软坚清脉颗粒治疗下肢动脉硬化闭塞症的随机对照研究

注册号:

Registration number:

ITMCTR2200005580

最近更新日期:

Date of Last Refreshed on:

2022-02-01

注册时间:

Date of Registration:

2022-02-01

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

软坚清脉颗粒治疗下肢动脉硬化闭塞症的随机对照研究

Public title:

A randomized controlled trial of Ruanjian Qingmai Granule in the treatment of peripheral arterial disease

注册题目简写:

English Acronym:

研究课题的正式科学名称:

软坚清脉法治疗下肢动脉硬化闭塞症的多中心临床研究

Scientific title:

A multi-center clinical trial of Ruanjian Qingmai Granule in the treatment of peripheral arterial disease

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:

ChiCTR2200056109 ; ChiMCTR2200005580

申请注册联系人:

梁新雨

研究负责人:

曹烨民

Applicant:

liang xinyu

Study leader:

cao yemin

申请注册联系人电话:

Applicant telephone:

13733166804

研究负责人电话:

Study leader's telephone:

13361831119

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:

1064321689@qq.com

研究负责人电子邮件:

Study leader's E-mail:

dr_cao@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:

上海市浦东新区张江高科华佗路280弄

研究负责人通讯地址:

上海市虹口区保定路230号

Applicant address:

Lane 280, Huatuo Road, Zhangjiang Gaoke, Pudong New Area, Shanghai

Study leader's address:

230 Baoding Road, Hongkou 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:

上海中医药大学

Applicant's institution:

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:

2021-015-1

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:

上海中医药大学附属上海市中西医结合医院伦理委员会

Name of the ethic committee:

IRB of shanghai TCM-Integrated Hospital, shanghai university of traditional chinese medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/11/15 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:

上海市中西医结合医院

Primary sponsor:

shanghai TCM-Integrated Hospital

研究实施负责(组长)单位地址:

上海市虹口区保定路230号

Primary sponsor's address:

230 Baoding Road, Hongkou 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):

上海市中西医结合医院

具体地址:

上海市虹口区保定路230号

Institution
hospital:

shanghai TCM-Integrated Hospital

Address:

230 Baoding Road, Hongkou District, Shanghai

经费或物资来源:

上海市2020年度“科技创新行动计划”医学创新研究专项

Source(s) of funding:

Medical innovation project of Shanghai 2020

研究疾病:

下肢动脉粥样硬化闭塞症

研究疾病代码:

Target disease:

peripheral arterial disease

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:

I期临床试验

Phase I clinical trial

研究目的:

探究软坚清脉颗粒对下肢动脉粥样硬化闭塞症患者步行能力的改善效果和安全性

Objectives of Study:

To explore the efficacy and safety of Renjian Qingmai granule on walking ability of patients with peripheral arterial disease related intermittent claudication

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)符合西医诊断标准;①年龄>40岁,有吸烟、糖尿病、高血压、高脂血症等高危因素,存在下肢缺血的临床表现,如间歇性跛行、患肢皮温下降、麻木、皮肤毛发脱落等患肢足背或胫后动脉搏动减弱或消失;②ABI≤0.9;③彩色多普勒超声、CTA、MRA或DSA等影像学检查显示相应下肢动脉的狭窄或闭塞等病变; (2)符合中医诊断标准(痰湿阻络证) 根据国家中医药管理局十一五重点专科外科协作组的脱疽未溃期的临床诊疗方案和中药新药临床指导原则-中医症候临床研究指导原则(2002版)的有关内容: 痰湿证:①肢体酸困;②肢体沉重;③下肢水肿; 血瘀证:主证:①下肢酸痛,皮色暗红或皮温低下;②间歇性跛行;③足背、胫后动脉搏动减弱或消失; 次证:患肢皮肤干燥脱屑,患肢发凉、麻木,足趾甲增厚,汗毛稀疏,患肢的抽痛、肌肉抽搐。 舌象:暗红,有瘀点或瘀斑;脉象:脉沉、涩。 具备血瘀证的主症,同时满足痰湿证和血瘀证中次症的任意一项,结合舌脉即可诊断。 (3)PAD分级属于Fontaine Ⅱ, Rutherford Ⅰ(1-3)的患者,临床表现以间歇性跛行为主且近 1月无明显加重; (4)40<年龄≤80岁,性别不限; (5)同意参加本临床试验并自愿签署知情同意书。

