强肝胶囊治疗非酒精性脂肪性肝病真实世界注册登记研究

注册号:

Registration number:

ITMCTR2200005766

最近更新日期:

Date of Last Refreshed on:

2022-03-26

注册时间:

Date of Registration:

2022-03-26

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

强肝胶囊治疗非酒精性脂肪性肝病真实世界注册登记研究

Public title:

Real world registration of Qianggan Capsule in the treatment of nonalcoholic fatty liver disease

注册题目简写:

English Acronym:

研究课题的正式科学名称:

强肝胶囊治疗非酒精性脂肪性肝病真实世界注册登记研究

Scientific title:

Real world registration of Qianggan Capsule in the treatment of nonalcoholic fatty liver disease

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:

ChiCTR2200058019 ; ChiMCTR2200005766

申请注册联系人:

胡良军

研究负责人:

季光

Applicant:

liangjun Hu

Study leader:

guang Ji

申请注册联系人电话:

Applicant telephone:

15827639709

研究负责人电话:

Study leader's telephone:

13816018198

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:

16765084@qq.com

研究负责人电子邮件:

Study leader's E-mail:

jg@shutcm.edu.cn

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:

湖北省武汉市江汉区建设大道586号新世界国贸大厦4318

研究负责人通讯地址:

上海市徐汇区宛平南路725号

Applicant address:

4318, new world international trade building, 586 Jianshe Avenue, Jianghan District, Wuhan City, Hubei Province

Study leader's address:

725 Wanping South Road, Xuhui District, Shanghai;

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:

施维特(武汉)医学科技有限公司

Applicant's institution:

Schwitt (Wuhan) Medical Technology Co., Ltd

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:

ChiECRCT20220031

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:

中国注册临床试验伦理委员会

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials

伦理委员会批准日期:

Date of approved by ethic committee:

2022/2/20 0:00:00

伦理委员会联系人:

吴泰相

Contact Name of the ethic committee:

Taixiang WU

伦理委员会联系地址:

四川省成都市国学巷37号行政楼八角亭2092

Contact Address of the ethic committee:

2092 Bajiaoting, administration building, No. 37, Guoxue lane, Chengdu, Sichuan

伦理委员会联系人电话:

Contact phone of the ethic committee:

18980604562

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:

上海中医药大学附属龙华医院

Primary sponsor:

Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市徐汇区宛平南路725号

Primary sponsor's address:

725 Wanping South Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北省

市(区县):

石家庄

Country:

china

Province:

Hebei

City:

Shijiazhuang

单位(医院):

石家庄东方药业股份有限公司

具体地址:

河北省石家庄市高新区仓盛路528号

Institution
hospital:

Shijiazhuang Dongfang Pharmaceutical Co., Ltd

Address:

No. 528, cangsheng Road, high tech Zone, Shijiazhuang, Hebei

经费或物资来源:

自筹

Source(s) of funding:

raise independently

研究疾病:

非酒精性脂肪性肝病

研究疾病代码:

Target disease:

Nonalcoholic fatty liver disease

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

连续入组

Sequential

研究所处阶段:

Study phase:

上市后药物

Post-marketing clinical trial

研究目的:

在真实世界医疗环境下,评估强肝胶囊治疗NAFLD患者的临床转归及安全性; 观察强肝胶囊治疗NAFLD患者肝功谷丙转氨酶(ATL)及代谢指标甘油三酯(TG)的变化; 观察强肝胶囊治疗NAFLD患者的中医证候变化。

Objectives of Study:

To evaluate the clinical outcome and safety of Qianggan Capsule in the treatment of NAFLD patients in a real-world medical environment; To observe the changes of liver function alanine aminotransferase (ATL) and metabolic index triglyceride (TG) in patients with NAFLD treated with Qianggan capsule; To observe the changes of TCM syndromes in patients with NAFLD treated with Qianggan capsule.

药物成份或治疗方案详述:

本项研究为一项多中心、前瞻性、观察性的真实世界注册登记研究研究,采取连续入组方式,计划在全国等级医院(二、三级医院)、社区/乡镇卫生院等300家以上公立医疗机构招募10000例NAFLD患者,治疗观察周期180天,共计设置4次访视

Description for medicine or protocol of treatment in detail:

This study is a multi center, prospective and observational real-world registration study. It is planned to recruit 10000 patients with NAFLD in more than 300 public medical institutions such as national level hospitals (Level II and III hospitals) and community / township health centers. The treatment observation cycle is 180 days, with a total of 4 visits

纳入标准:

符合西医NAFLD诊断标准; 年龄18--80岁; 性别不限; 受试者同意加入本次临床研究,自愿签订了知情同意书,并同意按照研究方案的要求参加访视、检查、治疗。

Inclusion criteria

Meet the diagnostic criteria of NAFLD in western medicine; Age 18-80 years old; Unlimited gender; The subjects agreed to join the clinical study, voluntarily signed the informed consent form, and agreed to participate in the visit, examination and treatment according to the requirements of the research plan.

排除标准:

妊娠和哺乳期女性; 研究者认为不适合参与本研究的患者;

Exclusion criteria:

Pregnant and lactating women; Patients considered unsuitable by the investigator to participate in this study;

研究实施时间:

Study execute time:

From 2022-04-01

To      2025-05-31

征募观察对象时间:

Recruiting time:

From 2022-04-01

To      2025-05-31

干预措施:

Interventions:

组别:

观察组

样本量:

10000

Group:

Observation group

Sample size:

干预措施:

常规治疗+强肝胶囊

干预措施代码:

Intervention:

Routine treatment + Qianggan capsule

Intervention code:

样本总量 Total sample size : 10000

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

单位级别:

三级甲等

Institution/hospital:

Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Level of the institution:

Class III class A

测量指标:

Outcomes:

指标中文名:

治疗前后中医证候评分变化

指标类型:

主要指标

Outcome:

Changes of TCM syndrome score 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:

ALT水平恢复至正常(≤40U/L)或ALT水平下降≥30%的患者比例

指标类型:

主要指标

Outcome:

Proportion of patients whose ALT level returned to normal (≤ 40u / L) or whose ALT level decreased by ≥ 30%

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗前后肝部影像学(CT、核磁共振、瞬时弹性、B超等)前后变化

指标类型:

次要指标

Outcome:

Changes of liver imaging (CT, MRI, transient elasticity, B-ultrasound, etc.) 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:

治疗前后甘油三酯(TG)比值的变化、治疗后恢复至正常(≤1.88mmol/L)的患者比例。

指标类型:

主要指标

Outcome:

The change of triglyceride (TG) ratio before and after treatment and the proportion of patients who returned to normal (≤ 1.88 mmol / L) after treatment.

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:

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

连续入组,不采用随机对照试验

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

The patients were enrolled continuously without randomized controlled trial

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

非酒精性脂肪肝病临床科研与疾病管理大数据平台http://nafld.shivictory.com/home/main

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

Big data platform for clinical research and disease management of nonalcoholic fatty liver disease http://nafld.shivictory.com/home/main

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:

非酒精性脂肪肝病临床科研与疾病管理大数据平台http://nafld.shivictory.com/home/main

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

Big data platform for clinical research and disease management of nonalcoholic fatty liver disease http://nafld.shivictory.com/home/main

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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