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Clinical Study on Tongluo Huoxue Formula in the Treatment of Complications after Minimally Invasive Surgery for Lower Extremity Varicose Veins

注册号：

Registration number：

ITMCTR2025001200

最近更新日期：

Date of Last Refreshed on：

2025-06-17

注册时间：

Date of Registration：

2025-06-17

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

通络活血方治疗下肢静脉曲张微创术后并发症的临床研究

Public title：

Clinical Study on Tongluo Huoxue Formula in the Treatment of Complications after Minimally Invasive Surgery for Lower Extremity Varicose Veins

注册题目简写：

English Acronym：

研究课题的正式科学名称：

通络活血方治疗下肢静脉曲张微创术后并发症的临床研究

Scientific title：

Clinical Study on Tongluo Huoxue Formula in the Treatment of Complications after Minimally Invasive Surgery for Lower Extremity Varicose Veins

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：

周宇

研究负责人：

黄毅

Applicant：

yu zhou

Study leader：

yi huang

申请注册联系人电话：

Applicant telephone：

18252057957

研究负责人电话：

Study leader's telephone：

1392743305

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：

1829537572@qq.com

研究负责人电子邮件：

Study leader's E-mail：

Yihuang99@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：

上海市普陀区兰溪路164号普陀区中心医院

研究负责人通讯地址：

上海市普陀区兰溪路164号普陀区中心医院

Applicant address：

No. 164 Lanxi Road Putuo District Center Hospital Putuo District Shanghai

Study leader's address：

No. 164 Lanxi Road Putuo District Center Hospital Putuo 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：

普陀区中心医院

Applicant's institution：

Putuo District Center Hospital

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：

PTEC-A-2025-21-1

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：

上海市普陀区中心医院（上海中医药大学附属普陀医院）伦理委员会

Name of the ethic committee：

Ethics Committee of Putuo District Center Hospital Shanghai（Putuo HospitalShanghai University of Traditional Chinese Medicine）

伦理委员会批准日期：

Date of approved by ethic committee：

2025/5/16 0:00:00

伦理委员会联系人：

潘珊珊

Contact Name of the ethic committee：

shanshan pan

伦理委员会联系地址：

上海市普陀区兰溪路164号普陀区中心医院

Contact Address of the ethic committee：

No. 164 Lanxi Road Putuo District Center Hospital Putuo District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-22234110

伦理委员会联系人邮箱：

Contact email of the ethic committee：

xlt8171@126.com

研究实施负责（组长）单位：

普陀区中心医院

Primary sponsor：

Putuo District Center Hospital

研究实施负责（组长）单位地址：

上海市普陀区兰溪路164号普陀区中心医院

Primary sponsor's address：

No. 164 Lanxi Road Putuo District Center Hospital Putuo 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)：

普陀区

Country：

China

Province：

Shanghai

City：

Putuo District

单位(医院)：

普陀区中心医院

具体地址：

上海市普陀区兰溪路164号普陀区中心医院

Institution
hospital：

Putuo District Center Hospital

Address：

No. 164 Lanxi Road Putuo District Center Hospital Putuo District Shanghai

经费或物资来源：

普陀区中心医院

Source(s) of funding：

Putuo District Center Hospital

研究疾病：

下肢静脉曲张

研究疾病代码：

Target disease：

Lower Extremity Varicose Veins

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：

采用前瞻性、随机、平行对照的研究，通过评估患者疼痛、水肿、炎症指标，探讨通络活血方辅助治疗静脉曲张微创术后并发症的临床意义，为微创术后并发症的治疗提供合理的中医中药方案。

Objectives of Study：

A prospective randomized parallel-controlled study was conducted. By evaluating patients' pain edema and inflammatory indicators this study explored the clinical significance of Tongluo Huoxue Formula as an adjuvant therapy for complications after minimally invasive surgery for varicose veins aiming to provide a reasonable traditional Chinese medicine (TCM) regimen for the treatment of postoperative complications following minimally invasive procedures.