Inclusion criteria

(1) Meet diagnostic criteria of PAD: ① Age > 40 years old, with smoking, diabetes, hypertension, hyperlipidemia and other high-risk factors, there are clinical manifestations of lower limb ischemia, such as intermittent claudication, affected limb skin temperature drop, numbness, skin hair loss and other affected limb dorsal or posterior tibial artery pulse weakened or disappeared; ②ABI 0.9 or less; ③ Color Doppler ultrasound, CTA, MRA or DSA imaging examination showed stenosis or occlusion of the corresponding lower limb arteries; (2) Meet the diagnostic criteria of TCM (syndrome of phlegm-dampness blocking collaterals): Phlegm and dampness syndrome: sore and swollen, fatigued, swollen; Blood stasis syndrome: main syndrome: ① lower limb pain, dark red skin color or low skin temperature; ② Intermittent claudication; ③ The pulsatile of dorsalis pedalis and posterior tibial artery was weakened or disappeared; Secondary syndromes: The skin is dry and desquamate, the limbs are cool and numb, the toenails are thickened, the hair is sparse, and the limbs are throbbing and muscle twitching. Tongue image: dark red with petechiae; Pulse: heavy and astringent pulse. (3) Patients with PAD (Fontaine Ⅱ or Rutherford Ⅰ) showed intermittent claudication with no significant exacerbation in the recent one month; (4) 40 < age ≤80, no gender limitation; (5) The patients agreed to participate in the clinical trial and voluntarily signed the informed consent.

排除标准:

①存在影响行走距离的其他疾病,如下肢溃疡、坏疽、关节病变、脊柱病变、下肢静脉性疾病等; ②目前存在急性或严重肢端缺血者、计划进行下肢血管重建者以及存在截肢史的患者; ③近3个月内被诊断为不稳定心绞痛、心梗、心力衰竭(Ⅲ、Ⅳ)和短暂性脑缺血等心脑血管疾病者; ④血糖严重控制不良者(HbA1c>10.0%),血压严重控制不良者(收缩压≥160mmHg或舒张压≥100mmHg); ⑤股总以上、股髂动脉闭塞、腹股沟以上动脉闭塞的患者; ⑥炎症性血管疾病患者,如多发性大动脉炎、周围血管水肿、血栓闭塞性脉管炎等非下肢动脉粥样硬化闭塞症; ⑦存在肝肾功能异常者、恶行肿瘤、精神异常等研究者认为不适宜参加本研究的患者; ⑧既往对研究的任何药物或辅料过敏,或对其他同类产品有过敏史的患者; ⑨近6个月内参与过其它药物临床试验者。

Exclusion criteria:

① There are other diseases that affect the walking distance, such as lower limb ulcer, gangrene, arthropathy, spinal disease, lower limb venous disease, etc. ② Patients with acute or severe extremity ischemia, planned lower extremity vascular reconstruction, and a history of amputation; ③ Patients were diagnosed with unstable angina pectoris, myocardial infarction, heart failure (ⅲ, ⅳ) and transient cerebral ischemia within the last 3 months; ④ Patients with poor blood glucose control (HbA1c>10.0%) and poor blood pressure control (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg); ⑤ patients with femoral artery occlusion, femoral iliac artery occlusion and inguinal artery occlusion; ⑥ Patients with inflammatory vascular disease, such as multiple arteritis, peripheral vascular edema, thromboangiitis obliterans and other non-lower limb atherosclerosis obliterans diseases; ⑦ Patients with liver and kidney dysfunction, malignant tumors, mental abnormalities and other patients considered by researchers to be unsuitable to participate in this study; ⑧ Patients who have been allergic to any drugs or excipients in the study, or have been allergic to other similar products; ⑨ The patients who have participated in clinical trials of other drugs within the last 6 months.

