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Study on the efficacy of external treatment with traditional Chinese medicine for postoperative lymphatic edema

注册号：

Registration number：

ITMCTR2025000332

最近更新日期：

Date of Last Refreshed on：

2025-02-18

注册时间：

Date of Registration：

2025-02-18

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中药外治法对术后淋巴水肿的疗效研究

Public title：

Study on the efficacy of external treatment with traditional Chinese medicine for postoperative lymphatic edema

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中药外治法对术后淋巴水肿的疗效研究

Scientific title：

Study on the efficacy of external treatment with traditional Chinese medicine for postoperative lymphatic edema

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：

黄立师

研究负责人：

黄立师

Applicant：

huang lishi

Study leader：

huang lishi

申请注册联系人电话：

Applicant telephone：

17802163577

研究负责人电话：

Study leader's telephone：

17802163577

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：

414044832@qq.com

研究负责人电子邮件：

Study leader's E-mail：

414044832@qq.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：

上海市徐汇区衡山路910号

研究负责人通讯地址：

上海市徐汇区衡山路910号

Applicant address：

No. 910, Hengshan Road, Xuhui District, Shanghai

Study leader's address：

No. 910, Hengshan Road, Xuhui 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：

中国福利会国际和平妇幼保健院

Applicant's institution：

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

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：

GKLW-A-2024-108-01

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：

国际和平妇幼保健院医学科研伦理委员会

Name of the ethic committee：

The Medical Scientific Research Ethics Committee of International Peace Maternity and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/27 0:00:00

伦理委员会联系人：

张延菲

Contact Name of the ethic committee：

zhang yanfei

伦理委员会联系地址：

上海市徐汇区衡山路910号

Contact Address of the ethic committee：

No. 910, Hengshan Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

50407

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gfykyll@163.com

研究实施负责（组长）单位：

中国福利会国际和平妇幼保健院

Primary sponsor：

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

研究实施负责（组长）单位地址：

上海市徐汇区衡山路910号

Primary sponsor's address：

No. 910, Hengshan Road, Xuhui 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

市(区县)：

Country：

CHINA

Province：

shanghai

City：

单位(医院)：

中国福利会国际和平妇幼保健

具体地址：

上海市徐汇区衡山路910号

Institution
hospital：

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

Address：

No. 910, Hengshan Road, Xuhui District, Shanghai

经费或物资来源：

上海市卫生健康委员会

Source(s) of funding：

Shanghai Municipal Health Commission

研究疾病：

子宫内膜恶性肿瘤

研究疾病代码：

Target disease：

malignant tumor of the endometrium

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：

本研究探索中西医结合在子宫内膜恶性肿瘤预防、早期诊断、治疗、术后康复的优势与互补作用。通过中西医结合的方式，利用中医的整体观念和西医的先进检测手段，有助于提高子宫内膜恶性肿瘤的早期诊断率，减少晚期确诊病例的发生，从而提高患者的生存率。中西医结合治疗不仅拓展了西医单一治疗的局限，减轻患者术后或治疗过程中可能出现的副作用，帮助患者在术后加速康复，恢复身体机能，预防复发与转移，延长生存时间，同时改善其生活质量，使患者在治疗与康复过程中受益。 本项目将为中西医结合治疗子宫内膜恶性肿瘤提供科学依据，推动中西医临床协作的进步与发展，拓宽两者在恶性肿瘤治疗中的应用前景，推动中西医融合模式的创新。

Objectives of Study：

This study explores the advantages and complementary roles of integrated traditional Chinese and Western medicine (TCM-WM) in the prevention early diagnosis treatment and postoperative rehabilitation of endometrial malignant tumors. By combining TCM and WM leveraging the holistic concept of TCM and the advanced diagnostic tools of WM we aim to improve the early diagnosis rate of endometrial malignant tumors reduce the occurrence of late-stage diagnoses and consequently enhance patients' survival rates. The integrated treatment not only transcends the limitations of monotherapy with WM by alleviating potential side effects that patients may experience post-surgery or during treatment but also accelerates patients' postoperative recovery restores bodily functions prevents recurrence and metastasis and extends survival time. Additionally it improves patients' quality of life benefiting them throughout the treatment and rehabilitation process. This project will provide a scientific basis for the integrated treatment of endometrial malignant tumors with TCM-WM promote the progress and development of clinical collaboration between TCM and WM broaden their application prospects in the treatment of malignant tumors and drive innovation in the integrated TCM-WM model.

药物成份或治疗方案详述：

2、治疗方案：试验组：外用温经消肿方熏蒸＋功能锻炼；对照组：功能锻炼；研究过程共28天，在入组前、入组第7天、第14天、第21天、第28天进行5次随访。 2.1药物使用方法：预先将每贴中药物浓煎成20ml，放置温度合适后装入我院自主研发的外用熏洗装置防止肿胀部位进行熏蒸，每次每部位时长为30min，每日1次。 2.2外用温经消肿方：药物组成包括：独活15g，乳香10g，细辛10g，川芎10g，黄芪20g，红花6g，苏木15g，艾叶10g ,煎煮后使用我院自主研发的外用熏洗装置进行熏蒸。功能锻炼：进行下肢伸拉、原地踏步、爬楼梯等髋关节及膝关节运动，以恢复下肢基本的伸展功能，每次锻炼10分钟，每天3次。

