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Randomized and controlled clinical trials based on the "muscle controlled by the spleen" to explore the safety and effectiveness of Shen-ling-bai-zhu-san in the treatment of COPD with myolemia.

注册号：

Registration number：

ITMCTR2025000699

最近更新日期：

Date of Last Refreshed on：

2025-04-11

注册时间：

Date of Registration：

2025-04-11

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于“脾主肌肉”探讨参苓白术散治疗COPD合并肌少症安全性和有效性的随机、对照临床试验

Public title：

Randomized and controlled clinical trials based on the "muscle controlled by the spleen" to explore the safety and effectiveness of Shen-ling-bai-zhu-san in the treatment of COPD with myolemia.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“脾主肌肉”探讨参苓白术散治疗COPD合并肌少症安全性和有效性的随机、对照临床试验

Scientific title：

Randomized and controlled clinical trials based on the "muscle controlled by the spleen" to explore the safety and effectiveness of Shen-ling-bai-zhu-san in the treatment of COPD with myolemia.

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：

刘超

研究负责人：

曾珠

Applicant：

Liuchao

Study leader：

Zengzhu

申请注册联系人电话：

Applicant telephone：

13628005045

研究负责人电话：

Study leader's telephone：

15184443280

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：

liuchao@stu.cdutcm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zengzhu@cdutcm.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：

四川省成都市金牛区十二桥路37号

研究负责人通讯地址：

四川省成都市金牛区十二桥路39号

Applicant address：

No. 37 Shi-er-qiao Road Chengdu 610072 Sichuan Province P. R. China

Study leader's address：

No. 39 Shi-er-qiao Road Chengdu 610072 Sichuan Province P. R. 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：

成都中医药大学临床医学院

Applicant's institution：

School of Clinical Medicine, Chengdu University of CM

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：

2024KL-088

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：

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee：

The Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/26 0:00:00

伦理委员会联系人：

王艳桥

Contact Name of the ethic committee：

Wang yanqiao

伦理委员会联系地址：

四川省成都市金牛区十二桥路39号

Contact Address of the ethic committee：

No. 39 Shi-er-qiao Road Chengdu 610072 Sichuan Province P. R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

028-87783139

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ethicscd@126.com

研究实施负责（组长）单位：

成都中医药大学附属医院

Primary sponsor：

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路39号

Primary sponsor's address：

No. 39 Shi-er-qiao Road Chengdu 610072 Sichuan Province P. R. 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

具体地址：

四川省成都市金牛区十二桥路39号

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Address：

No. 39 Shi-er-qiao Road Chengdu 610072 Sichuan Province P. R. China

经费或物资来源：

2022年度成都中医药大学〝杏林学者"学科人才 科研提升计划项目

Source(s) of funding：

2022 Chengdu University of Traditional Chinese Medicine "Xinglin Scholar" Discipline Talent Scientific Research Improvement Plan Project

研究疾病：

慢性阻塞性肺疾病合并肌少症

研究疾病代码：

Target disease：

COPD with sarcopenia

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

对COPD患者进行肌少症的早期筛查，并及早给予积极有效干预措施，对疾病转归和预后改善具有重大的临床意义。慢性阻塞性肺疾病是一种常见的、可预防和治疗的慢性气道疾病，其患病率高、死亡率高、致残率高、疾病负担重，已成为严重危害公众健康的重大慢性疾病。我国40岁以上人群患病率为13.7％，有近1亿COPD患者，居我国疾病死亡原因的第3位，而其疾病负担已居我国疾病的第2位，防治形势日益严峻。肌少症是一种以骨骼肌质量下降和功能减退为特点的退行性疾病，是COPD重要合并症，也是COPD预后不良的独立危险因素，迄今尚无特异治疗方法。研究表明，COPD患者50岁之后每年肌力下降1.5%～3.0%，肌肉减少1%～2%。15%～40%的COPD患者合并有肌少症，而随着COPD疾病的进展，患者呼吸困难逐渐加重，活动耐量随之减少，肌肉质量和力量也会下降，而肌少症也会加剧肺功能的恶化，从而导致运动能力下降，形成恶性循环。因此，对COPD患者进行肌少症的早期筛查，并及早给予积极有效干预措施，对疾病转归和预后改善具有重大的临床意义。 证实参苓白术散异病同治治疗COPD合并肌少症的临床疗效并揭示其作用机制，能为临床推广应用提供重要科学支撑。 参苓白术散在临床上被广泛运用于治疗COPD稳定期，可以改善患者肺功能及生活质量，同时也被证实可以增强肌少症的握力，增加肌量，但尚缺乏COPD合并肌少症患者中的相关临床和实验研究。本项目拟通过随机对照临床试验证实参苓白术散治疗COPD合并肌少症的有效性，同时通过网络药理学初步揭示其作用机制，能为其临床推广应用提供有力证据和科学支撑。 论证参苓白术散通过培土生金法治疗COPD合并肌少症的临床疗效，丰富了 “脾主肌肉”藏象理论的科学内涵。 COPD多归属于中医“肺胀”范畴，而肌少症归于“痿证”范畴，中医临床证实两者的病机演变多为肺脾两虚。脾胃为后天之本，气血生化之源，五脏六腑、四肢之精气皆源于脾胃。脾胃虚损，五脏相关，脾虚胃弱、气血不能运行四肢，则四肢萎软乏力。因此治疗当以补肺健脾为主，以培土生金为治则。参苓白术散出自《太平惠民和剂局方》，是培土生金法的代表方剂。本项目基于COPD合并肌少症“肺脾两虚”病机观，提出培土生金的治疗原则，证实参苓白术散通过补肺健脾干预COPD合并肌少症的临床疗效，丰富了“脾主肌肉”藏象理论的科学内涵。