研究实施时间:

Study execute time:

From 2022-04-01

To      2024-04-01

征募观察对象时间:

Recruiting time:

From 2022-04-01

To      2024-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

125

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

试验组

样本量:

125

Group:

treatment group

Sample size:

干预措施:

软坚清脉颗粒

干预措施代码:

Intervention:

Renjian Qingmai granule

Intervention code:

样本总量 Total sample size : 250

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):

Country:

china

Province:

shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等

Institution/hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution:

Grade 3, class A hospital

国家:

中国

省(直辖市):

上海

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

中山医院

单位级别:

三级甲等

Institution/hospital:

Zhongshan Hospital, Fudan university

Level of the institution:

Grade 3, class A hospital

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海市第六人民医院

单位级别:

三级甲等医院

Institution/hospital:

Shanghai Sixth People's Hospital

Level of the institution:

Grade 3, class A hospital

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海市中西医结合医院

单位级别:

三级甲等中医院

Institution/hospital:

shanghai TCM-Integrated Hospital

Level of the institution:

Grade 3, Class A hospital

测量指标:

Outcomes:

指标中文名:

生活质量评分

指标类型:

次要指标

Outcome:

quality of life,MOS SF-36

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标

Outcome:

adverse events

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候及主要症状

指标类型:

次要指标

Outcome:

TCM syndromes and main symptoms

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

踝肱指数

指标类型:

次要指标

Outcome:

ABI

Type:

Secondary indicator

测量时间点:

测量方法:

连续波多普勒超声仪器

Measure time point of outcome:

Measure method:

指标中文名:

无痛步行距离

指标类型:

主要指标

Outcome:

pain free walking distance

Type:

Primary indicator

测量时间点:

筛选期(-7天),基线(0天),8周(56天),16周(112天)

测量方法:

跑步机,设置为(3.2km/h,12%)

Measure time point of outcome:

Measure method:

指标中文名:

疼痛缓解的时间

指标类型:

附加指标

Outcome:

Time of pain relief when stop walking

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最大步行距离

指标类型:

主要指标

Outcome:

max walking distance

Type:

Primary indicator

测量时间点:

筛选期(-7天),基线(0天),8周(56天),16周(112天

测量方法:

跑步机,设置为(3.2km/h,12%)

Measure time point of outcome:

Measure method:

指标中文名:

行走障碍问卷

指标类型:

次要指标

Outcome:

the walking impairment questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛的程度

指标类型:

附加指标

Outcome:

The degree of pain induced by walking

Type:

Additional 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 40
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):

随机方法采用随机数字表法按顺序编码、密封、不透光的信封进行随机。对负责招募和评估受试者的研究人员隐藏分配序列,分配序列装于按顺序编码的密封、不透明的信封中。随机序列的产生由项目负责人负责,随机号跟随患者固定不变。研究药物经编盲后产生的编号为本试验的研究编号,研究人员按受试者的入组顺序分配随机编号,根据研究编号从小到大发放产品,不得跳号。该随机号在该受试者的整个研究过程中保持不变。

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

Random number table method is used to randomize sequentially coded, sealed, opaque envelopes. Hidden assignment sequences from researchers responsible for recruiting and evaluating subjects in sequentially encoded sealed, opaque envelopes. The generation of the random sequence is the responsibility of the project leader, and&#

盲法:

采用第三方评价的方法。实验指标检测有专人负责,数据收集与统计专人负责,检测者及统计人员均不知道试验分组及具体操作情况。指派2名不参与该项目治疗操作的人员,1名记录所有观察、评价指标,1名负责课题全过程的质量监控,另外资料的采集、保存和分析由经过培训的专人负责,治疗操作者不参与此项工作。

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):

2024/12/1,试验执行过程中,会实时上传至本地第三方数据管理平台,在本试验完成后,将原始数据上传到 ResMan,实现原始数据共享。

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

2024/12/1, Online platform(the web-based medical research public management platform ResMan)

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:

本试验采用电子采集管理系统(EDC)与病例记录表(CRF)相结合的方式。研究的主办单位(上海市中西医结合医院)采用电子采集管理系统(EDC)的方式记录原始数据,其余分中心采取病例记录表的形式记录原始数据,待本试验结束后,统一上传本地第三方数据管理平台,最后统一上传至于互联网的临床研究公共管理平台(ResMan)。

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

Electronic collection management system (EDC) and case record form (CRF) were used in this study. The sponsor of the study (shanghai TCM-Integrated Hospital) recorded the original data in the form of electronic Acquisition management System (EDC), while the other branches recorded the original data in the form of case records, which were uploaded to the local third-party data management platform after the end of the study. Finally, the original data was uploaded to the web-based medical research public management platform ResMan,an Electronic Data Capture (EDC).

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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