今天是:2019-04-22 星期一

注射用牡荆素过敏性预试验
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注册号:

Registration number:

ChiCTR1900022541 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

注射用牡荆素过敏性预试验 

Public title:

Allergic pretest for vitexin injection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

注射用牡荆素过敏性预试验 

Scientific title:

Allergic pretest for vitexin injection 

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:

李晓亮 

研究负责人:

高蕊、李睿 

Applicant:

Xiaoliang Li 

Study leader:

Rui Gao / Rui Li 

申请注册联系人电话:

Applicant telephone:

+86 0551-65399988 

研究负责人电话:

Study leader's telephone:

+86 010-63825653 

申请注册联系人传真 :

Applicant Fax:

+86 0551-65399988 

研究负责人传真:

Study leader's fax:

+86 010-62862428 

申请注册联系人电子邮件:

Applicant E-mail:

lxl627451@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ruigao@126.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):

http://www.xyhospital.com/index.php?styleid=2 

申请注册联系人通讯地址:

安徽省合肥市高新区黄山路624号桑夏综合楼215室 

研究负责人通讯地址:

北京市海淀区西苑操场1号 

Applicant address:

Room 215, Sangxia Comprehensive Building, 624 Huangshan Road, High-tech Zone, Hefei, Anhui, China 

Study leader's address:

1 Xiyuan Playground, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

230088 

研究负责人邮政编码:

Study leader's postcode:

100091 

申请人所在单位:

合肥七星医药科技有限公司 

Applicant's institution:

Hefei Qixing Medicine Technology Co.,Ltd. 

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:

中国中医科学院西苑医院医学伦理委员会2019XL004-2 

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:

中国中医科学院西苑医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Xiyuan Hospital of China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-02 

伦理委员会联系人:

訾明杰 

Contact Name of the ethic committee:

Mingjie Zi 

伦理委员会联系地址:

北京市海淀区西苑操场1号中国中医科学院西苑医院临床药理研究所 

Contact Address of the ethic committee:

Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Playground, Haidian District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-62835646 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@126.com 

研究实施负责(组长)单位:

中国中医科学院西苑医院 

Primary sponsor:

Xiyuan Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号 

Primary sponsor's address:

1 Xiyuan Playground, Haidian District, Beijing, 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):

安徽

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

安徽九方制药有限公司

具体地址:

安徽省亳州市经济技术开发区

Institution
hospital:

Anhui Jiufang Pharmaceutical Co., Ltd.

Address:

Economic and Technological Development Zone, Bozhou City, Anhui Province

经费或物资来源:

安徽九方制药有限公司 

Source(s) of funding:

Anhui Jiufang Pharmaceutical Co., Ltd. 

研究疾病:

用于瘀血阻脉所致的胸闷胸痛;冠心病、心绞痛见上述症候者 

Target disease:

Used for chest tightness and pain caused by blood stasis; coronary heart disease, angina see above symptoms 

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:

探究注射用牡荆素对中国健康受试者皮试过敏反应,并建立科学规范的皮试方案。 

Objectives of Study:

To explore the skin test allergic reaction of vitexin for injection in Chinese healthy subjects, and establish a scientific and standardized skin test program. 

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)自愿参加临床试验、签署知情同意书并且遵从研究过程; (2)年龄在18~50岁,男女均有(女性受试者不低于1/3); (3)体重指数19~26kg/m2,男性体重不低于50kg,女性体重不低于45kg; (4)研究者根据病史、全面的体格检查、实验室检查、12导联心电图和生命体征检查判定健康的受试者; (5)纳入不少于1/4有过敏史(包括食物过敏,药物过敏,过敏性疾病等)受试者。 

Inclusion criteria

(1) Voluntary participation in clinical trials, signing informed consent form and compliance with the trial process; (2) Age between 18-50 years old, both men and women (not less than 1/3 female subjects); (3) The body mass index between 19-26 kg/m2, the male body weight is not less than 50 kg, and the female body weight is not less than 45 kg; (4) The investigator determines healthy subjects based on their medical history, comprehensive physical examination, laboratory tests, ECG, and vital signs examination; (5) Inclusion of not less than 1/4 subjects with a history of allergies (including food allergies, drug allergies, allergic diseases, etc.). 

