金不换健胃解毒汤治疗慢性萎缩性胃炎的临床观察和药效学机制研究

注册号:

Registration number:

ITMCTR2024000384

最近更新日期:

Date of Last Refreshed on:

2024-09-05

注册时间:

Date of Registration:

2024-09-05

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

金不换健胃解毒汤治疗慢性萎缩性胃炎的临床观察和药效学机制研究

Public title:

Clinical observation and pharmacodynamic mechanism study on the treatment of chronic atrophic gastritis with Jinbuhuan Jianweijiedu Decoction

注册题目简写:

English Acronym:

研究课题的正式科学名称:

金不换健胃解毒汤治疗慢性萎缩性胃炎的临床观察和药效学机制研究

Scientific title:

Clinical observation and pharmacodynamic mechanism study on the treatment of chronic atrophic gastritis with Jinbuhuan Jianweijiedu Decoction

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:

林智鹏

研究负责人:

蔡敏

Applicant:

LinZhipeng

Study leader:

Cai Min

申请注册联系人电话:

Applicant telephone:

13697557272

研究负责人电话:

Study leader's telephone:

13807666333

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:

2536955052@qq.com

研究负责人电子邮件:

Study leader's E-mail:

simontcm@sohu.com

申请单位网址(自愿提供):

Study leader's 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:

海南省美兰区椰海大道东19号广东省中医院海南医院

研究负责人通讯地址:

海南省美兰区椰海大道东19号广东省中医院海南医院

Applicant address:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL.No.19 East Yehaidadao Meilan District Hainan Province China

Study leader's address:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL.No.19 East Yehaidadao Meilan District Hainan Province China

申请注册联系人邮政编码:

Applicant postcode:

570200

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

广东省中医院海南医院

Applicant's institution:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

HNSZYY-2024-YJ-057

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

广东省中医院海南医院医学伦理委员会

Name of the ethic committee:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL ethics committee

伦理委员会批准日期:

Date of approved by ethic committee:

2023/3/22 0:00:00

伦理委员会联系人:

林翠

Contact Name of the ethic committee:

Lin Cui

伦理委员会联系地址:

海南省美兰区椰海大道东19号广东省中医院海南医院

Contact Address of the ethic committee:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL.No.19 East Yehaidadao Meilan District Hainan Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

0898-66210281

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lincui169@126.com

研究实施负责(组长)单位:

广东省中医院海南医院

Primary sponsor:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL

研究实施负责(组长)单位地址:

海南省美兰区椰海大道东19号广东省中医院海南医院

Primary sponsor's address:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL.No.19 East Yehaidadao Meilan District Hainan Province 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):

海南省

市(区县):

海口市

Country:

China

Province:

Hainan province

City:

Haikou city

单位(医院):

广东省中医院海南医院

具体地址:

海南省美兰区椰海大道东19号广东省中医院海南医院

Institution
hospital:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL

Address:

GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINEHAINAN HOSPITAL.No.19 East Yehaidadao Meilan District Hainan Province China

经费或物资来源:

国家自然科学基金

Source(s) of funding:

Natural Science Foundation of ChinaNSFC

研究疾病:

慢性萎缩性胃炎

研究疾病代码:

Target disease:

chronic atrophic gastritis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

我们拟开展的临床研究为金不换健胃解毒汤治疗慢性萎缩性胃炎的临床疗效观察,该研究将确证该方用于治疗慢性萎缩性胃炎并阻断胃“炎-癌”转化的作用,为挖掘名中医的黎药验方的临床效用奠定科学基础,也为院内制剂和未来新药开发积累有关的科学资料。同时该项目也为了更好地传承创新“既病防变”的中医治未病理论,使更多慢性萎缩性胃炎患者获益。

Objectives of Study:

