Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Venous Inflammation Granules Combined with External Application of Jinhuang Ointment in the Treatment of Acute Blood Heat Stasis Type Superficial Venous Thrombosis of the Lower Extremities:A Randomized Double-blind Placebo-controlled Clinical Study

注册号：

Registration number：

ITMCTR2025000525

最近更新日期：

Date of Last Refreshed on：

2025-03-13

注册时间：

Date of Registration：

2025-03-13

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

静脉炎颗粒联合金黄膏外敷治疗急性期血热瘀结型下肢血栓性浅静脉炎——一项随机、双盲、安慰剂对照临床研究

Public title：

Venous Inflammation Granules Combined with External Application of Jinhuang Ointment in the Treatment of Acute Blood Heat Stasis Type Superficial Venous Thrombosis of the Lower Extremities:A Randomized Double-blind Placebo-controlled Clinical Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

静脉炎颗粒治疗血栓性浅静脉炎急性期（血热瘀结证）有效性和安全性的随机、双盲、安慰剂对照、剂量探索、多中心Ⅱ期临床试验

Scientific title：

A Randomized Double-Blind Placebo-Controlled Dose-Finding Multicenter Phase II Clinical Trial on the Efficacy and Safety of Jingmaiyan Granules in the Treatment of Superficial Venous Thrombosis (Blood-Heat Stasis Syndrome)

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：

陈泓

研究负责人：

柳国斌

Applicant：

chenhong

Study leader：

liuguob

申请注册联系人电话：

Applicant telephone：

15320796585

研究负责人电话：

Study leader's telephone：

15800885533

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：

ch2750955690@163.com

研究负责人电子邮件：

Study leader's E-mail：

15800885533@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：

上海市浦东新区张衡路528号

研究负责人通讯地址：

上海市浦东新区张衡路528号

Applicant address：

No. 528 Zhangheng Road Pudong New District Shanghai China

Study leader's address：

No. 528 Zhangheng Road Pudong New District Shanghai China

申请注册联系人邮政编码：

Applicant postcode：

201203

研究负责人邮政编码：

Study leader's postcode：

201203

申请人所在单位：

上海中医药大学附属曙光医院

Applicant's institution：

Shanghai Shuguang Hospital Affiliated to 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：

2022-1209-146-02

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：

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/12/28 0:00:00

伦理委员会联系人：

马俊坚

Contact Name of the ethic committee：

majunjian

伦理委员会联系地址：

上海市张衡路 528号

Contact Address of the ethic committee：

No. 528 Zhangheng Road Pudong New District Shanghai China

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-20356070

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sByyllwyh@126.com

研究实施负责（组长）单位：

上海中医药大学附属曙光医院

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市浦东新区张衡路528号

Primary sponsor's address：

No. 528 Zhangheng Road Pudong New District Shanghai 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)：

上海

市(区县)：

上海

Country：

china

Province：

shanghai

City：

shanghai

单位(医院)：

上海中医药大学附属曙光医院

具体地址：

上海市浦东新区张衡路528号

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 528 Zhangheng Road Pudong New District Shanghai China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

下肢血栓性浅静脉炎

研究疾病代码：

Target disease：

Thrombotic Superficial Phlebitis of the Lower Limbs

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：

本研究旨在评估静脉炎颗粒联合金黄膏外敷对比单纯外敷治疗的临床疗效，重点关注急性期血热瘀结型ST患者的症状缓解（疼痛、皮温、条索结节）及中医证候积分改善。揭示联合治疗的生物学机制，通过分析全血黏度（高/中/低切变率）、血浆黏度及炎症标志物（CRP、IL-6、TNF-α）的动态变化，阐明中药复方对血液高凝状态及系统性炎症的调控作用。验证治疗安全性，系统记录不良事件（如肝肾功能异常、过敏反应），为临床推广提供循证依据。建立中西医结合标准化方案，填补血热瘀结型ST治疗中草药-外治联合疗法的高等级证据空白，推动中医药国际化进程。

Objectives of Study：

This study aims to evaluate the clinical efficacy of combining Phlebitis Granules with external application of Jinhuang Ointment compared to external application alone focusing on symptom relief (pain skin temperature cord-like nodules) and improvement in Traditional Chinese Medicine (TCM) syndrome scores in patients with acute blood-heat and stasis-type superficial thrombophlebitis (ST). The study seeks to uncover the biological mechanisms of the combined therapy by analyzing dynamic changes in whole blood viscosity (at high medium and low shear rates) plasma viscosity and inflammatory markers (CRP IL-6 TNF-α). It aims to elucidate the regulatory effects of TCM compound formulas on hypercoagulability and systemic inflammation. Additionallythe study will assess treatment safety by systematically recording adverse events (e.g. liver and kidney dysfunction allergic reactions) to provide evidence-based support for clinical application. By establishing a standardized integrative medicine protocol this research will fill the gap in high-level evidence for the combined herbal-external therapy in treating blood-heat and stasis-type ST contributing to the internationalization of Traditional Chinese Medicine.

