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Based on a retrospective clinical study the clinical efficacy of Shugan Huoxue Tiaozhi Formula in the treatment of metabolic-related fatty liver disease was analyzed

注册号：

Registration number：

ITMCTR2025000709

最近更新日期：

Date of Last Refreshed on：

2025-04-13

注册时间：

Date of Registration：

2025-04-13

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于临床回顾性研究分析疏肝活血调脂方治疗代谢相关脂肪性肝病的临床疗效

Public title：

Based on a retrospective clinical study the clinical efficacy of Shugan Huoxue Tiaozhi Formula in the treatment of metabolic-related fatty liver disease was analyzed

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于临床回顾性研究分析疏肝活血调脂方治疗代谢相关脂肪性肝病的临床疗效

Scientific title：

Based on a retrospective clinical study the clinical efficacy of Shugan Huoxue Tiaozhi Formula in the treatment of metabolic-related fatty liver disease was analyzed

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：

王丽婷

研究负责人：

成扬

Applicant：

WangLiting

Study leader：

Chengyang

申请注册联系人电话：

Applicant telephone：

15156250311

研究负责人电话：

Study leader's telephone：

13817231670

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：

898714310@qq.com

研究负责人电子邮件：

Study leader's E-mail：

drchengyang@126.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：

上海市浦东新区张衡路528号

研究负责人通讯地址：

上海市浦东新区张衡路528号

Applicant address：

No.528 Zhangheng Road Pudong New District Shanghai China

Study leader's address：

No.528 Zhangheng Road Pudong New District Shanghai China

申请注册联系人邮政编码：

Applicant postcode：

201203

研究负责人邮政编码：

Study leader's postcode：

201203

申请人所在单位：

上海中医药大学附属曙光医院

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University 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：

2025-1786-040-02

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：

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/21 0:00:00

伦理委员会联系人：

马俊坚

Contact Name of the ethic committee：

Majunjian

伦理委员会联系地址：

上海市浦东新区张衡路528号

Contact Address of the ethic committee：

No.528 Zhangheng Road Pudong New District Shanghai China

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-20256070

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sgyyllwyh@126.com

研究实施负责（组长）单位：

上海中医药大学附属曙光医院

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市浦东新区张衡路528号

Primary sponsor's address：

No.528 Zhangheng Road Pudong New District Shanghai 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)：

上海市

市(区县)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海中医药大学附属曙光医院

具体地址：

上海市浦东新区张衡路528号

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No.528 Zhangheng Road Pudong New District Shanghai China

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

代谢相关脂肪性肝病

研究疾病代码：

Target disease：

metabolic associated 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：

队列研究

Cohort study

研究所处阶段：

Study phase：

回顾性研究

Retrospective study

研究目的：

主要目的：本研究通过收集整理导师成扬教授治疗代谢相关（非酒精性）脂肪性肝病（MAFLD）患者的临床病案资料，对其进行回顾性分析，探讨疏肝活血调脂方治疗MAFLD的临床疗效。 次要目的：通过收集临床病案资料，总结导师治疗本病的用药规律和治疗方法，为中医药临床治疗此病提供更多参考，并为后续开展高质量临床及基础研究提供客观依据。

Objectives of Study：

The main objective of this study is to collect and organize the clinical case data of patients with metabolic associated (non-alcoholic) fatty liver disease (MAFLD) treated by Professor Cheng Yang conduct a retrospective analysis and explore the clinical efficacy of the Shugan Huoxue Tiaozhi formula in the treatment of MAFLD. The secondary objective is to summarize the medication rules and treatment methods of the mentor for this disease through the collection of clinical case data provide more references for the clinical treatment of this disease with traditional Chinese medicine and offer objective evidence for the subsequent high-quality clinical and basic research.

