注册号: Registration number: |
ChiCTR-IOR-16008027 |
最近更新日期: Date of Last Refreshed on: |
2016-12-19 |
注册时间: Date of Registration: |
2016-03-01 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
胃萎清颗粒治疗慢性萎缩性胃炎的多中心、随机、对照临床研究 |
Public title: |
Weiweiqin granule in the treatment of chronic atrophic gastritis: a muticenter, randomized, controlled trial |
注册题目简写: |
WWQKLZLMXWSXWYDDZXSJDZLCYJ |
English Acronym: |
WGFTTOCAGAMRCCT |
研究课题的正式科学名称: |
胃萎清颗粒治疗慢性萎缩性胃炎的多中心、随机、对照临床研究 |
Scientific title: |
Weiweiqin granule in the treatment of chronic atrophic gastritis: a muticenter, randomized, controlled trial |
研究课题代号(代码): Study subject ID: |
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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: |
张长荣 |
研究负责人: |
刘凤斌 |
Applicant: |
ZHANG Chang-rong |
Study leader: |
LIU Feng-bin |
申请注册联系人电话: Applicant telephone: |
+86 15521216266 |
研究负责人电话: Study leader's telephone: |
+86 18902296111 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
1104350969@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
liufb163@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
http://www.gzhtcm.edu.cn/ |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
http://www.gztcm.com.cn/ |
申请注册联系人通讯地址: |
广州市白云区机场路12号广州中医药大学 |
研究负责人通讯地址: |
广州市白云区机场路16号广州中医药大学第一附属医院 |
Applicant address: |
12 Airport Road, Baiyun District, Guangzhou, Guangdong, China |
Study leader's address: |
16 Airport Road, Baiyun District, Guangzhou, Guangdong, China |
申请注册联系人邮政编码: Applicant postcode: |
510405 |
研究负责人邮政编码: Study leader's postcode: |
510405 |
申请人所在单位: |
广州中医药大学 |
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Applicant's institution: |
Guangzhou University of Chinese Medicine |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2015-024 |
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: |
广州中医药大学第一附属医院伦理委员会 |
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Name of the ethic committee: |
Ethics committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine |
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伦理委员会批准日期: Date of approved by ethic committee: |
2016-01-22 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
广州中医药大学第一附属医院 |
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Primary sponsor: |
The First Affiliated Hospital of Guangzhou University of Chinese Medicine |
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研究实施负责(组长)单位地址: |
广州市白云区机场路16号广州中医药大学第一附属医院 |
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Primary sponsor's address: |
16 Airport Road, Baiyun District, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
2014年度中医药强省建设专项资金 |
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Source(s) of funding: |
The 2014 special funds for the construction of strong medicine province |
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研究疾病: |
慢性萎缩性胃炎 |
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Target disease: |
chronic atrophic gastritis |
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研究疾病代码: |
ICD-10: K29.502 |
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Target disease code: |
ICD-10: K29.502 |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
评估胃萎清颗粒治疗慢性萎缩性胃炎的临床有效性及安全性 |
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Objectives of Study: |
To assess the clinical efficacy and safety of Weiweiqing Granulesin the treatment of chronic atrophic gastritis |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
需同时满足以下标准:①满足慢性萎缩性胃炎西医诊断标准;②年龄18-65周岁之间;③能够说和阅读汉语以进行交流和填写调查表;④签署知情同意书; |
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Inclusion criteria |
To simultaneously satisfy the following criteria: 1. to meet the chronic atrophic gastritis diagnostic criteria of Western medicine; 2. Aged between 18-65 years old; 3. being able to speaking and reading Chinese to communicate and to fill in the questionnaire; 4. signed the informed consent. |
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排除标准: |
满足以下任一标准即被排除:(1)存在任何可解释以上临床症状的其他疾病患者;(2)慢性食管炎、Barrett食管、胃食管反流病、消化性溃疡、胃息肉(未切除)、消化道肿物等患者;(3)内镜发现胃黏膜高级别上皮内瘤变、病理诊断恶变、胃肠道器质性疾病者;(4)有腹腔手术史患者;(5)过敏体质或对多种药物过敏者;(6)神志不清、痴呆、各种精神病、严重神经官能症及不愿意合作者;(7)具有严重的原发性心血管病变、肝脏病变、肾脏病变、血液学病变、肺脏疾病、自身免疫系统疾病、或影响其生存的严重疾病,如肿瘤或艾滋病; (8)妊娠、哺乳妇女;(9)存在认知或其他损害(如视力等)而影响参与者完成自我报告;(10)对本制剂药物组成成份过敏者;正在或4周内参加其他药物临床试验的患者;(11)调查员有充分理由认为依据参与者目前的医疗或心理状态不适合进行研究者。 |
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Exclusion criteria: |
Meet one of the following criteria were excluded: 1. there is explanation above the clinical symptoms of the patients with other diseases; 2. chronic esophagitis, Barrett esophagus and gastroesophageal reflux disease, peptic ulcer, gastric polyp (without resection), digestive tract tumor patients; 3. found that endoscopic gastric mucosa high grade intraepithelial neoplasia, pathological diagnosis, malignant gastrointestinal organic diseases; 4. patients with history of abdominal operation; 5. allergic or allergic to many medicines; 6. confusion, dementia, psychosis, neurosis and various serious unwilling to cooperate; 7. with serious the primary cardiovascular disease, liver disease, kidney disease, blood disease, lung disease, autoimmune diseases, or serious diseases affected the survival, such as cancer or aids; 8. pregnant and lactating women; 9. exist cognitive or other damage (such as vision, etc.) and impact on the participants completed self-report; 10. of the pharmaceutical composition ingredients allergies are; is or 4 weeks in other drug clinical trials of patients; 11. investigators have sufficient reason to believe that the participants according to current medical or psychological state is not suitable for researchers to study. |
研究实施时间: Study execute time: |
从From2015-01-01至To 2017-12-31 |
征募观察对象时间: Recruiting time: |
从From2016-03-01至To 2016-04-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
由统计学专业人员在计算机上用SAS 9.10统计软件包产生 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Statistical professionals using SAS 9.10 statistical software in the computer |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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): |
广州中医药大学第一附属医院 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The First Affiliated Hospital of Guangzhou University of Chinese Medicine |
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: |
广州中医药大学第一附属医院 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The First Affiliated Hospital of Guangzhou University of Chinese Medicine |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |