甬派中医慢性肾衰病辨治理论的传承和创新研究

注册号:

Registration number:

ITMCTR2025001372

最近更新日期:

Date of Last Refreshed on:

2025-07-09

注册时间:

Date of Registration:

2025-07-09

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

甬派中医慢性肾衰病辨治理论的传承和创新研究

Public title:

Research on the Inheritance and Innovation of Yongpai Traditional Chinese Medicine Theory in the Diagnosis and Treatment of Chronic Renal Failure

注册题目简写:

English Acronym:

研究课题的正式科学名称:

甬派中医慢性肾衰病辨治理论的传承和创新研究

Scientific title:

Research on the Inheritance and Innovation of Yongpai Traditional Chinese Medicine Theory in the Diagnosis and Treatment of Chronic Renal Failure

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:

林晓蒙

研究负责人:

蔡旭东

Applicant:

Lin Xiaomeng

Study leader:

Cai Xudong

申请注册联系人电话:

Applicant telephone:

13567924194

研究负责人电话:

Study leader's telephone:

13777124877

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:

linxiaomeng521@163.com

研究负责人电子邮件:

Study leader's E-mail:

13777124877@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:

浙江省宁波市海曙区丽园北路819号

研究负责人通讯地址:

浙江省宁波市海曙区丽园北路819号

Applicant address:

No. 819 Liyuan North Road Haishu District Ningbo City Zhejiang Province China

Study leader's address:

No. 819 Liyuan North Road Haishu District Ningbo City Zhejiang Province China

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:

浙江省中医药大学附属宁波市中医院

Applicant's institution:

Ningbo Municipal Hospital of Traditional Chinese Medicine(TCM) Affiliated Hospital of Zhejiang Chinese Medical University

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:

宁波市中医院伦审2022研第001号-01;宁波市中医院伦审2022研第001号-04(修正后)

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:

宁波市中医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Ningbo Hospital of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/9/5 0:00:00

伦理委员会联系人:

朱瑛

Contact Name of the ethic committee:

Zhu Ying

伦理委员会联系地址:

浙江省宁波市海曙区丽园北路819号

Contact Address of the ethic committee:

No. 819 Liyuan North Road Haishu District Ningbo City Zhejiang Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

0574-87089090

伦理委员会联系人邮箱:

Contact email of the ethic committee:

nbszyy_MEC@163.com

研究实施负责(组长)单位:

浙江省中医药大学附属宁波市中医院

Primary sponsor:

Ningbo Municipal Hospital of Traditional Chinese Medicine(TCM) Affiliated Hospital of Zhejiang Chinese Medical University

研究实施负责(组长)单位地址:

浙江省宁波市海曙区丽园北路819号

Primary sponsor's address:

No. 819 Liyuan North Road Haishu District Ningbo City Zhejiang Province 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):

浙江省

市(区县):

Country:

CHINA

Province:

Zhejiang Province

City:

单位(医院):

浙江省中医药大学附属宁波市中医院

具体地址:

浙江省宁波市海曙区丽园北路819号

Institution
hospital:

Ningbo Municipal Hospital of Traditional Chinese Medicine(TCM) Affiliated Hospital of Zhejiang Chinese Medical University

Address:

No. 819 Liyuan North Road Haishu District Ningbo City Zhejiang Province China

经费或物资来源:

宁波市科学技术局

Source(s) of funding:

Ningbo science and technology bureau

研究疾病:

慢性肾衰病

研究疾病代码:

Target disease:

Chronic Renal Failure

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本项目拟传承甬派中医代表人物张沛虬先生在治疗慢性肾衰病上的经典辨证理论及内治的中药名方,于临床阳虚血瘀、气虚血瘀、阴虚血瘀为辨证特点的三类慢性肾衰病人群开展应用,观察肾纤维化、肾功能进展预测及肠道尿毒素相关血清指标,应用风险预测模型评估预后变化,科学验证中医药综合治疗方案的有效性,从而建立慢性肾衰病的中医综合诊疗方案。 (1)科学验证益气消癥方、温阳消癥方和补虚消癥方治疗对应证型慢性肾衰病的有效性和安全性; (2)运用代谢组学探究其治疗作用机制。

Objectives of Study:

