ChiCTR-IPR-15006349 版本V1.1 版本创建时间2016/8/1 12:36:15 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-IPR-15006349 

最近更新时间:

Date of Last Refreshed on:

2016/8/1 12:33:52 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

参果老年感冒颗粒临床试验方案 

Public title:

Clinical trail of ShenGuo LaoNian cold granule 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

参果老年感冒颗粒临床试验方案 

Scientific title:

Clinical trail of ShenGuo LaoNian cold granule 

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:

刘雪梅 

研究负责人:

毛兵 

Applicant:

Liu Xuemei 

Study leader:

Mao Bing 

申请注册联系人电话:

Applicant telephone:

+86 13458546652 

研究负责人电话:

Study leader's telephone:

+86 18980601724 

申请注册联系人传真 :

Applicant Fax:

+86 028 85423028 

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:

492434190@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

maobing@medmail.com.cn 

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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, China 

Study leader's address:

37 Guoxuexiang, Chengdu, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, West China School of Medicine, Sichuan University 

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:

2014年临床试验(中药)审(12)号 

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:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

Clinical trials and biomedical ethics special committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-06 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都国学巷37号四川大学华西医院中西医结合科 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxuexiang, Chengdu, China

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

成都中医药大学附属医院

具体地址:

成都中医药大学附属医院

Institution
hospital:

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Address:

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

国家:

中国

省(直辖市):

吉林

市(区县):

Country:

China

Province:

Jinlin

City:

单位(医院):

长春中医药大学附属医院

具体地址:

长春中医药大学附属医院

Institution
hospital:

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Address:

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

经费或物资来源:

河北百善药业有限公司 

Source(s) of funding:

Hebei Baishan Pharmaceutical Co., Ltd. 

研究疾病:

感冒 

Target disease:

common cold 

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:

II期临床试验 

Study phase:

研究目的:

评价参果老年感冒颗粒治疗普通感冒(气虚感冒)的安全性和有效性 

Objectives of Study:

To evaluate the efficacy and safety of ShenGuo LaoNian cold granule for common cold (cold of qi-deficiency) 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合普通感冒的西医诊断标准; (2)符合中医气虚感冒的病证诊断标准; (3)患者平素畏风寒,素体为肺脾气虚,表现为最近1年以来,季节交替、气候变化时比常人易患感冒(6次/年以上);或易见疲乏,食欲不振等; (4)年龄在45-74岁之间的中老年患者; (5)发病后48小时内; (6)受试者知情同意并签署知情同意书; 

Inclusion criteria

(1) consistent with western medicine diagnosis standard of common cold; (2) consistent with diagnostic criteria of cold syndrome of qi deficiency; (3) always aversion to cold, and qi deficiency of spleen and lung, can easily catching cold when season or clinate change than ordinary people (more than 6 per year); or easily fatigue, loss of appetite, etc.; (4) elderly patients between the ages of 45-74; (5) within 48 hours of onset; (6) subjects were informed and signed the informed consent. 

排除标准:

(1)伴有急性病毒性或疱疹性咽炎和喉炎、急性咽结膜炎、急性咽扁桃体炎等疾病者; (2)合并心脑血管、肺、肾和造血系统严重原发性疾病及糖尿病或既往检测糖耐量试验异常者;心电图提示异常且有临床意义者; (3)肝功能检测值(ALT、AST)超过正常值上限1.5倍;血肌酐异常;血糖及餐后2小时血糖异常;尿蛋白>+;血白细胞小于3.0×109/L或大于10.0×109/L;和/或中性粒细胞百分率超过正常值5%; (4)发病后已使用过治疗本病的其他药物者; (5)体温>38.5℃者; (6)妊娠或准备妊娠妇女,哺乳期妇女; (7)过敏体质或对该药物已知成分过敏者; (8)精神上或法律上的残疾患者; (9)近3个月内参加其他药物临床试验者。 

Exclusion criteria:

