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Study on the effective prescriptions for the treatment of liver injury and their anti-inflammatory and hepatoprotective mechanisms by famous old Chinese medicine practitioners

注册号：

Registration number：

ITMCTR2022000097

最近更新日期：

Date of Last Refreshed on：

2022-09-26

注册时间：

Date of Registration：

2022-06-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

名老中医辨治肝损伤有效方药挖掘及其抗炎保肝机制研究

Public title：

Study on the effective prescriptions for the treatment of liver injury and their anti-inflammatory and hepatoprotective mechanisms by famous old Chinese medicine practitioners

注册题目简写：

名老中医经验挖掘及机制研究

English Acronym：

Research on the Experience of Famous Old Chinese Medicine Practitioners and Mechanisms

研究课题的正式科学名称：

名老中医辨治肝损伤有效方药挖掘及其抗炎保肝机制研究

Scientific title：

Study on the effective prescriptions for the treatment of liver injury and their anti-inflammatory and hepatoprotective mechanisms by famous old Chinese medicine practitioners

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：

CIA2021A00806

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：

ChiCTR2200064034 ; ChiMCTR2200006647

申请注册联系人：

陈秋叶

研究负责人：

白宇宁

Applicant：

Qiuye Chen

Study leader：

Yuning Bai

申请注册联系人电话：

Applicant telephone：

17812171517

研究负责人电话：

Study leader's telephone：

13366266838

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：

1304879405@qq.com

研究负责人电子邮件：

Study leader's E-mail：

byn-1973@163.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：

北京市西城区北线阁5号

研究负责人通讯地址：

北京市西城区北线阁5号

Applicant address：

No.5 Beiliange, Xicheng District, Beijing

Study leader's address：

No.5 Beiliange, Xicheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100032

研究负责人邮政编码：

Study leader's postcode：

100032

申请人所在单位：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

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：

2022-198-KY-01

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2022/9/1 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Qiao Jie

伦理委员会联系地址：

北京市西城区北线阁5号中国中医科学院广安门医院4号楼4层452

Contact Address of the ethic committee：

Room 452, 4th Floor, Building 4, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian Pavilion, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-88001552

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：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市西城区北线阁5号

Primary sponsor's address：

No.5 Beiliange, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁5号

Institution
hospital：

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

Address：

No.5 Beiliange, Xicheng District, Beijing

经费或物资来源：

中国中医科学院科技创新工程项目

Source(s) of funding：

Science and Technology Innovation Project of the Chinese Academy of Traditional Chinese Medicine

研究疾病：

慢性肝损伤

研究疾病代码：

Target disease：

Chronic liver injury

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

横断面

Cross-sectional

研究所处阶段：

Study phase：

其它

Others

研究目的：

本项目基于“有效临床经验→核心方药→基础机制”模式，首先构建名老中医治疗肝损伤临床病例数据库，通过数据挖掘总结形成名老中医治疗肝损伤辨治规律及有效核心方药。其次基于“核心方药成分-作用分子蛋白靶点-肝损伤”关联进行网络药理学研究，分析核心方药抗炎保肝可能的干预靶点和途径。同时进行核心方药干预C57BL/6小鼠对乙酰氨基酚肝损伤模型蛋白组学研究，进一步明确其抗炎保肝作用的蛋白靶点。

Objectives of Study：

Based on the model of effective clinical experience→core prescriptions→basic mechanism, this project firstly constructs a database of clinical cases of famous and old Chinese medicine for treating liver injury, and forms the law of differentiation and treatment of famous old Chinese medicine for liver injury and effective core prescriptions through data mining and summarization. Secondly, a network pharmacology study was carried out based on the correlation of "core prescription ingredients-acting molecular protein targets-liver injury", and the possible intervention targets and pathways of core prescriptions for anti-inflammatory and liver protection were analyzed. At the same time, a proteomic study of the core prescription intervention in C57BL/6 mice model of acetaminophen liver injury was conducted to further clarify the protein targets of its anti-inflammatory and hepatoprotective effects.

药物成份或治疗方案详述：

暂无

Description for medicine or protocol of treatment in detail：

No

纳入标准：

①经名老中医辨治的肝功能异常相关疾病，主要包括：病毒性肝炎、酒精性肝病、非酒精性脂肪性肝炎、自身免疫性肝炎、肝硬化、药物性肝损伤等； ②病历信息完整，包括：患者一般信息、症状体征、四诊信息、中西医诊断、证候、治则治法、方剂名称及组成、辅助检查等； ③使用中药治疗为主，包括纯中药治疗，或治疗周期中80%以上的时间单独使用中药治疗； ④有复诊信息，至少就诊2次，并对治疗前后均对肝功能进行了评估，有明确证明疗效的文字记录或辅助检查。 ④有复诊信息，至少就诊2次，并对治疗前后均对肝功能进行了评估，有明确证明疗效的文字记录或辅助检查。

Inclusion criteria

① Diseases related to abnormal liver function that have been differentiated and treated by famous Chinese medicine practitioners, mainly including: viral hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, liver cirrhosis, drug-induced liver injury, etc.; ② Complete medical record information, including: general information of patients, symptoms and signs, information on four diagnoses, diagnosis of traditional Chinese and Western medicine, syndromes, principles and methods of treatment, name and composition of prescriptions, auxiliary examinations, etc.; ③ Mainly using traditional Chinese medicine treatment, including pure traditional Chinese medicine treatment, or using traditional Chinese medicine alone for more than 80% of the time in the treatment cycle; ④ There is information on follow-up visits, at least 2 visits, and liver function assessment before and after treatment, with written records or auxiliary examinations that clearly prove the curative effect.

排除标准：

①患者病历信息数据资料不全，影响评估及数据分析者； ②合并有重要脏器（如心、脑、肺、肝、肾）急慢性严重疾病。

Exclusion criteria：

① The patient's medical record information and data are incomplete, which affects the assessment and data analysis; ② Combined with acute and chronic serious diseases of important organs (such as heart, brain, lung, liver, kidney).

研究实施时间：

Study execute time：

从From 2021-12-01

至To      2024-12-31

征募观察对象时间：

Recruiting time：

从From 2022-09-17

至To      2023-06-30

干预措施：

Interventions：

组别：

观察组

样本量：

300

Group：

observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

no

Intervention code：

样本总量 Total sample size ： 300

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)：

西城区

Country：

China

Province：

Beijing

City：

Xicheng District

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Level of the institution：

tertiary first class

测量指标：

Outcomes：

指标中文名：

方药

指标类型：

主要指标

Outcome：

prescription

Type：

Primary 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：

无

组织：

Sample Name：

no

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
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）：

无

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

no

盲法：

Blinding：

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）：

暂未公开原始数据

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

Raw data not yet publicly available

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：

数据采集：①“十五”国家科技攻关计划、“十一五”、“十二五”国家科技支撑计划项目“名老中医学术思想、临床经验传承研究”收集的名老中医医案、北京市科技计划重大项目名医传承课题收集的医案、中国中医科学院“名医名家”传承项目纳入的医案； ②以上名老中医出版的专著中的医案；③以上名老中医发表于学术期刊中的医案；④以上名老中医在广安门医院出诊录入的符合纳入标准的完整医案。 数据管理：广安门医院名医名家经验传承知识管理与服务平台

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

Data collection: ①The medical cases collected by the National Science and Technology Tackling Program of the Tenth Five-Year Plan, the Eleventh Five-Year Plan and the Twelfth Five-Year Plan (2) The medical cases in the monographs published by the above-mentioned famous and veteran Chinese medicine practitioners; (3) The medical cases published in academic journals by the above-mentioned famous and veteran Chinese medicine practitioners; (4) The complete medical cases entered by the above-mentioned famous and veteran Chinese medicine practitioners in their consultations at Guanganmen Hospital that meet the inclusion criteria. Data management: Knowledge management and service platform for the inheritance of experience of famous doctors and experts at Guang'anmen Hospital

数据管理委员会：

Data Managemen Committee：

有

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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