This project aims to inherit and develop the classical diagnostic theory and internal herbal formulas of Professor Zhang Peiqiong a leading figure of Yongpai Traditional Chinese Medicine (TCM) for treating chronic renal failure (CRF). The study will focus on three CRF patient subtypes characterized by distinct TCM patterns: (1) Yang deficiency with blood stasis (2) Qi deficiency with blood stasis and (3) Yin deficiency with blood stasis.We will clinically evaluate the therapeutic effects by monitoring renal fibrosis progression renal function predictive markers and serum levels of gut-derived uremic toxins. A risk prediction model will be applied to assess prognostic changes. Through scientific validation of this comprehensive TCM therapeutic approach we intend to establish an integrated TCM diagnostic and treatment protocol for CRF 1) To scientifically validate the efficacy and safety of Yiqi Xiaozheng Formula (Qi-invigorating anti-fibrosis formula) Wenyang Xiaozheng Formula (Yang-warming anti-fibrosis formula) and Buxu Xiaozheng Formula (deficiency-tonifying anti-fibrosis formula) in treating corresponding syndrome types of chronic renal failure (CRF). 2) To investigate their therapeutic mechanisms using metabolomics approaches.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

慢性肾脏病患者纳入标准①符合慢性肾脏病(CKD3-5期)的西医诊断标准;②中医辨证属气虚血瘀,或阳虚血瘀,或阴虚血瘀证型; ③年龄在18-75岁之间; ④有效控制感染、酸中毒、电解质紊乱和高血压等并发症、合并症 ⑤受试者同意,并签署进入临床研究的知情同意书。 健康者纳入标准①符合不以治疗获益为目的参加实验,健康状况良好,无与此次研究相关疾病的受试者;②患者年龄在 18-75岁之间; ③有较为完善的体检资料者,受试者同意,并签署进入临床研究的知情同意书。

Inclusion criteria

Inclusion Criteria for Chronic Kidney Disease (CKD) Patients:①Meeting the Western diagnostic criteria for chronic kidney disease (CKD stages 3-5);②TCM syndrome differentiation consistent with:Qi deficiency with blood stasis or Yang deficiency with blood stasis or Yin deficiency with blood stasis;③Age between 18–75 years;④Controlled comorbidities including infections acidosis electrolyte imbalances and hypertension;⑤Willingness to participate with signed informed consent for clinical research. Inclusion Criteria for Healthy Controls①Healthy volunteers (non-therapeutic participation) without diseases relevant to the study;②Healthy volunteers (non-therapeutic participation) without diseases relevant to the study;③Availability of complete medical records and signed informed consent.

排除标准:

①妊娠或哺乳期妇女;②合并有心、脑、肝和造血系统等严重原发性疾病,严重感染,恶性肿瘤,对试验用药物过敏等; ③无法合作者,如精神病患者;④拒绝接受治疗,或不签署知情同意书者。 以上任意一种情况出现均为排除病例

Exclusion criteria:

①Pregnancy or lactation;②Severe comorbidities including:major primary diseases of the heart brain liver or hematopoietic systemsevere infectionsmalignancy (cancer)allergy/hypersensitivity to the investigational drugs;③Non-cooperative patients such as those with psychiatric disorders affecting compliance;④Refusal to participate including:unwillingness to undergo treatmentdeclining to sign the informed consent form. Any of the above conditions will lead to exclusion from the study.

研究实施时间:

Study execute time:

From 2023-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-09-06

To      2025-06-30

干预措施:

Interventions:

组别:

气虚血瘀型中药复方组

样本量:

30

Group:

Traditional Chinese Medicine (TCM) Compound Formula Group for Qi Deficiency with Blood Stasis Pattern

Sample size:

干预措施:

益气消癥方+基础治疗

干预措施代码:

Intervention:

Yiqi Xiaozheng Formula+Standard Treatment

Intervention code:

组别:

阳虚血瘀型中药复方组

样本量:

30

Group:

Traditional Chinese Medicine (TCM) Compound Formula Group for Yang Deficiency with Blood Stasis Pattern

Sample size:

干预措施:

温阳消癥方+基础治疗

干预措施代码:

Intervention:

Wenyang Xiaozheng Formula+Standard Treatment

Intervention code:

组别:

阴虚血瘀型中药复方组

样本量:

30

Group:

Traditional Chinese Medicine (TCM) Compound Formula Group for Yin Deficiency with Blood Stasis Pattern

Sample size:

干预措施:

补虚消癥方+基础治疗

干预措施代码:

Intervention:

Buxu Xiaozheng Formula+Standard Treatment

Intervention code:

组别:

健康人组

样本量:

30

Group:

Healthy Control Group

Sample size:

干预措施:

无干预措施

干预措施代码:

Intervention:

Non-Intervention Control

Intervention code:

组别:

阳虚血瘀型对照组

样本量:

30

Group:

Control Group with Yang Deficiency and Blood Stasis Pattern

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

Standard Treatment

Intervention code:

组别:

