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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
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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:

 

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:

 

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 

Applicant's institution:

Guangzhou University 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:

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 

Name of the ethic committee:

Ethics committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine  

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:

 

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:

广州中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

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 

Primary sponsor's address:

16 Airport Road, Baiyun District, Guangzhou, Guangdong, 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):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

广州市白云区机场路16号广州中医药大学第一附属医院

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

16 Airport Road, Baiyun District, Guangzhou, Guangdong, China

经费或物资来源:

2014年度中医药强省建设专项资金 

Source(s) of funding:

The 2014 special funds for the construction of strong medicine province 

研究疾病:

慢性萎缩性胃炎 

Target disease:

chronic atrophic gastritis 

研究疾病代码:

ICD-10: K29.502 

Target disease code:

ICD-10: K29.502 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

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 

Objectives of Study:

To assess the clinical efficacy and safety of Weiweiqing Granulesin the treatment of chronic atrophic gastritis  

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:

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; 

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. 

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。 

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:

From2015-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

中医组

样本量:

126

Group:

Chinese medicine group

Sample size:

干预措施:

服用胃萎清颗粒

干预措施代码:

Intervention:

take Weiweiqing Granules

Intervention code:

组别:

西医组

样本量:

126

Group:

The western medicine group

Sample size:

干预措施:

服用叶酸片

干预措施代码:

Intervention:

Taking folic acid tablets

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):

广州市 

Country:

China 

Province:

Guangdong Province 

City:

Guangzhou City 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong Province 

City:

Guangzhou City 

单位(医院):

广东省中医院 

单位级别:

三甲 

Institution
hospital:

Guangdong Provincail Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong Province 

City:

Guangzhou City 

单位(医院):

广东省第二中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Second Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong Province 

City:

Shenzhen City 

单位(医院):

深圳市中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

江门市 

Country:

China 

Province:

Guangdong Province 

City:

Jiangmen City 

单位(医院):

江门市五邑中医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangmen Wuyi Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

清远市 

Country:

China 

Province:

Guangdong Province 

City:

Qingyuan City 

单位(医院):

清远市中医院 

单位级别:

三级甲等 

Institution
hospital:

Qingyuan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

中山市 

Country:

China 

Province:

Guangdong Province 

City:

Zhongshan City 

单位(医院):

中山市中医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Traditional Chinese Medicine of Zhongshan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

东莞市 

Country:

China 

Province:

Guangdong Province 

City:

Dongguan City 

单位(医院):

东莞市中医院 

单位级别:

三级甲等 

Institution
hospital:

Dongguan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong Province 

City:

Shenzhen City 

单位(医院):

深圳市宝安区中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Bao‘an Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

肇庆市 

Country:

China 

Province:

Guangdong Province 

City:

Zhaoqing City 

单位(医院):

肇庆市中医院 

单位级别:

三级甲等 

Institution
hospital:

Zhaoqing Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

佛山市 

Country:

China 

Province:

Guangdong Province 

City:

Foshan City 

单位(医院):

佛山市顺德区均安医院 

单位级别:

二级甲等 

Institution
hospital:

Jun’an Hospital  

Level of the institution:

Second A hospital 

测量指标:

Outcomes:

指标中文名:

胃镜及病理组织学指标

指标类型:

主要指标 

Outcome:

Gastroscope and Histopathological index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清胃蛋白酶原Ⅰ、Ⅱ

指标类型:

次要指标 

Outcome:

Serum pepsinogen I and II

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要症状积分

指标类型:

次要指标 

Outcome:

The main symptom score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医生报告结局量表

指标类型:

次要指标 

Outcome:

The outcome scale reported by doctor

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者报告结局量表

指标类型:

次要指标 

Outcome:

The outcome scale reported by patient

Type:

Secondary 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:

胃黏膜

组织:

Sample Name:

gastric mucosa

Tissue:

stomach

人体标本去向

使用后保存 

说明

保存5年

Fate of sample:

Preservation after use 

Note:

Save 5 years

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

保存5年

Fate of sample:

Preservation after use 

Note:

Save 5 years

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 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):

由统计学专业人员在计算机上用SAS 9.10统计软件包产生

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:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-03-01
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