(1) with acute viral or herpes pharyngitis and laryngitis, acute conjunctivitis pharynx, acute tonsillitis and other diseases; (2) with cardiovascular, pulmonary, renal and hematopoietic system, severe primary disease and diabetes or previous abnormal glucose tolerance test; ECG abnormal with clinical significance; (3) liver function test values (ALT, AST) more than 1.5 times the upper limit of normal value of serum creatinine; abnormal; abnormal glucose and postprandial 2 hour blood glucose; urine protein >+; white blood cell less than 3*10^9/L or more than 10*10^9/L; and / or neutrophil percentage more than 5% of normal value; (4) Had used other drugs in the treatment of this disease after the onset of the disease; (5) temperature >38.5 degree C; (6) prepare for pregnancy or pregnant women, breast-feeding women; (7) allergic to the drug or components of the drug; (8) disabled on the spirit or legally; (9) enrolled in other drug clinical trials in the past 3 months. 

研究实施时间:

Study execute time:

From2014-12-15To 2016-12-30 

干预措施:

Interventions:

组别:

高剂量组

样本量:

60

Group:

High dose group

Sample size:

干预措施:

参果老年感冒颗粒3袋/次,3次/日

干预措施代码:

Intervention:

3 bags of ShenGuo LaoNian cold granule / time, 3 times / day

Intervention code:

组别:

中剂量组

样本量:

60

Group:

Middle dose group

Sample size:

干预措施:

参果老年感冒颗粒2袋/次+安慰剂颗粒1粒/次,3次/日

干预措施代码:

Intervention:

2 bags of ShenGuo LaoNian cold granule +1 grain of placebo particles / time, 3 times / day

Intervention code:

组别:

低剂量组

样本量:

60

Group:

Low dose group

Sample size:

干预措施:

参果老年感冒颗粒1袋/次+安慰剂颗粒2粒/次,3次/日

干预措施代码:

Intervention:

1 bag of ShenGuo LaoNian cold granule +2 grain of placebo particles / time, 3 times / day

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

安慰剂颗粒3袋/次,3次/日

干预措施代码:

Intervention:

3 grain of placebo particles / time, 3 times / day

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

SiChuan 

City:

ChenDu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital of Sichuan university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

SiChuan 

City:

ChenDu 

单位(医院):

成都中医药大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

JiLin 

City:

Changchun 

单位(医院):

长春中医药大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

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 Affiliated Hospital of Tianjin University of traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

TianJin 

City:

 

单位(医院):

天津中医药大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

普通感冒症状消失时间

指标类型:

主要指标 

Outcome:

The clearance time of common cold symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

普通感冒单一症状消失时间

指标类型:

主要指标 

Outcome:

The clearance time of common cold single symptom

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第3天、第5天单一主证症状消失率

指标类型:

主要指标 

Outcome:

The single main syndrome symptoms disappearance rate on the day 3, day 5

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医主症疗效

指标类型:

主要指标 

Outcome:

The curative effect of TCM main symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效

指标类型:

主要指标 

Outcome:

Change of TCM Syndromes

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:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 74 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):

采用分层区组随机法。由第四军医大学卫生统计学教研室专业人员应用SAS统计软件PLAN过程步,根据试验组数、中心个数以及各中心病例分配数设置区组长度等参数,自动生成随机编码表,并完成药品编盲和应急信件的

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

Using stratified randomized method. The Fourth Military Medical University Health Statistics Departm

UTN(全球唯一识别码):

盲法:

当受试者发生严重的不良反应; 当受试者发生严重的并发症; 症状恶化,必须采取紧急措施者; 由于疗效原因而退出的病例,不得破盲; 紧急情况下的破盲:

Blinding:

when subjects occurred serious adverse reactions; Serious complications - when subjects; symptoms worsen, must take urgent measures; and exit because efficacy reason cases, not blind breaking; Blind breaking - in case of emergency:

试验完成后的统计结果:

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:

6M

Data collection Institution:

资料管理单位:

Not stated

Data management Institution:

Not stated

资料分析单位:

第四军医大学卫生统计学教研室

Data analysis Institution:

Health Statistics Department of The Fourth Military Medical University

注册人:

Name on Registration:

 2014-12-11