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Study on the real world and biological evidence of Xiaozheng Sanjie method in the treatment of chronic kidney disease based on traditional Chinese medicine flaccidity theory

注册号：

Registration number：

ITMCTR2100005474

最近更新日期：

Date of Last Refreshed on：

2021-12-30

注册时间：

Date of Registration：

2021-12-30

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于中医痿理论消癥散结法治疗慢性肾脏疾病的真实世界及生物学证据研究

Public title：

Study on the real world and biological evidence of Xiaozheng Sanjie method in the treatment of chronic kidney disease based on traditional Chinese medicine flaccidity theory

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于中医痿理论消癥散结法治疗慢性肾脏疾病的真实世界及生物学证据研究

Scientific title：

Study on the real world and biological evidence of Xiaozheng Sanjie method in the treatment of chronic kidney disease based on traditional Chinese medicine flaccidity theory

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：

ChiCTR2100055024 ; ChiMCTR2100005474

申请注册联系人：

董涵之

研究负责人：

樊均明

Applicant：

Hanzhidong

Study leader：

Junmingfan

申请注册联系人电话：

Applicant telephone：

17760470598

研究负责人电话：

Study leader's telephone：

13908199530

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：

404146030@qq.com

研究负责人电子邮件：

Study leader's E-mail：

junmingfan@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：

四川省成都市新都区状元街20号

研究负责人通讯地址：

四川省成都市新都区宝光大道中段278号

Applicant address：

No. 20 Zhuangyuan street, Xindu District, Chengdu, Sichuan

Study leader's address：

No. 278, middle section of Baoguang Avenue, Xindu District, Chengdu, Sichuan

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：

成都医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Chengdu Medical College

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：

2021CYFYIRB-RA-70-01

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：

成都医学院第一附属医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of the First Affiliated Hospital of Chengdu Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2021/12/7 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

成都医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Chengdu Medical College

研究实施负责（组长）单位地址：

四川省成都市新都区宝光大道中段278号

Primary sponsor's address：

No. 278, middle section of Baoguang Avenue, Xindu District, Chengdu, Sichuan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都医学院第一附属医院

具体地址：

四川省成都市新都区宝光大道中段278号

Institution
hospital：

The First Affiliated Hospital of Chengdu Medical College

Address：

No. 278, middle section of Baoguang Avenue, Xindu District, Chengdu, Sichuan

经费或物资来源：

四川省科技厅项目

Source(s) of funding：

Project of Sichuan Provincial Department of science and technology

研究疾病：

慢性肾脏病

研究疾病代码：

Target disease：

Chronic kidney disease

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

慢性肾脏疾病（Chronic Kidney Diseases，CKD）是严重危害人类健康的常见疾病。中国20岁以上成年人慢性肾脏病的患病率在10%左右[1]。目前，延缓慢性肾脏疾病进展缺乏有效治疗方法，预后差，常进展至终末期肾脏疾病，慢性肾脏病已成为世界范围内的重要公共健 康问题。中医药治疗肾脏病有悠久的历史，研究表明，六味地黄汤、柴苓汤、益气活血化湿等方均能有效治疗肾脏病[2-3]；已证实中药大黄、黄芪、雷公藤、冬虫夏草等在治疗慢性肾脏疾病进展过程中有肯定的疗效[4-5]。 四川生态环境和气候多样，药材资源丰富，素有“中医之乡，中药之库”之美誉，在全国重点普查的430种重要中药材资源中，四川省出产的达到383种[6]。据研究，川产川芎、丹参、牛膝、黄柏、大黄和黄芪等对慢性肾脏病有明确的临床作用[7-11]。因此，结合地域特点，加强慢性肾脏病防治，延缓疾病进展，创新道地川药治疗慢性肾脏病具有重要社会学和卫生经济学意义。 中医药防治疾病的精髓是基于理法方药指导下的辩证施治，不同疾病具有同样病机，可异病同治。现代医学认为，肾纤维化被认为是损伤或应激引起的伴随细胞外基质过量堆积的异常修复模式。炎症是纤维化的启动因素，参与肾纤维化的发生发展，而Toll样受体4(TLR4)及其信号通路激活可促进炎症因子、趋化因子分泌、巨噬细胞极化及氧化应激，最终诱导细胞转分化、细胞外基质分泌增加促进纤维化形成。本团队假设川产道地中药可干预肾脏纤维化。项目拟阐明中医药防止肾纤维化的细胞分子机制和信号作用靶点，为中医药治疗慢性肾脏病提供重要的科学理论。