药物成份或治疗方案详述：

观察组：采用金黄膏外敷加弹力绷带压力缠敷联合口服静脉炎颗粒（每袋5g，批号2021LP00353，江苏康缘药业股份有限公司；成份为金银花、垂盆草、赤芍、牡丹皮、熟大黄、甘草的喷干细粉、可溶性淀粉、糊精）口服，每次2袋，每日3次，饭后半小时温水送服，共2周。 对照组：采用金黄膏外敷加弹力绷带压力缠敷外加口服静脉炎颗粒安慰剂（成份为静脉炎颗粒喷干细粉的 5%、可溶性淀粉、色素、糊精）口服，每次2袋，每日3次，饭后半小时温水送服，共2周。研究期间禁止使用其他中药制剂。

Description for medicine or protocol of treatment in detail：

Observation Group:Patients in the observation group will receive external application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of Phlebitis Granules (5g per sachet batch number 2021LP00353 manufactured by Jiangsu Kanion Pharmaceutical Co. Ltd.). The granules contain spray-dried fine powder of Lonicera japonica (Honeysuckle) Sedum sarmentosum Paeonia rubra Moutan Cortex prepared Rheum officinale licorice soluble starch and dextrin. The dosage is 2 sachets per administration three times daily taken with warm water 30 minutes after meals for a total of 2 weeks. Control Group:Patients in the control group will receive external application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of a placebo for Phlebitis Granules. The placebo consists of 5% spray-dried fine powder of Phlebitis Granules soluble starch pigment and dextrin. The dosage regimen is identical to the observation group: 2 sachets per administration three times daily taken with warm water 30 minutes after meals for a total of 2 weeks.The use of other traditional Chinese medicine preparations is prohibited during the study period.

纳入标准：

下肢血栓性浅静脉炎的诊断标准参照《实用周围血管疾病学》和《欧洲血管外科学会（ESVS）2021年静脉血栓管理临床实践指南》拟定：症状表现为疼痛且触痛的肿块或条带，伴有发红和发热，位于已有静脉曲张的区域，特别是沿着大隐静脉 (GSV) 走向。或超声检查显示静脉内存在血栓、静脉壁增厚或有炎症反应。急性期血常规检查白细胞总数增高。 ST急性期血热瘀结型中医辨证标准参照《周围血管疾病中西医诊疗学》和《中医病证诊断疗效标准》拟定：局部硬结节或硬条索状物，皮肤色素沉着，针刺样疼痛，压痛，伴发红，肿胀，灼热。严重者在浅静脉周围出现大片红肿区。舌暗红，或有瘀斑、瘀点，苔黄腻，脉沉细涩。1）符合上述诊断及中医标准，年龄18-70岁之间，性别不限；2）单纯性下肢血栓性浅静脉炎或由原发性下肢静脉曲张导致；3）发病后未接受过相关治疗者；4）就诊时疼痛VAS评分整数分值≥40mm；5）自愿参与本研究并签署知情同意书。

Inclusion criteria

The diagnostic criteria for lower limb thrombotic superficial phlebitis are formulated with reference to Practical Peripheral Vascular Diseases and the 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis by the European Society for Vascular Surgery (ESVS). The condition is characterized by painful and tender nodules or cord-like structures accompanied by redness and warmth located in areas with pre-existing varicose veins particularly along the course of the great saphenous vein (GSV). Alternatively ultrasound examination may reveal the presence of thrombi within the vein thickening of the venous wall or inflammatory reactions. In the acute phase routine blood tests show an elevated white blood cell count.The Traditional Chinese Medicine (TCM) diagnostic criteria for the acute phase of blood-heat and blood stasis type ST are based on Integrated Diagnosis and Treatment of Peripheral Vascular Diseases in Traditional Chinese and Western Medicine and the TCM Syndrome Diagnosis and Efficacy Criteria. Symptoms include localized hard nodules or indurated cord-like structures skin pigmentation needle-like pain tenderness redness swelling and a burning sensation. In severe cases extensive red and swollen areas appear around the superficial veins. The tongue is dark red possibly with petechiae or ecchymosis and the coating is yellow and greasy. The pulse is deep thin and choppy.Inclusion Criteria:Meeting the above diagnostic and TCM criteria aged between 18 and 70 years with no gender restrictions. 18 70 Diagnosed with simple lower limb thrombotic superficial phlebitis or secondary to primary lower limb varicose veins.No prior treatment for the condition at the time of onset. A pain score of ≥40 mm on the Visual Analog Scale (VAS) at the time of consultation. Willing to participate in this study and providing signed informed consent.

