对照组

样本量:

110

Group:

Control

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三级 

Institution
hospital:

China-Japan friendship Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽省立医院 

单位级别:

三级 

Institution
hospital:

Anhui Provincial Hospital  

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):

长海医院 

单位级别:

三级 

Institution
hospital:

Changhai Hospital  

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):

江苏省人民医院 

单位级别:

三级 

Institution
hospital:

Jiangsu Provincial People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

西京医院 

单位级别:

三级 

Institution
hospital:

Xijing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjing 

City:

 

单位(医院):

天津医科大学总医院 

单位级别:

三级 

Institution
hospital:

Tianjing Medical University General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅二院 

单位级别:

三级 

Institution
hospital:

The Second Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北省人民医院 

单位级别:

三级 

Institution
hospital:

Hebei Provincial People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

蚌埠医学院附属医院 

单位级别:

三级 

Institution
hospital:

Affiliated Hospital of Bengbu Medical College  

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 

Institution
hospital:

Shengjing Hospital of China Medical University  

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):

郑州大学第一附属医院 

单位级别:

三级 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

I欧洲抗风湿联盟干燥综合征患者报告指数评定量表

指标类型:

主要指标 

Outcome:

ESSPR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

干燥综合症疾病活动度评分

指标类型:

主要指标 

Outcome:

ESSDA

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:

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 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):

计算机软件

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

computer software

UTN(全球唯一识别码):

盲法:

1、将根据每个受试者服用药量对试验药品进行包装,包装中含有白芍总苷胶囊,或安慰剂。药物采用统一包装盒,根据试验随机编码表进行包装和分配。 2、各研究单位应设立专门地点由研究医师以外的专人主管药品发放及回收。 3、随机编码表由统计单位建立,盲底单独密封,一式两份,分别存放于临床试验负责单位和统计单位处,研究结束后进行揭盲,揭盲时由统计分析人员、主要研究者和盲底保存人员共同参加。 4、应急信件:内装盲底,为每一编码属何种类试验用药的相应说明纸条,以便发生严重不良事件时破盲用。信件用不透光纸张制成,保存于各临床试验中心主要研究者处。

Blinding:

1、Test drug packaged based on dosage of each subjects, and packaging containing Total Glucosides of Paeony capsules, or placebo. Drug unified box and packaging and distribution according to the random coding table. 2、Research units should set up a special place,and someone other than the study physicians in charge of drug delivery and recovery. 3、Random coding tables established by statistical units. Blind codes sealed separately in duplicate, and deposited in the responsible clinical trials and statistical units. After the end of the study unblinding by statistical analysts, researchers, and the staff who saved blind codees together. 4、Emergency letter: contained blind code and notes described the catogery of trial medication for breaking the blind in case of serious adverse events. Letters made with opaque paper and stored by the principal investigator of the Clinical Trials Centre.

试验完成后的统计结果:

how to cheat on my husband married affairs married men who cheat

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2012-05-30