Objectives of Study：

Early screening of COPD patients for myopenia and early active and effective intervention measures are of great clinical significance for disease return and prognosis improvement. Chronic obstructive pulmonary disease is a common preventable and treatable chronic airway disease. With its high prevalence high mortality rate high disability rate and heavy disease burden it has become a major chronic disease that seriously endangers public health. The prevalence of people over 40 years old in China is 13.7% with nearly 100 million COPD patients ranking third in the cause of death from disease in China and the burden of disease has ranked second in China's disease and the prevention and treatment situation is getting more and more serious. Myosis is a degenerative disease characterized by decreased skeletal muscle mass and hypofunction. It is an important comorbidity of COPD and an independent risk factor for poor prognosis of COPD. So far there is no specific treatment. Research shows that COPD patients' muscle strength decreases by 1.5% to 3.0% and muscle decreases by 1% to 2% every year after the age of 50 [5]. 15% to 40% of COPD patients have myasthenia and with the progression of COPD disease patients' dyspnea gradually worsens their activity tolerance decreases muscle mass and strength will also decline and myasthenia will also aggravate the deterioration of lung function resulting in a decline in motor ability and forming a vicious circle. Therefore early screening of COPD patients for myomyosis and early active and effective intervention measures are of great clinical significance for disease return and prognosis improvement.It confirms the clinical efficacy of ginseng white surgery in the treatment of COPD combined with myosthenia and reveals its mechanism of action which can provide important scientific support for clinical promotion and application. Shenling Baishusan is widely used in clinical practice to treat the stable period of COPD which can improve the lung function and quality of life of patients. At the same time it has been proven to enhance the grip of myomyosis and increase muscle mass. However there is still a lack of relevant clinical and experimental studies in patients with COPD and myosthenia. This project intends to confirm the effectiveness of ginseng in the treatment of COPD combined with myasthenia through randomized controlled clinical trials. At the same time its mechanism of action is preliminarily revealed through online pharmacology which can provide strong evidence and scientific support for its clinical promotion and application. It is proved that the clinical efficacy of Shenling Baishusan in the treatment of COPD combined with myasthenia through the cultured gold method enriches the scientific connotation of the Tibetan elephant theory of "spleen main muscle". COPD mostly belongs to the category of "pulmonary distension" in traditional Chinese medicine while myasthenia belongs to the category of "impotence syndrome". Traditional Chinese medicine clinically confirms that the evolution of the two is mostly lung and spleen deficiency. The spleen and stomach are the source of qi and blood biochemicals. The essence of the five organs and limbs comes from the spleen and stomach. The spleen and stomach are damaged and the five organs are related. The spleen and stomach are weak and the qi and blood cannot run the limbs so the limbs are weak. Therefore the treatment should be based on toning the lungs and strengthening the spleen and the treatment should be based on cultivating soil and making gold. Shenling Baishu San comes from the "Taiping Huimin He Agent Bureau" which is the representative formula of cultivating local gold. Based on the disease concept of "lung and spleen deficiency" with COPD combined with muscle glysis this project puts forward the treatment principle of cultivating soil and making gold. It confirms that the clinical effect of ginseng white surgery to intervenes with COPD combined with myasthenia by strengthening the lungs and spleen and enriches the scientific connotation of the Tibetan elephant theory of "spleen main muscle".

