ChiCTR2400082367 版本V1.0 版本创建时间2024/03/27 14:40:50 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：

ChiCTR2400082367 

最近更新日期：

Date of Last Refreshed on：

2024-03-27 14:40:46 

注册时间：

Date of Registration：

2024-03-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

温胃散积膏治疗慢性萎缩性胃炎伴肠化生的真实世界研究

Public title：

A real-world study on the treatment of chronic atrophic gastritis with intestinal metaplasia using Wen Wei San Ji Gao

注册题目简写：

English Acronym：

研究课题的正式科学名称：

温胃散积膏治疗慢性萎缩性胃炎伴肠化生的真实世界研究

Scientific title：

A real-world study on the treatment of chronic atrophic gastritis with intestinal metaplasia using Wen Wei San Ji Gao

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：

王维 

研究负责人：

闻新丽 

Applicant：

Wang Wei 

Study leader：

Wen Xinli 

申请注册联系人电话：

Applicant telephone：

+86 139 9206 5196

研究负责人电话：

Study leader's telephone：

+86 155 9182 1695

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：

wangwei@ebm.tech

研究负责人电子邮件：

Study leader's E-mail：

wxli696@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)：

申请注册联系人通讯地址：

陕西省西安市莲湖区恒天财智大厦17A4

研究负责人通讯地址：

陕西省西安市莲湖区西华门4号

Applicant address：

17A4, Hengtian Caizhi Building, Lianhu District, Xi'an, Shaanxi

Study leader's address：

4 Xihuamen, Lianhu District, Xi'an, Shaanxi

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

陕西省中医医院

Applicant's institution：

Shaanxi Provincial Traditional Chinese Medicine Hospital

研究负责人所在单位：

陕西省中医医院

Affiliation of the Leader：

Shaanxi Provincial Traditional Chinese Medicine Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2024)伦审第(06)号

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：

陕西省中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shaanxi Provincial Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-21 00:00:00

伦理委员会联系人：

史亮

Contact Name of the ethic committee：

Shi Liang

伦理委员会联系地址：

陕西省西安市莲湖区西华门4号

Contact Address of the ethic committee：

4 Xihuamen, Lianhu District, Xi'an, Shaanxi

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 29 8725 1691

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：

陕西省中医医院

Primary sponsor：

Shaanxi Provincial Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

陕西省西安市莲湖区西华门4号

Primary sponsor's address：

4 Xihuamen, Lianhu District, Xi'an, Shaanxi

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

陕西省中医医院

具体地址：

陕西省西安市莲湖区西华门4号

Institution
hospital：

Shaanxi Provincial Traditional Chinese Medicine Hospital

Address：

4 Xihuamen, Lianhu District, Xi'an, Shaanxi

经费或物资来源：

研究者自筹

Source(s) of funding：

Researchers self financing

Target disease：

Chronic atrophic gastritis with intestinal metaplasia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

以陕西省中医医院脾胃病二科为承担科室，共收集72例慢性萎缩性胃炎伴肠化生患者，通过真实世界研究，评价温胃散积膏治疗慢性萎缩性胃炎伴肠化生（脾胃虚弱并胃络瘀阻证）的临床疗效和安全性，为该处方的研究与开发提供证据支持。  

Objectives of Study：

A total of 72 patients with chronic atrophic gastritis accompanied by intestinal metaplasia were collected from the Department of Spleen and Stomach Disease, Shaanxi Provincial Hospital of Traditional Chinese Medicine. Through real-world research, the clinical efficacy and safety of Wenwei San Ji Gao in the treatment of chronic atrophic gastritis accompanied by intestinal metaplasia (spleen stomach weakness and gastric meridian stasis syndrome) were evaluated, providing evidence support for the research and development of this prescription.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