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术前符合下肢大隐静脉曲张的诊断标准，CEAP 分级属 C2~C6 级，已于我科行静脉激光闭合术者联合硬化剂治疗者； ②符合中医诊断标准及证型者； ③年龄 60~75 岁者，性别不限； ④如合并高血压病，血压控制稳定者（＜140/90mmHg）； ⑤如合并糖尿病，血糖控制稳定者（<11.1mmol/L）； ⑥对本研究知情，并愿意签署同意书者。 如以上任何一个条件为“否”，此研究参与者不可参与试验。

Inclusion criteria

① Preoperative patients who meet the diagnostic criteria for lower extremity great saphenous varicose veins with CEAP classification ranging from C2 to C6 and have undergone combined endovenous laser closure and sclerotherapy in our department; ② Patients who meet the TCM diagnostic criteria and syndrome types; ③ Patients aged 60 to 75 years regardless of gender; ④ Patients with hypertension whose blood pressure is stably controlled (<140/90 mmHg); ⑤ Patients with diabetes whose blood glucose is stably controlled (<11.1 mmol/L); ⑥ Patients who are informed about the study and willing to sign the informed consent form. Exclusion Criteria: If any of the above criteria is "no" the participant is ineligible for the trial.

排除标准：

①合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病,精神病患者，肿瘤或艾滋病患者；血肌酐、血尿素氮＞正常值上限；ALT ＞正常值上限；有临床意义的心律失常；术前下肢静脉造影造影提示深静脉血栓者；合并下肢静脉溃疡者；合并凝血功能异常者或自身免疫性疾病者； ②妊娠或哺乳期妇女,过敏体质或肝功能异常者； ③合并严重感染，病情危重者； ④合并糖尿病，血糖控制不稳定者（≥11.1mmol/L）； ⑤合并高血压病，血压控制不稳定者（≥140/90mmHg）； ⑥不符合纳入标准，未按规定用药，无法判断疗效，或资料不全等影响疗效或安全性判断者； ⑦根据研究者判断，具有降低入组可能性或使入组复杂化的其他病史，如工作环境经常变动，容易造成失访的情况； ⑧正在参加其他药物临床研究的研究参与者。

Exclusion criteria：

① Patients with severe primary diseases of the cardiovascular cerebrovascular liver kidney and hematopoietic systems psychiatric disorders tumors or AIDS; those with serum creatinine or blood urea nitrogen > upper limit of normal value; ALT > upper limit of normal value; clinically significant arrhythmia; deep vein thrombosis indicated by preoperative lower extremity venography; lower extremity venous ulcers; coagulation dysfunction or autoimmune diseases; ② Pregnant or lactating women individuals with allergic constitution or abnormal liver function; ③ Patients with severe infections or critical conditions; ④ Patients with diabetes mellitus and unstable blood glucose control (≥11.1 mmol/L); ⑤ Patients with hypertension and unstable blood pressure control (≥140/90 mmHg); ⑥ Individuals who do not meet the inclusion criteria fail to take medications as prescribed cannot have their efficacy evaluated or have incomplete data affecting the evaluation of efficacy or safety; ⑦ Individuals with other medical histories that in the judgment of the investigator reduce the possibility of enrollment or complicate enrollment such as frequent changes in work environment prone to loss to follow-up; ⑧ Study participants currently enrolled in other clinical drug trials.

研究实施时间：

Study execute time：

从From 2025-05-12

至To      2026-05-30

征募观察对象时间：

Recruiting time：

从From 2025-06-19

至To      2026-05-14

干预措施：

Interventions：

组别：

治疗组

样本量：

32

Group：

Treatment Group

Sample size：

干预措施：

①爱脉朗（柑橘黄酮片） 每日2次，每次1片。术后第1天开始使用，共14日。②通络活血方 :每日2次，每次1剂，水煎服，早晚分服 术后第1天开始使用，共14日

干预措施代码：

Intervention：

Alvenor (Citrus Flavonoid Tablets). Dosage: 1 tablet twice daily. Administration starts on the first day postoperatively for a total of 14 days.② Tongluo Huoxue Formula Administration: 1 dose twice daily, decocted in water for oral administration, taken in the morning and evening respectively. - Usage start: Commence from the 1st day post-surgery. - Treatment course: For a total of 14 days.