The clinical research we are going to carry out is the clinical efficacy observation on the treatment of chronic atrophic gastritis by Jinbuhuan Jianweijiedu Decoction which will confirm the role of this formula in the treatment of chronic atrophic gastritis and blocking the transformation of gastric inflammation-cancer and lay a scientific foundation for the exploration of the clinical efficacy of the prescription of the famous traditional Chinese medicine practitioners as well as accumulating relevant scientific data for the development of the internal preparations and the future development of the new drugs. The project also aims to accumulate relevant scientific data for the development of new drugs and in-hospital preparations in the future. At the same time this project also aims to better inherit and innovate the theory of preventing disease and preventing change so that more patients with chronic atrophic gastritis can be benefited.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.符合慢性萎缩性胃炎西医诊断标准;2.符合慢性萎缩性胃炎寒热错杂证中医辨证诊断标准;3.年龄18至70周岁之间;4.能够说和阅读汉语已进行交流和填写调查表;5.自愿参加本研究并签署知情同意书

Inclusion criteria

1. meet the western medical diagnostic criteria for chronic atrophic gastritis; 2. meet the Chinese medicine diagnostic criteria for chronic atrophic gastritis with cold and heat mismatch; 3. be aged between 18 and 70 years old; 4. be able to speak and read Chinese and have communicated and filled in the questionnaire; 5. voluntarily participate in this study and sign an informed consent form

排除标准:

1.内镜发现胃黏膜内上皮高级内瘤变、病理诊断恶变、胃肠道器质性疾病者;2、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;3.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;4.妊娠、哺乳妇女;5.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;6.过敏体质或对多种药物过敏者,对观察处方药物过敏者;7.正在或4周内参加其他药物临床试验的患者;8.依据参与者目前的医疗或心理状态,调查员有充分理由认为不合适进行研究者。

Exclusion criteria:

1. endoscopic findings of advanced intraepithelial neoplasia within the gastric mucosa pathologically diagnosed malignant lesions and organic diseases of the gastrointestinal tract; 2. confusion dementia various psychiatric disorders severe neurosis and unwillingness to co-operate; 3. having severe primary cardiovascular lesions hepatic lesions renal lesions haematological lesions pulmonary diseases autoimmune system diseases or serious diseases affecting his/her survival such as tumours or AIDS 4. Pregnant or breastfeeding women; 5. Cognitive or other impairments (e.g. vision) that would interfere with the participant's ability to complete the self-report; 6. Allergic or multi-drug sensitivities or allergies to drugs prescribed for observation; 7. Patients who are participating in a clinical trial of another drug or who are participating in a clinical trial of another drug within 4 weeks of the trial; and 8. Persons who based on the participant's current medical or psychological status the investigator has good reason to believe that it is inappropriate to proceed with the study.

研究实施时间:

Study execute time:

From 2023-02-27

To      2026-02-26

征募观察对象时间:

Recruiting time:

From 2023-03-23

To      2024-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

41

Group:

Control group

Sample size:

干预措施:

叶酸片

干预措施代码:

Intervention:

Folic acid tablets

Intervention code:

组别:

治疗组

样本量:

41

Group:

treatment group

Sample size:

干预措施:

金不换健胃解毒汤

干预措施代码:

Intervention:

Jinbuhuan Jianweijiedu Decoction

Intervention code:

样本总量 Total sample size : 82

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

海南

市(区县):

海口

Country:

China

Province:

Hainan

City:

Haikou

单位(医院):

广东省中医院海南医院

单位级别:

三甲

Institution/hospital:

Hainan Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary hospital

测量指标:

Outcomes:

指标中文名:

血清炎性因子含量测定

指标类型:

次要指标

Outcome:

Measurement of serum inflammatory factor levels

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病理组织学指标

指标类型:

主要指标

Outcome:

Pathohistological indicators

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃功能血清学指标

指标类型:

次要指标

Outcome:

Serological indicators of gastric function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状积分

指标类型:

次要指标

Outcome:

Chinese Medicine 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:

胃镜检查

指标类型:

次要指标

Outcome:

gastroscopy examination

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 mucous membrane

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用随机数字表法,根据就诊顺序,将患者随机分配到试验组和对照组。

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

A random number table method was used to randomly assign patients to the test and control groups based on the order of presentation.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

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

no

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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