具备以下所有项目者，方可纳入： （1）西医诊断符合慢性萎缩性胃炎伴肠化生的患者； （2）中医辨证属脾胃虚弱并胃络瘀阻证者； （3）Hp阴性者或伴有Hp感染者经根除治疗1个月后复查转阴者； （4）年龄在18-75岁之间者； （5）自愿参加本临床研究并已签署知情同意书者，签署知情同意书过程应符合伦理原则。

Inclusion criteria

Only those who possess all of the following items can be included: (1) Patients diagnosed by Western medicine with chronic atrophic gastritis accompanied by intestinal metaplasia; (2) Traditional Chinese medicine syndrome differentiation belongs to those with spleen and stomach weakness and stomach meridian stasis syndrome; (3) Hp negative individuals or those with Hp infection who have undergone eradication treatment and become negative again after one month; (4) Individuals aged between 18 and 75 years old; (5) Those who voluntarily participate in this clinical study and have signed an informed consent form should comply with ethical principles in the process of signing the informed consent form.

排除标准：

具备以下任一项者，不可参与本试验： （1）既往接受胃部手术或者消化道疾病需要手术的患者； （2）妊娠期或准备妊娠妇女（要求终止妊娠者除外），哺乳期妇女； （3）过敏体质，如对两种以上（含两种）药物或食物过敏史者；已知对本药成分过敏者； （4）3个月内参加过其他药物临床研究的患者； （5）根据研究者的判断，认为不适宜参加临床试验的其他患者，例如具有降低入组可能性或使入组复杂化的其他病变，如工作环境经常变动等易造成失访的情况；

Exclusion criteria：

Individuals who meet any of the following criteria are not eligible to participate in this experiment: (1) Patients who have undergone previous stomach surgery or require surgery for gastrointestinal diseases; (2) Pregnant or preparing pregnant women (excluding those who require termination of pregnancy), lactating women; (3) Allergic constitution, such as a history of allergies to two or more drugs or foods; Individuals who are known to be allergic to the ingredients of this medicine; (4) Patients who have participated in clinical studies of other drugs within 3 months; (5) According to the researcher's judgment, other patients who are deemed unsuitable to participate in clinical trials, such as other lesions that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, are prone to loss of follow-up;

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-01 00:00:00 至 To 2025-03-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

72

Group：

Experimental group

Sample size：

干预措施：

温胃散积膏，口服，每日三次，每次一汤匙（15-18毫升）

干预措施代码：

Intervention：

Wen Wei San Ji Gao, oral, three times a day, one tablespoon each time (15-18 milliliters)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China 

Province：

Shaanxi 

City：

 

单位(医院)：

陕西省中医医院 

单位级别：

三甲 

Institution
hospital：

Shaanxi Provincial Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

胃镜病理组织学治疗前后总积分变化值

指标类型：

主要指标

Outcome：

Changes in total score before and after endoscopic histopathological treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃镜病理组织学单项积分治疗前后变化值

指标类型：

主要指标

Outcome：

Changes in single integral score of gastroscopy histopathology before and after treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病理疗效有效率

指标类型：

次要指标

Outcome：

Pathological efficacy and effectiveness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

单项症状疗效

指标类型：

次要指标

Outcome：

Single symptom efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候疗效

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome Therapeutic Effect

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃肠道肿瘤标志物各项指标实测值治疗前后变化值

指标类型：

次要指标

Outcome：

Changes in measured values of various indicators of gastrointestinal tumor markers before and after treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃泌素-17实测值治疗前后变化值

指标类型：

次要指标

Outcome：

Changes in measured values of gastrin-17 before and after treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃蛋白酶原实测值治疗前后变化值

指标类型：

次要指标

Outcome：

Changes in measured values of pepsinogen before and after treatment

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：

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

大便

组织：

Sample Name：

Stool

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

胃粘膜组织

组织：

Sample Name：

Gastric mucosal tissue

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 岁 years
最大 Max age 75 岁 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）：