Intervention code：

组别：

对照组

样本量：

32

Group：

Control Group

Sample size：

干预措施：

爱脉朗（柑橘黄酮片），每片含3柑橘黄酮500mg，其中90%地奥司明450mg，10%橙皮苷60mg。生产厂家为法国施维雅药厂，批准文号国药准字J20140129 每日2次，每次1片。术后第1天开始使用，共14日。

干预措施代码：

Intervention：

Alvenor (Citrus Flavonoid Tablets). Each tablet contains 500 mg of citrus flavonoids including 450 mg of diosmin (90%) and 60 mg of hesperidin (10%). Manufactured by Servier (France) approved under the drug license number Guoyao Zhunzi J20140129. Dosage: 1 tablet twice daily. Administration starts on the first day postoperatively for a total of 14 days.

Intervention code：

样本总量 Total sample size ： 64

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)：

普陀区

Country：

China

Province：

shang hai

City：

Putuo District

单位(医院)：

普陀区中心医院

单位级别：

三级乙等

Institution/hospital：

Putuo District Center Hospital

Level of the institution：

Class III Grade B Hospital

测量指标：

Outcomes：

指标中文名：

中医临床症状积分：参考静脉疾病临床严重程度评分(VCSS)及静脉疾病致残评分(VDS)，拟中医临床症状积分表以多方面评价治疗前后下肢红、肿、热、痛、硬索或结节状物的症状及体征，比较手术前、术后3d、术后7d、术后2w时的差别

指标类型：

次要指标

Outcome：

Referencing the Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS) a TCM clinical symptom score table was designed to comprehensively evaluate symptoms and signs of lower extremity redness swelling heat pain hard cords or nodular lesions before and after treatment and compare differences at pre-operation 3 days postoperatively 7 days postoperatively and 2 weeks postoperatively.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疗效指标 痊愈：筋脉硬索结节消退；疗效指数为90%~100% 显效：筋脉硬索或结节大部分消退；疗效指数为60%~90% 有效：筋脉硬索或结节未完全消退；疗效指数为30%~60% 无效：筋脉硬索或结节增大破溃或无消退。疗效指数为30%以下

指标类型：

主要指标

Outcome：

Efficacy Evaluation Criteria: Cure: Complete resolution of tendon-vein hard nodules with an efficacy index of 90%-100%. Marked Effect: Substantial subsidence of hard cords/nodules efficacy index 60%-90%. Effective: Partial resolution of hard cords/nodules efficacy index 30%-60%. Ineffective: Nodules increase in size ulcerate or show no change efficacy index <30%.

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：

尚未开始

Not yet recruiting

年龄范围：

最小 60 岁
Min age years
最大 75 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）：

采用SPSS 26.0统计学软件，制作随机数字表，将全部入选患者按就诊顺序编号，随机分入治疗组与对照组

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

The SPSS 26.0 statistical software was used to generate a random number table. All enrolled patients were numbered in the order of their visit and randomly assigned to the treatment group or the control group.

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）：

不共享

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

no

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：

项目组质控人员或监查员需检查研究的进行是否遵循试验方案。 试验过程中要定期核查研究参与者的知情同意及筛选纳入情况；确认所有数据记录填写正确，并与原始资料一致；所有错误或遗漏均已改正或注明，经研究者签名并注明日期；研究参与者在研相关特殊情况应确认并记录；确认所有不良事件均应记录在案，严重不良事件在规定时间内作出报告、记录在案并及时处理等。

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

The quality control personnel or monitors of the project team shall inspect whether the study is conducted in compliance with the trial protocol. During the trial the following shall be regularly verified: the informed consent and screening/registration status of study participants; the correctness of all data records and their consistency with the original documents; all errors or omissions have been corrected or noted signed and dated by the investigator; special circumstances related to the study participants during the research shall be confirmed and recorded; all adverse events are documented and serious adverse events are reported recorded and handled in a timely manner within the specified time etc.

数据管理委员会：

Data Managemen Committee：

无

No

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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