排除标准：

1）游走性血栓性浅静脉炎；2）病变靶血管合并有活动性溃疡未愈合或其他需要外科处理的严重情况者；3）合并有深静脉血栓形成者；4）皮肤及软组织感染性疾病者，如丹毒、急性淋巴管炎、急性蜂窝织炎等；5）血常规中性粒细胞计数超过正常值上限者；6）Cr超过正常值上限或ALT、AST中任一项超过正常值上限1.5倍者；7）合并有心、肝、肾、造血系统等重要器官和系统严重原发性疾病者；8）妊娠期或半年内准备妊娠的妇女，哺乳期妇女；9）精神病患者或认知障碍者；10）对试验药物已知成份过敏或过敏体质者；11）怀疑或确认有酒精成瘾、药物滥用史者；12）筛选前30天内参加过其他临床试验者；13）研究者认为不适宜参加本临床试验者。

Exclusion criteria：

1) Migratory thrombophlebitis; 2) Target blood vessels with active ulcers that have not healed or other severe conditions requiring surgical intervention; 3) Concomitant deep vein thrombosis; 4) Infectious skin and soft tissue diseases such as erysipelas acute lymphangitis and acute cellulitis; 5) Neutrophil count exceeding the upper limit of normal in routine blood tests; 6) Serum creatinine (Cr) exceeding the upper limit of normal or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) exceeding 1.5 times the upper limit of normal; 7) Severe primary diseases of major organs or systems including the heart liver kidneys and hematopoietic system; 8) Pregnant women women planning pregnancy within six months or breastfeeding women; 9) Patients with psychiatric disorders or cognitive impairment; 10) Individuals with known allergies to the investigational drug components or those with a history of allergic constitution; 11) Suspected or confirmed history of alcohol addiction or substance abuse; 12) Participation in other clinical trials within 30 days prior to screening; 13) Individuals deemed unsuitable for this clinical trial by the investigator.

研究实施时间：

Study execute time：

从From 2023-12-31

至To      2024-11-22

征募观察对象时间：

Recruiting time：

从From 2023-12-31

至To      2024-11-22

干预措施：

Interventions：

组别：

对照组

样本量：

62

Group：

1

Sample size：

干预措施：

金黄膏外敷加弹力绷带压力缠敷外加口服静脉炎颗粒安慰剂

干预措施代码：

Intervention：

External application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of a placebo for Phlebitis Granules.

Intervention code：

组别：

观察组

样本量：

62

Group：

2

Sample size：

干预措施：

金黄膏外敷加弹力绷带压力缠敷联合口服静脉炎颗粒

干预措施代码：

Intervention：

External application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of Phlebitis Granules.

Intervention code：

样本总量 Total sample size ： 124

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)：

上海

Country：

china

Province：

shanghai

City：

shanghai

单位(医院)：

上海中医药大学附属曙光医院

单位级别：

三甲医院

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary Grade A Hospital

测量指标：

Outcomes：

指标中文名：

血液流变学

指标类型：

次要指标

Outcome：

Hematorheology

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝肾功能

指标类型：

副作用指标

Outcome：

Liver and kidney function

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤坏死因子-α

指标类型：

次要指标

Outcome：

Tumor Necrosis Factor-α

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VAS评分

指标类型：

次要指标

Outcome：

Pain VAS (Visual Analog Scale) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

白介素-6

指标类型：

次要指标

Outcome：

Interleukin-6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

证候评分

指标类型：

次要指标

Outcome：

Syndrome score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

C反应蛋白

指标类型：

次要指标

Outcome：

C-Reactive Protein

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床疗效

指标类型：

主要指标

Outcome：

Clinical efficacy

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：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 70 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）：

本研究采用简单随机化，利用统计软件SPSS 28.0版本生成1-124的随机数字，将各随机号制成卡片采用不透光信封密闭，由专门人员保管，并按每位患者就诊顺序进行发放，将患者随机分为观察组和对照组各62例，使用相对应编号的药物。

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

This study used simple randomization with statistical software SPSS version 28.0 to generate random numbers from 1 to 124. These random numbers were printed on cards and sealed in opaque envelopes which were stored by designated personnel. The cards were distributed according to the order of patient visits and patients were randomly assigned to either the observation group or the control group with 62 cases in each group. The corresponding medications were used according to the assigned numbers.

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）：

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）： 2025年3月，国际传统医学实验注册平台，http://itmctr.ccebtcm.org.cn/

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

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)： In March 2025 the International Traditional Medicine Experiment Registration Platform http://itmctr.ccebtcm.org.cn/

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：

CRF

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

CRF

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above