本次研究不涉及随机分组和盲法

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

This study does not involve random grouping or blinding

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

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）：

无

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

None

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：

病例报告表(CRF)的填写与移交：⑴全部病例，无论是符合试验方案的病例还是脱落病例，均应按本方案规定，认真填写《病例报告表》。各临床试验参加单位主要研究者应对本中心试验数据的真实性负责。⑵原始化验单必须齐全并保存在受试者文件夹中。《病例报告表》中记录的实验室检查数据或描述，要与原始检验报告核对无误，监查员应对此负责。⑶对实验室检查项目在临床可接受范围以外的数据，无论疗前疗后，研究者均应加以核实，属于非试验疾病或非允许合并的疾病所致者，应及时复查，确属异常者，疗前不能入选，疗后要追访至正常。⑷有关填表说明，见《病例报告表》。⑸完成的病例报告表，由各临床试验单位研究者留存。除非有关药政管理和卫生部门代表要求，未经允许不得将CRF提供给第三者。⑹完成的病例报告表由临床研究者和监查员审查后，交数据统计单位，进行数据录入与管理工作。所有过程均需记录。 数据库的建立和数据的锁定：⑴负责本研究统计工作的单位，负责建立“补脾消积口服液临床试验专用数据库”及全部试验数据的录入工作。采用EpiData数据库进行数据管理，数据录入采取二次录入方式，并对两人独立录入的数据库进行逐项核查、更正，确保录入数据的准确无误。⑵全部病例数据录入完成后，有关数据管理人员进行数据的逻辑核查，对所有核查疑问，数据管理员应填写“数据库核查疑问表”，通过监查员向研究者发出询问，研究者应尽快予以解答，数据管理员据此进行数据的修改、确认，必要时可再次发出疑问表，并按统计分析计划，划分分析人群后对数据库进行锁定。⑶数据库锁定后进行统计分析，撰写《统计分析报告》，由各参试单位主要研究者完成临床试验分中心小结表，临床研究负责单位主要研究者完成多中心总结报告。

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

Filling and Handover of Case Report Form (CRF): ⑴ All cases, whether they are cases that comply with the trial protocol or cases that have fallen out, should carefully fill out the Case Report Form in accordance with the provisions of this protocol. The main researchers of each clinical trial participating unit shall be responsible for the authenticity of the trial data in their own center The original test report must be complete and kept in the subject folder. The laboratory test data or descriptions recorded in the Case Report Form must be verified with the original test report, and the supervisor should be responsible for this For data beyond the clinical acceptable range of laboratory examination items, whether before or after treatment, researchers should verify them. For those caused by non experimental diseases or non allowed concomitant diseases, timely re examination should be conducted. If they are indeed abnormal, they cannot be selected before treatment, and follow-up should be conducted to normal after treatment For instructions on filling out the form, please refer to the "Case Report Form" The completed case report form shall be retained by researchers from various clinical trial units. Unless required by representatives of relevant pharmaceutical management and health departments, CRF shall not be provided to third parties without permission The completed case report form is reviewed by clinical researchers and monitors, and then submitted to the data statistics unit for data entry and management. All processes need to be recorded. Establishment of database and data locking: ⑴ The unit responsible for the statistical work of this study is responsible for establishing the "Clinical Trial Database of Bupi Xiaoji Oral Liquid" and inputting all trial data. Using the EpiData database for data management, data entry adopts a secondary entry method, and the database independently entered by two people is checked and corrected item by item to ensure the accuracy of the entered data After the entry of all case data is completed, the relevant data management personnel conduct logical verification of the data. For all verification questions, the data administrator should fill out the "Database Verification Question Form" and ask the researcher through the supervisor. The researcher should answer as soon as possible, and the data manager should modify and confirm the data based on this. If necessary, the question form can be issued again, and according to the statistical analysis plan, Lock the database after dividing the analysis population After the database is locked, statistical analysis is conducted and a "Statistical Analysis Report" is written. The clinical trial sub center summary table is completed by the main researchers of each participating unit, and the multi center summary report is completed by the main researchers of the clinical research responsible unit.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-03-27 14:40:46