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Study on the clinical efficacy of Qi Huang Li Yan San in the treatment of qi stagnation and blood stasis type lateral collateral ligament injury of ankle joints

注册号：

Registration number：

ITMCTR2025000647

最近更新日期：

Date of Last Refreshed on：

2025-04-06

注册时间：

Date of Registration：

2025-04-06

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

七黄理伤散治疗气滞血瘀型踝关节外侧副韧带损伤的临床疗效研究

Public title：

Study on the clinical efficacy of Qi Huang Li Yan San in the treatment of qi stagnation and blood stasis type lateral collateral ligament injury of ankle joints

注册题目简写：

English Acronym：

研究课题的正式科学名称：

七黄理伤散治疗气滞血瘀型踝关节外侧副韧带损伤的临床疗效研究

Scientific title：

Study on the clinical efficacy of Qi Huang Li Yan San in the treatment of qi stagnation and blood stasis type lateral collateral ligament injury of ankle joints

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：

王达

研究负责人：

王尚全

Applicant：

WangDa

Study leader：

WangShangquan

申请注册联系人电话：

Applicant telephone：

15707491898

研究负责人电话：

Study leader's telephone：

13901147122

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：

242804490@qq.com

研究负责人电子邮件：

Study leader's E-mail：

13901147122@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：

北京市朝阳区望京中环南路6号中国中医科学院望京医院

研究负责人通讯地址：

北京市朝阳区望京中环南路6号中国中医科学院望京医院

Applicant address：

Wangjing Hospital China Academy of Traditional Chinese Medicine No. 6 Wangjing Zhonghuan South Road Chaoyang District Beijing China

Study leader's address：

Wangjing Hospital China Academy of Traditional Chinese Medicine No. 6 Wangjing Zhonghuan South Road Chaoyang District Beijing China

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：

中国中医科学院望京医院运动医学二科

Applicant's institution：

Department of Sports Medicine II Wangjing Hospital China Academy of Traditional Chinese Medicine China

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：

WJEC-KT-2024-083-P002

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：

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee Wangjing Hospital China Academy of Traditional Chinese Medicine China

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/13 0:00:00

伦理委员会联系人：

王浩

Contact Name of the ethic committee：

WangHao

伦理委员会联系地址：

中国中医科学院望京医院行政楼305室

Contact Address of the ethic committee：

Room 305 Administration Building Wangjing Hospital China Academy of Traditional Chinese Medicine China

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-84739681

伦理委员会联系人邮箱：

Contact email of the ethic committee：

wd926432@icloud.com

研究实施负责（组长）单位：

中国中医科学院望京医院

Primary sponsor：

Wangjing Hospital China Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市朝阳区望京中环南路6号中国中医科学院望京医院

Primary sponsor's address：

Wangjing Hospital China Academy of Traditional Chinese Medicine No. 6 Wangjing Zhonghuan South Road Chaoyang District Beijing 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)：

北京市

市(区县)：

朝阳区

Country：

China

Province：

Beijing

City：

Chaoyang district

单位(医院)：

中国中医科学院望京医院

具体地址：

北京市朝阳区望京中环南路6号

Institution
hospital：

Wangjing Hospital China Academy of Traditional Chinese Medicine

Address：

Wangjing Hospital China Academy of Traditional Chinese Medicine No. 6 Wangjing Zhonghuan South Road Chaoyang District Beijing China

经费或物资来源：

中国中医科学院望京医院高水平中医医院建设项目 “加强医疗机构中药制剂研发与新药转化” 专项课题

Source(s) of funding：

Special Project on "Strengthening the Research and Development of Chinese Medicinal Preparations and Transformation of New Drugs in Medical Institutions" of the High-level Chinese Medicine Hospital Construction Project of Wangjing Hospital China Academy of Traditional Chinese Medicine (CATCM)