药物成份或治疗方案详述：

对照组：在基础治疗的基础上，加常规西药水飞蓟素胶囊（利加隆）（140m*10粒/盒），服用方法：每日3次，每次1粒，口服；或多烯磷脂酰胆碱胶囊（易善复）（228mg*24粒/盒），服用方法：每日3次，每次1粒，口服；服药时间不少于12周。 治疗组：在基础治疗的基础上，规律口服以疏肝活血调脂方（药物组成：预知子9g、竹茹9g、水红花子9g、桃仁9g、荷叶15g、制大黄6g、炙甘草6g、绞股蓝18g）为核心处方的中药汤剂，加减如周身困重，夹湿明显者，可加：砂仁3g、杏仁6~9g、薏苡仁15~18g等；湿热偏甚者，可加黄芩6~9g、黄连3g、虎杖9~15g、栀子6~9g等；瘀血征象明显者，可加郁金6~9g、川芎6~9g、延胡索6~9g等；药材均由上海中医药大学附属曙光医院中草药房提供，服药方法：水煎服，每日1剂，每日2次，早晚分服。口服中药时间不少于12周。

Description for medicine or protocol of treatment in detail：

Control group: On the basis of basic treatment patients were given conventional Western medicine either Silymarin Capsules (Lijialong) (140mg*10 capsules per box) with the administration method of 3 times a day 1 capsule each time orally; or Polyene Phosphatidylcholine Capsules (Eshanfu) (228mg*24 capsules per box) with the administration method of 3 times a day 1 capsule each time orally; the medication duration was no less than 12 weeks. Treatment group: On the basis of basic treatment patients were given a traditional Chinese medicine decoction with the core prescription of Shugan Huoxue Tiaozhi Formula (consisting of 9g of Prunus tomentosa 9g of Bambusa arundinacea 9g of Lysimachia sibirica 9g of Prunus persica 15g of Nelumbo nucifera 6g of Prepared Rhubarb 6g of Glycyrrhiza uralensis and 18g of Gynostemma pentaphyllum) orally on a regular basis. If the patient experienced general heaviness and obvious dampness additional ingredients such as 3g of Amomum villosum 6-9g of Prunus armeniaca and 15-18g of Coix seed could be added; if there was a significant damp-heat condition additional ingredients such as 6-9g of Scutellaria baicalensis 3g of Coptis chinensis 9-15g of Polygonum cuspidatum and 6-9g of Gardenia jasminoides could be added; if there were obvious signs of blood stasis additional ingredients such as 6-9g of Curcuma zedoaria 6-9g of Ligusticum chuanxiong and 6-9g of Corydalis yanhusuo could be added. All the herbs were provided by the Chinese Herbal Medicine Pharmacy of Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital. The administration method was decoction 1 dose per day 2 times a day taken in the morning and evening. The duration of oral administration of traditional Chinese medicine was no less than 12 weeks.

纳入标准：

①符合MAFLD诊断标准 ②符合中医肝郁血瘀证辨证标准 ③西医病历资料相对完整，病历资料中记录了临床症状、治疗方法及辅助检查等相关内容； ④中医病历资料中含有详细的四诊信息、治则治法和中药方剂相关记录。 ⑤初诊病历时间至末次复诊病历时间不少于3个月，且复诊病历资料相对完整。

Inclusion criteria

① Meet the diagnostic criteria of MAFLD ② Conform to the TCM syndrome differentiation standard of liver Ganyu Xueyu syndrome ③ The medical records of western medicine were relatively complete and the clinical symptoms treatment methods and auxiliary examinations were recorded in the medical records. ④The TCM medical records contained detailed information of the four diagnoses treatment principles and methods and relevant records of TCM prescriptions. ⑤ The time from the first visit to the last follow-up medical records was not less than 3 months and the follow-up medical records were relatively complete.

