金橘方治疗肺部纯磨玻璃结节的前瞻性、开放标签、随机对照研究

注册号:

Registration number:

ITMCTR2025000252

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

金橘方治疗肺部纯磨玻璃结节的前瞻性、开放标签、随机对照研究

Public title:

Prospective open label randomized controlled study on the treatment of pure ground glass nodules in the lungs with Jinju formula

注册题目简写:

English Acronym:

研究课题的正式科学名称:

金橘方治疗肺部纯磨玻璃结节的前瞻性、开放标签、随机对照研究

Scientific title:

Prospective open label randomized controlled study on the treatment of pure ground glass nodules in the lungs with Jinju formula

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:

姚曼

研究负责人:

翟笑枫

Applicant:

Yao Man

Study leader:

Zhai Xiaofeng

申请注册联系人电话:

Applicant telephone:

15721571156

研究负责人电话:

Study leader's telephone:

13917595511

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:

yaomanyyx@163.com

研究负责人电子邮件:

Study leader's E-mail:

zhaixfch@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:

上海市杨浦区长海路168号

研究负责人通讯地址:

上海市杨浦区长海路168号

Applicant address:

No. 168 Changhai Road Yangpu District Shanghai

Study leader's address:

No. 168 Changhai Road Yangpu 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:

海军军医大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Naval 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:

CHEC2024-360

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:

上海长海医院医学伦理委员会

Name of the ethic committee:

Shanghai Changhai Hospital Medical Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/28 0:00:00

伦理委员会联系人:

何雅琪

Contact Name of the ethic committee:

He Yaqi

伦理委员会联系地址:

上海市杨浦区长海路168号

Contact Address of the ethic committee:

No. 168 Changhai Road Yangpu District Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

86-21-31162338

伦理委员会联系人邮箱:

Contact email of the ethic committee:

changhaiec@126.com

研究实施负责(组长)单位:

海军军医大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Naval Medical University

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号

Primary sponsor's address:

No. 168 Changhai Road Yangpu 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

海军军医大学第一附属医院

具体地址:

上海市杨浦区长海路168号

Institution
hospital:

The First Affiliated Hospital of Naval Medical University

Address:

No. 168 Changhai Road Yangpu District Shanghai

经费或物资来源:

上海市区级课题

Source(s) of funding:

District level projects

研究疾病:

肺结节

研究疾病代码:

Target disease:

Pulmonary nodule

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:

探索全国名中医凌昌全教授金橘方治疗肺纯磨玻璃结节的疗效及安全性。

Objectives of Study:

Exploring the efficacy and safety of Professor Ling Changquan's Golden Orange Formula in treating pure ground glass nodules in the lungs a nationally renowned traditional Chinese medicine practitioner.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

在筛选观察前21天中满足以下所有标准的患者将被纳入研究: (1)性别不限,年龄18—80岁之间; (2)初次发现肺结节时间在3个月以内,能提供胸部CT检查结果提示:5mm<肺纯磨玻璃结节≤10mm;单发或多发,如果多发,肺结节个数不超过10个,且以最大结节进行评估; (3)近3月内结节稳定无增长或消散; (4)自愿参加试验并签署知情同意书。

Inclusion criteria

Patients who meet all of the following criteria within 21 days prior to screening observation will be included in the study: (1) Gender not limited age between 18-80 years old; (2) The first discovery of pulmonary nodules within 3 months can provide chest CT examination results indicating: 5mm < pure ground glass nodules ≤ 10mm; Single or multiple if multiple with no more than 10 pulmonary nodules and evaluated based on the largest nodule; (3) The nodules have remained stable without growth or dissipation within the past three months; (4) Voluntarily participate in the experiment and sign the informed consent form.

排除标准:

在筛查和观察前21天中符合以下标准之一的患者将被排除在研究之外: (1)患有其他原发恶性肿瘤患者; (2)确诊为肺结核、肺真菌病、肺炎或其他病因明确的肺部疾病,目前或需 要立即进行抗结核、抗真菌、抗感染或其他相关治疗者; (3)肺部CT可直接观察到毛刺、分叶、血管集束影、空泡、胸膜牵拉、非实性结节中实性成分增加等恶性征象; (4)中医证候判断脾肾阳虚者; (5)心、肝、肾等患有严重疾病或功能严重障碍者; (6)妊娠或哺乳期妇女; (7)有精神或认知障碍者; (8)正在参加其他药物试验者; (9)对本研究药物过敏者。

Exclusion criteria:

Patients who meet one of the following criteria within 21 days prior to screening and observation will be excluded from the study: (1) Patients with other primary malignant tumors; (2) Diagnosed with pulmonary tuberculosis pulmonary fungal disease pneumonia or other lung diseases with clear causes currently may require Those who need to undergo immediate anti tuberculosis anti fungal anti infection or other related treatments; (3) Lung CT can directly observe malignant signs such as spicules lobulation vascular bundle shadows vacuoles pleural traction and increased solid components in non solid nodules; (4) Diagnosis of spleen kidney yang deficiency based on traditional Chinese medicine syndromes; (5) Individuals with serious illnesses or functional disorders of the heart liver kidneys etc; (6) Pregnant or lactating women; (7) Individuals with mental or cognitive impairments; (8) Participants in other drug trials; (9) Individuals who are allergic to the drugs used in this study.

研究实施时间:

Study execute time:

From 2024-11-01

To      2025-11-01

征募观察对象时间:

Recruiting time:

From 2024-11-01

To      2025-11-01

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Test group

Sample size:

干预措施:

中草药金橘方加减口服

干预措施代码:

Intervention:

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

临床观察

干预措施代码:

Intervention:

Clinical observation

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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

海军军医大学第一附属医院

单位级别:

Institution/hospital:

The First Affiliated Hospital of Naval Medical University

Level of the institution:

测量指标:

Outcomes:

指标中文名:

肿瘤标记物较基线变化

指标类型:

次要指标

Outcome:

Changes in tumor markers compared to baseline

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效判定

指标类型:

次要指标

Outcome:

Evaluation of Traditional Chinese Medicine Syndrome Efficacy

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总有效率

指标类型:

主要指标

Outcome:

Total efficiency

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶变风险积分判定

指标类型:

次要指标

Outcome:

Risk score determination for malignant transformation

Type:

Secondary 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:

正在进行

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):

由研究医生使用随机系统产生随机系列

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

A random series was generated by the study doctor using a random system

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):

学术文章发表

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

Publication of academic articles

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:

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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