Description for medicine or protocol of treatment in detail：

Treatment Protocol: Experimental Group: External application of Warming Meridian and Reducing Swelling Decoction for fumigation + Functional Exercise; Control Group: Functional Exercise; The study duration is 28 days with five follow-ups conducted before enrollment and on the 7th 14th 21st and 28th days after enrollment. 2.1 Method of Drug Administration: Each herbal patch is pre-boiled down to 20ml of concentrated medicine. After reaching a suitable temperature it is placed in our hospital's self-developed external fumigation device for fumigating the swollen area. Each session lasts 30 minutes per area once daily. 2.2 External Application of Warming Meridian and Reducing Swelling Decoction: The herbal formula consists of: 15g of Angelica Pubescens 10g of Frankincense 10g of Asarum 10g of Chuanxiong 20g of Astragalus 6g of Safflower 15g of Sappanwood and 10g of Mugwort Leaf. After decoction the concentrated medicine is used for fumigation with our hospital's self-developed external fumigation device. Functional Exercise: Lower limb stretching stepping in place stair climbing and other hip and knee joint exercises are performed to restore basic extension function of the lower limbs. Each exercise session lasts 10 minutes three times a day.

纳入标准：

纳入标准：①明确诊断为妇科恶性肿瘤术后下肢淋巴水肿；②年龄在30-75岁之间；③疾病分期符合淋巴水肿分期为I期或II期患者；④中医辨证为阳虚水泛型；⑤对本研究具体内容与方法了解同意，并且自愿加入本次研究。

Inclusion criteria

①Postoperative lower limb lymphatic edema secondary to gynecological malignant tumors; ②Aged between 30 and 75 years; ③Disease stage corresponds to lymphatic edema Stage I or II; ④Diagnosed as Yang deficiency with water accumulation syndrome according to traditional Chinese medicine syndrome differentiation; ⑤After being fully informed of the specific content and methods of this study the patient understands and agrees to participate and voluntarily joins this study.

排除标准：

排除标准：①复查后有肿瘤转移、淋巴结转移者；②伴心、肺、肝、肾或甲状腺功能减退、低蛋白血症等严重的原发疾病或精神障碍等疾病者；③患侧肢体部分皮肤存在皮疹、外伤、溃疡、感染者；④有慢性皮肤病病史，对中药易过敏的患者；⑤正在接受化疗、放疗或足疗程化疗、放疗结束后不满3个月的患者；⑥患肢有动静脉血栓、动静脉硬化等下肢血管疾病者。

Exclusion criteria：

Exclusion Criteria: ① Patients with tumor metastasis or lymphatic metastasis after re-examination; ② Patients with severe primary diseases such as heart lung liver kidney or thyroid dysfunction hypoproteinemia or mental disorders; ③ Patients with skin rashes trauma ulcers or infections on the affected limb; ④ Patients with a history of chronic skin diseases or who are prone to allergies to traditional Chinese medicine; ⑤ Patients who are currently undergoing chemotherapy radiotherapy or have completed a full course of chemotherapy or radiotherapy within the last 3 months; ⑥ Patients with lower limb vascular diseases such as arterial and venous thrombosis or arteriosclerosis in the affected limb.

研究实施时间：

Study execute time：

从From 2024-11-01

至To      2027-10-31

征募观察对象时间：

Recruiting time：

从From 2025-03-01

至To      2027-05-01

干预措施：

Interventions：

组别：

治疗组

样本量：

30

Group：

Treatment group

Sample size：

干预措施：

熏蒸

干预措施代码：

Intervention：

steaming

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

锻炼

干预措施代码：

Intervention：

Exercise

Intervention code：

样本总量 Total sample size ： 60

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：

shahnghai

City：

单位(医院)：

中国福利会国际和平妇幼保健

单位级别：

三甲

Institution/hospital：

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine Shanghai

Level of the institution：

Grade A tertiary hospita

测量指标：

Outcomes：

指标中文名：

妇科恶性肿瘤淋巴水肿问卷

指标类型：

次要指标

Outcome：

Questionnaire on Lymphatic Edema following Gynecological Malignancies

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

下肢周径

指标类型：

主要指标

Outcome：

circumference of the lower limbs

Type：

Primary indicator

测量时间点：

入组前、入组第7天、第14天、第21天、第28天

测量方法：

共设5个测量点位，测量治疗前后患侧肢体的周径，取患者脚背、踝上5cm、膝下10cm、膝上10cm、膝上20cm处进行测量

Measure time point of outcome：

Before enrollment and on the 7th 14th 21st and 28th days after enrollment.

Measure method：

A total of 5 measurement points are set to measure the circumference of the affected limb before and after treatment. The measurements are taken at the following locations: the dorsum of the foot 5 cm above the ankle 10 cm below the knee 10 cm above the knee and 20 cm above the knee.

指标中文名：

一般情况

指标类型：

次要指标

Outcome：

general condition

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应

指标类型：

次要指标

Outcome：

adverse reaction

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：

无

组织：

Sample Name：

NO

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 30 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

统计师采用SPSS软件利用随机区组分层随机的方法产生随机序列” "由第三方统计人员运用SPSS统计软件，采用随机数字表法生成随机方案"

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

The statistician generates a random sequence using the method of stratified random sampling of random blocks in SPSS software. "A third-party statistician uses SPSS statistical software to generate a random plan using the random number table method."

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)：

not share

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：

不共享

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

not share

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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