排除标准:

(1)在研究的过程中,不能接受食物和饮料限制者; (2)曾有严重过敏史者(如过敏性休克等); (3)临床上有明显符合以下疾病的病史(包括,但不限于胃肠道,心血管,肌肉骨骼系统,内分泌系统,血液系统,精神疾病,肾脏, 肝脏,支气管,神经疾病,免疫系统,脂代谢紊乱); (4)尿液药物滥用检测阳性或有药物滥用史者,如使用过软毒品(如:摇头丸、KEN粉、麻古等)或试验前一年内使用过硬毒品(如:可卡因、海洛因、冰毒等); (5)酒精呼气测试阳性者; (6)筛选期检查以下检测任一项阳性者:HIV抗体阳性,梅毒螺旋体特异性抗体阳性,乙肝表面抗原(HBsAg)阳性,丙肝抗体阳性; (7)妊娠试验阳性(血妊娠/尿妊娠)或哺乳期妇女;所有有生育能力的男性和女性受试者不能接受试验期间自己及其伴侣采取物理避孕措施,试验结束后6个月内自己及其伴侣有生育计划,且不愿采取适当有效的避孕措施者; (8)符合下列条件之一: ① 2天内使用过β肾上腺素阻断剂者; ② 1周内使用过H1抗组胺药物、丙咪嗪、吩噻嗪、β肾上腺素等药物者; ③ 1周内使用过短效糖皮质激素类药物者; ④ 2周内局部使用过糖皮质激素类药物者; ⑤ 4周内使用过长效糖皮质激素类药物者。 (9)筛选前3个月内有住院史或者手术史; (10)筛选前3个月内参加其他的药物临床试验。 (11)研究者认为存在任何可能影响受试者提供知情同意或遵循试验方案的情况,或受试者参加试验可能影响试验结果或自身安全的其它情况。 

Exclusion criteria:

1. Those who cannot accept food and beverage restrictions during the course of the trial; 2. Those who have had a history of severe allergies (such as anaphylactic shock); 3. Those who have a clinical history that clearly meets the following diseases (including, but not limited to gastrointestinal tract, cardiovascular, musculoskeletal system, endocrine system, blood system, mental illness, kidney, liver, bronchus, neurological disease, immune system, Lipid metabolism disorder); 4. Those who have a positive urine substance abuse test or have a history of drug abuse, such as soft drugs (e.g. Ecstasy, KEN powder, Methamphetamine tablets, etc.) or hard drugs (e.g.cocaine, heroin, crystal meth, etc.) used within one year before the test; 5. Those who test positive for alcohol echalation; 6. Any of the following tests are positive in Screening test: HIV antibody positive, syphilis specific antibody positive, hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody positive; 7. Positive pregnancy test (blood pregnancy/urine pregnancy) or lactating women; all fertile male and female subjects cannot accept physical contraception for themselves and their partners during the trial period; who had a fertility plan for themselves and their partners within 6 months of the end of the trial and were unwilling to take appropriate and effective contraception; 8. One of the following conditions is met: (1) Those who have used beta adrenergic blockers within 2 days; (2) Those who have used H1 antihistamine, imipramine, phenothiazine, β-adrenalin and other drugs within 1 week; (3) Those who have used short-acting glucocorticoids within 1 week; (4) Those who have used glucocorticoids within 2 weeks; (5) Those who have used long-acting glucocorticoids within 4 weeks. 9. A history of hospitalization or surgery within the first 3 months of screening; 10. Participate in other drug clinical trials within the first 3 months of screening; (11) The investigator believes that there are any situations that may influence subject to provide informed consent form or follow the protocol, or other circumstances in which the subject's participation may affect the outcome of the trial or their own safety. 

研究实施时间:

Study execute time:

From2019-01-01To 2019-09-30 

干预措施:

Interventions:

组别:

试验1组

样本量:

30

Group:

Group 1

Sample size:

干预措施:

点刺试验

干预措施代码:

Intervention:

prick test

Intervention code:

组别:

试验2组

样本量:

30

Group:

Group 2

Sample size:

干预措施:

皮内注射

干预措施代码:

Intervention:

Intradermal injection

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):

中国中医科学院西苑医院 

单位级别:

三级甲等综合性中医医院 

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

平均风团直径比值(点刺)

指标类型:

主要指标 

Outcome:

Average wheal diameter ratio (prick test)

Type:

Primary indicator 

测量时间点:

20分钟

测量方法:

测量最长横径(D)及中点垂直径(d),并计算平均直径(S)

Measure time point of outcome:

20 min

Measure method:

Measure the longest transverse diameter (D) and the midpoint vertical diameter (d) and calculate the average diameter (S)

指标中文名:

平均风团直径(皮内注射)

指标类型:

主要指标 

Outcome:

Average wheal diameter (Intradermal injection)

Type:

Primary indicator 

测量时间点:

15分钟

测量方法:

测量最长横径(D)及中点垂直径(d),并计算平均直径(S)

Measure time point of outcome:

15 min

Measure method:

Measure the longest transverse diameter (D) and the midpoint vertical diameter (d) and calculate the average diameter (S)

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 50 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):

按签署知情同意书时间先后顺序分配筛选号,入组受试者按筛选号由小到大分配随机号。

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

The screening number was assigned according to the chronological order in which the informed consent form is signed, and the enrolled subjects were assigned random numbers according to the screening number from small to large.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验结束后6个月内在ResMan公开研究计划书、原始记录和知情同意书

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

Disclosure research plan, original record and informed consent form at ResMan within 6 months after the trial complete

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:

本次研究数据采集和管理采用EDC系统

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

EDC system was adopted for data collection and management in this trial.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-16
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