阴虚血瘀型对照组

样本量:

30

Group:

Control Group with Yin Deficiency and Blood Stasis Pattern

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

Standard Treatment

Intervention code:

组别:

气虚血瘀型对照组

样本量:

30

Group:

Control Group with Qi Deficiency and Blood Stasis Pattern

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

Standard Treatment

Intervention code:

样本总量 Total sample size : 210

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

CHINA

Province:

Zhejiang Province

City:

单位(医院):

浙江中医药大学附属宁波市中医院

单位级别:

三级甲等

Institution/hospital:

Ningbo Municipal Hospital of Traditional Chinese Medicine(TCM) Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

肾功能

指标类型:

主要指标

Outcome:

Renal function   肾功能

Type:

Primary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标

Outcome:

Hepatic Function Panel   肝功能检测面板

Type:

Adverse events

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

甲状旁腺激素

指标类型:

次要指标

Outcome:

Parathyroid Hormone   甲状旁腺激素

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清HIF-1α

指标类型:

附加指标

Outcome:

Serum Hypoxia-Inducible Factor 1-Alpha 血清缺氧诱导因子 1-α

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血磷

指标类型:

次要指标

Outcome:

Serum Phosphorus   血清磷

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清NGAL

指标类型:

附加指标

Outcome:

Serum Neutrophil Gelatinase-Associated Lipocalin 血清中性粒细胞明胶酶相关脂质运载蛋白

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血红蛋白

指标类型:

次要指标

Outcome:

Hemoglobin   血红蛋白

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

中医症状积分

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine (TCM) Symptom Score 中医症状评分

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血钙

指标类型:

次要指标

Outcome:

Serum Calcium   血清钙

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清代谢组

指标类型:

附加指标

Outcome:

Serum Metabolome   血清代谢组

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

尿蛋白/尿肌酐

指标类型:

次要指标

Outcome:

Urine Protein-to-Creatinine Ratio 尿蛋白与肌酐比值

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血脂

指标类型:

次要指标

Outcome:

Lipid Profile   血脂谱

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清ADMA

指标类型:

附加指标

Outcome:

Serum Asymmetric Dimethylarginine 血清非对称性精氨酸

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

三硫酸吲哚酚

指标类型:

附加指标

Outcome:

Indoxyl Sulfate   靛磺酸盐

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清FGF-23

指标类型:

附加指标

Outcome:

Serum Fibroblast Growth Factor 23 血清成纤维细胞生长因子 23

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清PAI-1

指标类型:

附加指标

Outcome:

Serum Plasminogen Activator Inhibitor-1 血清纤溶酶原激活剂抑制剂-1

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

三甲胺氧化物

指标类型:

附加指标

Outcome:

Trimethylamine N-Oxide   三甲胺 N-氧化物

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清α-SMA

指标类型:

附加指标

Outcome:

Serum Alpha-Smooth Muscle Actin 血清α-平滑肌肌动蛋白

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

硫酸对甲酚

指标类型:

附加指标

Outcome:

p-Cresyl Sulfate   对甲苯磺酸

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血钾

指标类型:

副作用指标

Outcome:

Serum Potassium   血清钾

Type:

Adverse events

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血白蛋白

指标类型:

次要指标

Outcome:

Serum Albumin   血清白蛋白

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清TGF-β1

指标类型:

附加指标

Outcome:

Serum Transforming Growth Factor Beta 1 血清转化生长因子β1

Type:

Additional indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

血清β微球蛋白

指标类型:

次要指标

Outcome:

Serum Beta Microglobulin 血清β微球蛋白

Type:

Secondary indicator

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

指标中文名:

心电图

指标类型:

副作用指标

Outcome:

Electrocardiogram   心电图

Type:

Adverse events

测量时间点:

治疗前,治疗4周后,治疗8周后

测量方法:

Measure time point of outcome:

Before treatment, 4 weeks after treatment, 8 weeks after treatment

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

组织:

Sample Name:

Urinary Specimen

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:

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 75
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):

由项目负责人采用随机数字表法,将符合研究标准的患者随机分配,每组30例

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

project leader allocated eligible patients (n=30 per group) using a random number table method

盲法:

Blinding:

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):

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

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:

经过培训的研究人员将在病例记录表中收集和记录数据,并使用医院电子数据采集系统进行数据管理和统计分析,所有保留的数据将被编码以识别患者,而不是个人信息。

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

Trained researchers will collect and record data in Case Record Form(CRF)and perform data management and statistical analysis using Hospital's Electronic Data Capture(EDC) and all retained data will be encoded to identify patients rather than personal information.

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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