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）符合上述诊断标准者均可作为试验病例。 （2）年龄在 40～80岁之间。 （3）处于稳定期的 COPD 患者且近4周无急性加重史。 （4）能完成肺功能测定者。 （5）已签署知情同意书者，自愿参加本试验。

Inclusion criteria

(1) Those who meet the above diagnostic criteria can be regarded as test cases. (2) The age is between 40 and 80 years old. (3) Patients with COPD in a stable period and no history of acute aggravation in the past 4 weeks. (4) Those who can complete the lung function measurement. (5) Those who have signed the informed consent form voluntarily participate in this experiment.

排除标准：

(1)受试者正在怀孕、哺乳或计划怀孕； 2)≤4周前完成抗生素和/或类固醇治疗的活动性肺部感染或既往肺部感染； (3)合并已知的肺部其他严重疾病，包括哮喘、活动性肺结核、临床显著的支气管扩张、支气管哮喘、肺癌、气胸等； (4)合并心、肝肾及造血系统等严重原发病、精神病或其他任何研究者认为可能威胁患者安全，干扰评估或妨碍研究完成者； (5)对任何研究药物或类似化学分类药物过敏的患者； (6)无法成功使用干粉吸入器或无法进行肺功能测定的患者； (7)正在参与其他临床试验者。

Exclusion criteria：

(1) The subject is pregnant breastfeeding or planning to become pregnant; 2) Active lung infection or past lung infection that has been treated with antibiotics and/or steroids before ≤4 weeks; (3) Combined with other known serious lung diseases including asthma active tuberculosis clinically significant bronchiectasis bronchial asthma lung cancer pneumothorax etc.; (4) Combined with severe primary diseases such as heart liver kidney and hematopoietic systems mental illness or any other researcher believes may threaten the patient's safety interfere with the evaluation or hinder the completion of the study; (5) Patients who are allergic to any research drugs or similar chemically classified drugs; (6) Patients who cannot successfully use a dry powder inhaler or cannot perform lung function measurement; (7) Those who are participating in other clinical trials.

研究实施时间：

Study execute time：

从From 2024-07-28

至To      2026-04-01

征募观察对象时间：

Recruiting time：

从From 2024-07-30

至To      2025-07-01

干预措施：

Interventions：

组别：

实验组（参苓白术散）

样本量：

40

Group：

Experimental group

Sample size：

干预措施：

口服参苓白术散临方制剂

干预措施代码：

Intervention：

Senling Baizhu San

Intervention code：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

空白对照，即不予以任何中药治疗

干预措施代码：

Intervention：

Blank control, that is, no traditional Chinese medicine treatment is given.

Intervention code：

样本总量 Total sample size ： 80

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

sichuan

City：

chengdu

单位(医院)：

成都中医药大学附属医院

单位级别：

三甲医院

Institution/hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Three-A Hospital

测量指标：

Outcomes：

指标中文名：

圣乔治呼吸问卷积分

指标类型：

次要指标

Outcome：

St. Georges Respiratory Questionnaire SGRQ

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

COPD 患者自我评估测试问卷积分

指标类型：

次要指标

Outcome：

COPD assessment test，CAT

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床慢性阻塞性肺疾患调查问卷

指标类型：

次要指标

Outcome：

Clinical COPD Questionnaire，CCQ

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能

指标类型：

主要指标

Outcome：

pulmonary 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：

呼吸困难问卷评分

指标类型：

次要指标

Outcome：

modified Medical Research Council Dyspnea Scale，mMRC

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

BODE指数

指标类型：

次要指标

Outcome：

BODE

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

握力

指标类型：

主要指标

Outcome：

hand grip strength,HGS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

步行速度

指标类型：

主要指标

Outcome：

Walking speed

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6分钟步行试验

指标类型：

次要指标

Outcome：

6-minute walk test (6MWT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

骨骼肌指数（四肢）

指标类型：

主要指标

Outcome：

Skeletal Muscle Mass Index，SMI）

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：

无特殊标本，属于体外检查

组织：

无

Sample Name：

There are no special specimens, and it belongs to in vitro examination.

Tissue：

no

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 40 岁
Min age years
最大 80 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）：

通过随机数字表生成随机序列，随机号密封保存、专人管理，根据随机化方案对药品进行编码，按顺序号依次纳入受试者，分别进入治疗组和对照组。

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

Random sequences are generated through the random number table and the random number is sealed and stored by a special person. The drugs are coded according to the randomization scheme and the subjects are included in order according to the sequence numbers and they are entered into the treatment group and the control group respectively.

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）：

纸质文件

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

Paper documents

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：

一：病例记录表（已制作完成） 二：电子采集和管理系统（ResMan）

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

First: Case record form (completed) Second: Electronic Acquisition and Management System (ResMan)

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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