研究疾病：

气滞血瘀型踝关节外侧副韧带损伤

研究疾病代码：

Target disease：

Lateral collateral ligament of the ankle injury

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

单臂

Single arm

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

运用七黄理伤散治疗气滞血瘀型踝关节外侧副韧带损伤的临床疗效研究，观察七黄理伤散在缓解气滞血瘀型踝关节外侧副韧带损伤患者踝关节疼痛、肿胀及功能障碍等方面的改善情况，证实其有效性和安全性。

Objectives of Study：

The clinical efficacy of Qi Huang Li Yan San in the treatment of qi stagnation and blood stasis type lateral collateral ligament injury of ankle joint was studied to observe the improvement of Qi Huang Li Yan San in relieving ankle joint pain swelling and dysfunction of patients with qi stagnation and blood stasis type lateral collateral ligament injury of ankle joint and to confirm its efficacy and safety.

药物成份或治疗方案详述：

基础治疗： ①制动，减少关节负荷，限制活动，减少组织出血，防止伤势扩大并降低恶化伤势。 ②将受伤部位抬高超于心脏，促进组织液回流，减轻肿胀反应。 ③帮助患者了解急性踝关节损伤后治疗内容及注意事项，对损伤功能的恢复进程有正确的认知。保持良好的心态，积极面对疾病发生发展。 ④在疼痛与肿胀获得控制后，循序渐进承受负重，刺激组织修复，重塑肌肉、肌腱和韧带的功能。可先在无痛的范围内适当的进行运动训练，促进关节功能恢复，强化关节的稳定性。 干预治疗： ①采用七黄理伤散和基础治疗的治疗方式。 ②用法用量： 全部纳入患者予七黄理伤散，药物组成：生大黄15g、三七粉9g、醋乳香5g、醋没药5g、醋延胡索10g、生大蓟15g、人工冰片0.3g、芒硝15g，8味中药共74.3g，中药外敷15 min/次，2次/d，连续治疗1周；药物制作方法：将自制方剂七黄理伤散研成细末状，加酒，调匀成糊状，取适量于无菌敷料上，涂敷于患踝。

Description for medicine or protocol of treatment in detail：

Basic treatment: ① Brake to reduce joint loading limit activity reduce tissue bleeding prevent enlargement and reduce worsening injury. ② Elevate the injured part over the heart to promote tissue fluid return and reduce the swelling response. ③ Help patients to understand the contents of treatment and precautions after acute ankle injury and have a correct knowledge of the recovery process of injury function. Maintain a good state of mind and positively face the disease occurrence and development. ④ After pain and swelling are under control bear weight gradually to stimulate tissue repair and remodel the function of muscles tendons and ligaments. Appropriate exercise training can be carried out in a pain-free range first to promote the recovery of joint function and strengthen the stability of joints. Intervention treatment: ① Adopt the treatment modality of Qi Huang Li Yan San and basic treatment. ② Dosage: All the included patients were given Qihuang Liribian San drug composition: raw rhubarb 15g Panax ginseng powder 9g vinegar frankincense 5g vinegar myrrh 5g vinegar Yanhuisuo 10g raw artichoke 15g artificial ice 0.3g manganese nitrate 15g a total of 74.3g of 8 flavours of traditional Chinese medicine traditional Chinese medicine external application 15 min/time 2 times/d continuous treatment for 1 week; drug production method: the homemade formula Qihuang Liribian San is crushed into fine powder add wine mix it into a paste. Add wine mix well into paste take appropriate amount on sterile dressing apply to the affected ankle.

纳入标准：

①符合西医诊断标准，分级标准符合一级及二级韧带损伤，符合中医辨证气滞血瘀型诊断标准； ②年龄在18-55周岁之间，性别不限；初次踝关节损伤，病程1-14天； ③沟通顺畅，能够听从医生进行各项治疗、检查和评分； ④在过去6个月里未接受过踝关节侵袭性检查，没有接受过踝关节手术，且非踝关节手术适应症患者； ⑤7天内患者不能经过其他同类型治疗，若已治疗，则必须间隔至少7天的洗脱期； ⑥患者对本项研究知情同意，自愿参加并签署相关知情同意书。

