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Application research of applying Sihuang Powder to Yongquan acupoint in the prevention of DVT in Patients undergoing Hip and Knee Arthroplasty

注册号：

Registration number：

ITMCTR2025001514

最近更新日期：

Date of Last Refreshed on：

2025-07-30

注册时间：

Date of Registration：

2025-07-30

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

四黄粉贴敷涌泉穴在髋膝关节置换术患者DVT预防中的应用研究

Public title：

Application research of applying Sihuang Powder to Yongquan acupoint in the prevention of DVT in Patients undergoing Hip and Knee Arthroplasty

注册题目简写：

English Acronym：

研究课题的正式科学名称：

四黄粉贴敷涌泉穴在髋膝关节置换术患者DVT预防中的应用研究

Scientific title：

Application research of applying Sihuang Powder to Yongquan acupoint in the prevention of DVT in Patients undergoing Hip and Knee Arthroplasty

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：

钱美玉

研究负责人：

钱美玉

Applicant：

Qian Meiyu

Study leader：

Qian Meiyu

申请注册联系人电话：

Applicant telephone：

15857988534

研究负责人电话：

Study leader's telephone：

15857988534

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：

793773639@qq.com

研究负责人电子邮件：

Study leader's E-mail：

793773639@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：

浙江省金华市婺城区双溪西路439号

研究负责人通讯地址：

浙江省金华市婺城区双溪西路439号

Applicant address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province

Study leader's address：

No. 439, Shuangxi West Road, Wucheng District, Jinhua City, Zhejiang Province

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：

浙江中医药大学附属金华中医院

Applicant's institution：

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese 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：

金华市中医医院轮审2025研第015号-批

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：

金华市中医医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Jinhua Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/27 0:00:00

伦理委员会联系人：

冷燕奎

Contact Name of the ethic committee：

Leng Yankui

伦理委员会联系地址：

浙江省金华市婺城区双溪西路439号

Contact Address of the ethic committee：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

0579-82136688

伦理委员会联系人邮箱：

Contact email of the ethic committee：

809405733@qq.com

研究实施负责（组长）单位：

浙江中医药大学附属金华中医院

Primary sponsor：

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

研究实施负责（组长）单位地址：

浙江省金华市婺城区双溪西路439号

Primary sponsor's address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

金华市婺城区

Country：

China

Province：

Zhejiang Province

City：

Wucheng District Jinhua City

单位(医院)：

浙江中医药大学附属金华中医院

具体地址：

浙江省金华市婺城区双溪西路439号

Institution
hospital：

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

Address：

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

经费或物资来源：

浙江中医药大学

Source(s) of funding：

Zhejiang Chinese Medical University

研究疾病：

常见病、多发病的适宜中医护理技术培育研究

研究疾病代码：

Target disease：

Research on the Cultivation of Appropriate Traditional Chinese Medicine Nursing Techniques for Common and Frequently-occurring Diseases

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：

（1）通过探索四黄粉贴敷涌泉穴，明确其有降低髋膝关节置换术患者DVT的发生率及改善临床肿胀、疼痛症状。 （2）通过四黄粉贴敷涌泉穴，证实其预防髋膝关节置换术患者DVT的有效性及安全性，进而减少DVT的发生率。

Objectives of Study：

(1) By exploring the application of Sihuang powder on the Yongquan acupoint, it was clarified that it can reduce the incidence of DVT in patients undergoing hip and knee arthroplasty and improve clinical swelling and pain symptoms. (2) By applying Sihuang powder to Yongquan acupoint, the efficacy and safety of preventing DVT in patients undergoing hip and knee arthroplasty were confirmed, thereby reducing the incidence of DVT.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

年龄≥65岁；有明确手术指征，且行首次全髋、全膝关节置换术患者；Caprini评分≥5分；对抗凝药物或对外敷药物既往没有禁忌者；听力、视力良好，有正常阅读、沟通、交流理解能力；患者经培训能使用微信等工具接受健康教育者；告知研究事项后，患者或家属均签署知情同意书。

Inclusion criteria

Age ≥65 years old; Patients with clear surgical indications and undergoing the first total hip and total knee arthroplasty; The Caprini score is ≥5 points; Those who have no contraindications to anticoagulant drugs or topical medications in the past; Good hearing and vision, with normal reading, communication and exchange comprehension abilities; Patients can receive health education by using tools such as wechat after training. After being informed of the research matters, both the patients and their families signed the informed consent form.

排除标准：

合并其他病理性骨折；患肢既往已瘫痪或其他原因导致运动功能障碍；存在严重基础性疾病、精神疾病、认知功能障碍、恶性肿瘤等；有其他下肢血管疾病史者；有急性肺动脉栓塞、急性小腿损伤性血肿、小腿肌纤维组织炎等疾病者；抗凝药物或对外敷药物过敏者。

Exclusion criteria：

Combined with other pathological fractures; The affected limb has been paralyzed previously or has motor dysfunction due to other reasons; There are serious underlying diseases, mental disorders, cognitive dysfunction, malignant tumors, etc. Those with a history of other lower extremity vascular diseases; Those with diseases such as acute pulmonary embolism, acute traumatic hematoma of the lower leg, and fibrostitis of the lower leg muscle; Those who are allergic to anticoagulant drugs or topical medications.

研究实施时间：

Study execute time：

从From 2025-08-01

至To      2027-12-31

征募观察对象时间：

Recruiting time：

从From 2025-08-01

至To      2027-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

33

Group：

experimental group

Sample size：

干预措施：

试验组在对照组基础上采用四黄粉贴敷涌泉穴。

干预措施代码：

Intervention：

The experimental group applied Four yellow powder patches to the Yongquan acupoint on the basis of the control group.