排除标准：

①病史资料、临床资料欠缺严重，且无法通过多种途径随访或追溯者； ②治疗周期中未规律服用疏肝活血调脂方加味中药汤剂者； ③伴有慢性病毒性肝炎病史、药物性肝病或者其他严重肝肾功能不全等严重疾病者； ④治疗周期中服用其他中药者； ⑤妊娠或哺乳期妇女； ⑥有严重的心、肝、肾、脑等疾病者。

Exclusion criteria：

① Patients with serious lack of medical history and clinical data and unable to follow up or trace through various ways; ② those who did not regularly take the Shugan Huoxue Tiaozhi decoction during the treatment period; ③ patients with a history of chronic viral hepatitis drug-induced liver disease or other serious liver and kidney dysfunction; ④ taking other traditional Chinese medicine during the treatment cycle; ⑤ pregnant or lactating women; ⑥ patients with serious heart liver kidney brain and other diseases.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2026-05-31

征募观察对象时间：

Recruiting time：

从From 2025-03-31

至To      2026-05-31

干预措施：

Interventions：

组别：

观察组

样本量：

50

Group：

2

Sample size：

干预措施：

在基础治疗的基础上，规律口服以疏肝活血调脂方（药物组成：预知子9g、竹茹9g、水红花子9g、桃仁9g、荷叶15g、制大黄6g、炙甘草6g、绞股蓝18g）为核心处方的中药汤剂，加减如周身困重，夹湿明显者，可加：砂仁3g、杏仁6~9g、薏苡仁15~18g等；湿热偏甚者，可加黄芩6~9g、黄连3g、虎杖9~15g、栀子6~9g等；瘀血征象明显者，可加郁金6~9g、川芎6~9g、延胡索6~9g等；药材均由上海中医药大学附属曙光医院中草药房提供，服药方法：水煎服，每日1剂，每日2次，早晚分服。口服中药时间不少于12周。

干预措施代码：

Intervention：

Based on primary therapy, regularly take Shugan Huoxue Tiaozhi Decoction (YuZhizi 9g, Zhuru 9g, ShuiHonghuazi 9g, Taoren 9g, Heye 15g, ZhiDahuang 6g, ZhiGancao 6g, Jiaogulan 18g). Modifications: add Sharen 3g/Xingren 6-9g/Yiyiren 15-18g for dampness; Huangqin 6-9g/Huanglian 3g/Huzhang 9-15g for damp-heat; Yujin 6-9g/Chuanxiong 6-9g/Yanhusuo 6-9g for blood stasis. Herbs provided by Shuguang Hospital. Decoction: 1 dose daily (twice) for ≥12 weeks.

Intervention code：

组别：

对照组

样本量：

50

Group：

1

Sample size：

干预措施：

在基础治疗的基础上，加常规西药水飞蓟素胶囊（利加隆）（140m*10粒/盒），服用方法：每日3次，每次1粒，口服；或多烯磷脂酰胆碱胶囊（易善复）（228mg*24粒/盒），服用方法：每日3次，每次1粒，口服；服药时间不少于12周。

干预措施代码：

Intervention：

On the basis of basic treatment patients were given conventional Western medicine either Silymarin Capsules (Lijialong) (140mg*10 capsules per box) with the administration method of 3 times a day 1 capsule each time orally; or Polyene Phosphatidylcholine Capsules (Eshanfu) (228mg*24 capsules per box) with the administration method of 3 times a day 1 capsule each time orally; the medication duration was no less than 12 weeks.

Intervention code：

样本总量 Total sample size ： 100

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)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海中医药大学附属曙光医院

单位级别：

上海市浦东新区张衡路528号

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

No.528 Zhangheng Road Pudong New District Shanghai China

测量指标：

Outcomes：

指标中文名：

肝功能

指标类型：

主要指标

Outcome：

liver function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝纤维化-4指数评分

指标类型：

次要指标

Outcome：

Hepatic fibrosis-4 index 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：

肾功能

指标类型：

副作用指标

Outcome：

renal function

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝脏超声

指标类型：

主要指标

Outcome：

Liver ultrasound

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝脏弹性超声

指标类型：

主要指标

Outcome：

FibroScan

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血脂

指标类型：

次要指标

Outcome：

blood fat

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医症候积分

指标类型：

主要指标

Outcome：

TCM syndrome score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血常规

指标类型：

副作用指标

Outcome：

blood routine examination

Type：

Adverse events

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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 10 岁
Min age years
最大 100 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）：

本研究为观察性病例对照研究。不进行随机对照试验。

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

/

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）：

无

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：

病例记录表

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

CRF

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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