Objectives of Study：

Chronic kidney diseases (CKD) is a common disease seriously endangering human health. The prevalence of chronic kidney diseases in Chinese adults over 20 years old is about 10% [1] At present, there is no effective treatment to delay the progress of chronic kidney disease, and the prognosis is poor. It often progresses to end-stage renal disease. Chronic kidney disease has become an important public health problem all over the world. Traditional Chinese medicine has a long history in the treatment of kidney diseases. Research shows that Liuwei Dihuang Decoction, Chailing decoction, supplementing qi, activating blood circulation and removing dampness can effectively treat kidney diseases [2-3]; It has been confirmed that rhubarb, Astragalus membranaceus, Tripterygium Wilfordii and Cordyceps sinensis have certain curative effects in the treatment of the progression of chronic kidney disease [4-5]. Sichuan has diverse ecological environment and climate and rich medicinal materials resources. It is known as "the hometown of traditional Chinese medicine and the repository of traditional Chinese medicine". Among the 430 important medicinal materials resources in the national key census, 383 kinds are produced in Sichuan Province [6]. According to research, Ligusticum chuanxiong, Salvia miltiorrhiza, Achyranthes bidentata, Cortex Phellodendri, rhubarb and Astragalus membranaceus produced in Sichuan have clear clinical effects on chronic kidney disease [7-11]. Therefore, combined with regional characteristics, strengthening the prevention and treatment of chronic kidney disease, delaying disease progress and innovating authentic Sichuan medicine in the treatment of chronic kidney disease has important sociological and health economics significance. The essence of disease prevention and treatment of traditional Chinese medicine is based on dialectical treatment under the guidance of principles, methods, prescriptions and drugs. Different diseases have the same pathogenesis and can be treated together. Modern medicine believes that renal fibrosis is considered as an abnormal repair mode caused by injury or stress with excessive accumulation of extracellular matrix. Inflammation is the initiating factor of fibrosis and participates in the occurrence and development of renal fibrosis. The activation of Toll like receptor 4 (TLR4) and its signal pathway can promote the secretion of inflammatory factors, chemokines, macrophage polarization and oxidative stress, and finally induce cell transdifferentiation, increase the secretion of extracellular matrix and promote the formation of fibrosis. The team hypothesized that Sichuan genuine traditional Chinese medicine can intervene in renal fibrosis. The project intends to clarify the cellular and molecular mechanism and signal target of traditional Chinese medicine to prevent renal fibrosis, so as to provide important scientific theory for the treatment of chronic kidney disease with traditional Chinese medicine.

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 2012 年 KDIGO 慢性肾脏疾病（CKD）临床实践指南规定的诊断标准的 3-4 期 患者(KidneyInternationalSupplements.2013,3:1-150.） ②年龄 18-75 岁。 ③参加筛选前患者本人或其监护人已签署知情同意书。

Inclusion criteria

① Stage 3-4 patients who meet the diagnostic criteria specified in the 2012 KDIGO clinical practice guidelines for chronic kidney disease (CKD) (kidney international supplies. 2013,3:1-150.) ② Age 18-75 years old. ③ The patient or his guardian has signed the informed consent before participating in the screening.

排除标准：

①各种原因引起的急性肾损伤。 ②合并肝脏和造血系统等严重原发性疾病、严重感染、精神异常、恶性肿瘤患者。 ③血液透析、腹膜透析、肾脏移植等肾替代治疗患者。 ④年龄在 18 岁以下或 75 岁以上，妊娠或哺乳期妇女。 ⑤正在接受其他临床实验研究。

Exclusion criteria：

① Acute renal injury caused by various causes. ② Patients with severe primary diseases such as liver and hematopoietic system, serious infection, mental abnormalities and malignant tumors. ③ Patients with renal replacement therapy such as hemodialysis, peritoneal dialysis and kidney transplantation. ④ Pregnant or lactating women under the age of 18 or over 75. ⑤ Other clinical trials are under way.

研究实施时间：

Study execute time：

从From 2022-01-01

至To      2023-03-28

征募观察对象时间：

Recruiting time：

从From 2022-01-01

至To      2022-04-01

干预措施：

Interventions：

组别：

消癥散结中药复方治疗组

样本量：

500

Group：

control group

Sample size：

干预措施：

中药复方

干预措施代码：

Intervention：

Traditional Chinese medicine compound

Intervention code：

组别：

对照组

样本量：

500

Group：

Control group

Sample size：

干预措施：

常规治疗

干预措施代码：

Intervention：

Conventional treatment

Intervention code：

样本总量 Total sample size ： 1000

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都医学院第一附属医院

单位级别：

三甲医院

Institution/hospital：

The First Affiliated Hospital of Chengdu Medical College

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

肾功指标

指标类型：

主要指标

Outcome：

Renal function index

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 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）：

按照患者实际病情和个人意愿等实际情况进行分组。

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

The patients were grouped according to their actual condition and personal wishes.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

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）：

2023.04

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

2023.04

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：

Case record form

数据管理委员会：

Data Managemen Committee：

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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