Inclusion criteria

① Meet the diagnostic criteria of western medicine grading criteria meet the first and second grade ligament injuries and meet the diagnostic criteria of Chinese medicine identification of qi stagnation and blood stasis type; ② Age between 18-55 years old gender is not limited; first-time ankle injury disease duration 1-14 days; ③ Smooth communication and able to listen to the doctor for all treatments examinations and scoring; ④ Patients who have not undergone invasive ankle examination in the past 6 months have not undergone ankle surgery and are not indications for ankle surgery; ⑤ Patients must not have undergone any other treatment of the same type within 7 days and if they have been treated they must have been separated by a washout period of at least 7 days; ⑥Patients give informed consent to this study participate voluntarily and sign the relevant informed consent form.

排除标准：

①合并有踝关节或足部骨折、脱位，或肌腱、韧带断裂者； ②既往有慢性踝关节不稳，反复扭伤病史 ③患者体质易过敏，对于试验药物过敏的患者，孕产妇及哺乳期女性患者； ④踝关节局部有皮肤软组织破损或皮肤病患者； ⑤合并有严重的心、脑、肝、肾、造血系统等疾病； ⑥存在精神疾患，不能配合医生治疗的患者者； ⑦根据研究员判断，患者入组可能性低或入组后因其他各种原因影响，极易造成失访者。

Exclusion criteria：

① Combined with ankle or foot fracture dislocation or tendon or ligament rupture; ② chronic ankle instability repeated sprain history ③Patients with allergy allergy to test drugs pregnant and lactating female patients; ④Patients with local skin and soft tissue damage or dermatological diseases of the ankle joint; ⑤ Combined with serious heart brain liver kidney haematopoietic system and other diseases; ⑥ Patients with mental disorders who are unable to cooperate with the doctor's treatment; ⑦ Patients who according to the researcher's judgement have a low probability of being enrolled in the group or who are highly susceptible to loss of visits due to the influence of various other reasons after enrolment.

研究实施时间：

Study execute time：

从From 2024-12-13

至To      2025-12-01

征募观察对象时间：

Recruiting time：

从From 2025-04-07

至To      2025-10-31

干预措施：

Interventions：

组别：

试验组

样本量：

30

Group：

test group

Sample size：

干预措施：

七黄理伤散和基础治疗

干预措施代码：

Intervention：

Qi Huang Li Yan San and Basic Treatment

Intervention code：

样本总量 Total sample size ： 30

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

朝阳区

Country：

China

Province：

BeiJing

City：

Chaoyang district

单位(医院)：

中国中医科学院望京医院

单位级别：

三级甲等中医医院

Institution/hospital：

Wangjing Hospital China Academy of Traditional Chinese Medicine

Level of the institution：

Grade 3A Chinese Medicine Hospital

测量指标：

Outcomes：

指标中文名：

肌骨超声下外踝韧带厚度、长度

指标类型：

次要指标

Outcome：

Thickness and length of the external ankle ligament by musculoskeletal ultrasound

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

踝关节周长

指标类型：

次要指标

Outcome：

ankle joint circumference

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟疼痛评分法

指标类型：

主要指标

Outcome：

visual analogue scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

足与踝功能测量表

指标类型：

次要指标

Outcome：

Foot and Ankle Ability Measure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

踝关节活动度

指标类型：

次要指标

Outcome：

ankle mobility

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

美国骨科足踝外科协会踝与后足评分

指标类型：

次要指标

Outcome：

the American Association of Foot and Ankle Surgery

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 55 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）：

不采用随机方法

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

No randomised approach

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）：

依托医院完成共享

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

Relying on hospitals to complete sharing

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：

本课题病历记录表将由课题负责人与医院相关科室工作人员合作填写；数据经质量控制小组确认无误后上传至网络数据登记平台记录，并在公开研究结束后经医院公开

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

The medical record form of this subject will be filled in by the person in charge of the subject and the staff of relevant departments in the hospital. After the data is confirmed by the quality control team it is uploaded to the network data registration platform for record and disclosed by the hospital after the public study is completed

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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