Intervention code：

组别：

对照组

样本量：

33

Group：

control group

Sample size：

干预措施：

予常规综合护理干预：包括常规入院宣教、基本预防、物理预防及药物预防。a患者入院后进行常规入院宣教，口头、书面、微信公众号视频播放告知病人及家属深静脉血栓的危险性、后果、预防方法；b开展基本预防，嘱患者多饮水，低脂清淡饮食，肢体抬高15-30°，下肢主动、被动肌肉收缩活锻炼；c协助患者进行部分或全部负重活动，包括床旁原地行走、从床头到床旁椅等病室内活动。

干预措施代码：

Intervention：

carried out basic prevention instructing the patient to drink plenty of water have a low-fat and light diet elevate the limbs by 15-30 degrees and perform active and passive muscle contraction exercises for the lower limbs. c assists patients in performing partial or full weight-bearing activities including walking in place beside the bed and moving from the bedside to the bedside chair and other activities within the ward.

Intervention code：

样本总量 Total sample size ： 66

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

金华市婺城区

Country：

China

Province：

Zhejiang Province

City：

Wucheng District, Jinhua City

单位(医院)：

金华市中医医院

单位级别：

三级甲等综合性医院

Institution/hospital：

Jinhua Hospital of Traditional Chinese Medicine

Level of the institution：

Grade-a tertiary general hospital

测量指标：

Outcomes：

指标中文名：

凝血功能指标

指标类型：

主要指标

Outcome：

Coagulation function indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

下肢深静脉血栓发生率

指标类型：

主要指标

Outcome：

The incidence of deep vein thrombosis in the lower extremities

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 65 岁
Min age years
最大 100 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）：

用Excel生成随机数。拟定随机化方案，随机化分配方法由不参加临床研究的人员产生，并制成随机分配卡片，加信封密封。合格病例进入试验时，按其进入的先后次序，拆开信封，按信封内卡片规定的分组进行治疗。随机数字表按要求进行保存随机分为试验组(四黄粉贴敷涌泉穴组)和对照组(常规综合护理组)。

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

Generate random numbers using Excel. A randomization protocol was formulated. The randomization allocation method was generated by personnel who did not participate in the clinical study, and a randomization allocation card was made and sealed in an envelope. When qualified cases enter the trial, in the order of their entry, the envelopes are opened and they are treated according to the groups specified on the cards inside the envelopes. The random number table was saved as required and randomly divided into the experimental group (Yongquan acupoint group with Four yellow powder application) and the control group (conventional comprehensive nursing group).

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）：

ResMan临床试验公共管理平台http://www.medresman.org.cn/uc/index.aspx

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

ResMan Clinical Trial Public Management Platform http://www.medresman.org.cn/uc/index.aspx

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：

1.筛选符合纳入标准的受试者填写此表。 2.病例报告表填写需准确、清晰，不可任意涂改，错误之处需纠正时要用横线居中划出，并标注修改者姓名及修改时间。 3.填写记录笔皆用钢笔、碳素签字笔。 4.患者姓名缩写一栏需四个小格均填满，如果姓名为两字需记录拼音前两字母；若姓名为三字，需记录三字首字母并后缀第三字的第二字母；若姓名为四个字，则记录每字首字母。举例：张林ZHLI，王红军WHJU，欧阳光明OYGM，王娥WAEE。 5.所有表格日期均为“年/月/日”，如果不知道具体日期，请用“UK”替代以“年/月/UK”的形式填入日期，请尽可能填写完整。 6.表格中所有项目均按要求，不得留空。 7.所有检验项目未做或遗漏，需填ND；具体合并用药剂量与时间不详，请填写NK。 8.试验期间应认真填写四黄粉贴敷使用情况、不良事件。记录不良事件所发生的时间、严重相关程度、持续的时间、所采取的措施和转归。如有严重的不良事件出现，应包括临床试验过程中所发生需要住院治疗、延长受试者住院时间、伤残、影响工作生活质量及危及生命，必须即刻通知主要研究单位伦理委员会及申办单位。

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

1. Select the subjects who meet the inclusion criteria and fill out this form. 2. The case report form should be filled out accurately and clearly. No arbitrary alterations are allowed. When errors need to be corrected, they should be marked with a horizontal line centered, along with the name of the person making the correction and the correction time. 3. All records should be filled in with fountain pens or carbon signature pens. 4. The column for the abbreviation of the patient's name should be filled in all four small squares. If the name consists of two characters, the first two letters of the pinyin should be recorded. If the name consists of three characters, the first letter of each character should be recorded along with the second letter of the third character. If the name consists of four characters, record the first letter of each character. For example: Zhang Lin ZHLI, Wang Hongjun WHJU, Ouyang Guangming OYGM, Wang E WAEE. 5. All the dates in the forms should be "year/month/day". If you don't know the specific date, please use "UK" instead and fill in the date in the form of "year/month /UK". Please fill in as completely as possible. All items in the table must be in accordance with the requirements and no blanks should be left. 7. All inspection items have not been conducted or have been omitted. Please fill in "ND". The specific dosage and time of combined medication are unknown. Please fill in NK. During the trial period, the application status and adverse events of the Four Yellow powder should be filled in carefully. Record the time of occurrence, severity correlation, duration, measures taken and outcome of adverse events. In the event of serious adverse events, including those that occur during the clinical trial and require hospitalization, prolong the hospitalization time of the subjects, cause disability, affect the quality of work and life, and endanger life, the ethics committee of the main research unit and the sponsor unit must be notified immediately.

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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