ChiCTR2200056802 版本V1.0 版本创建时间2022/02/17 21:40:14 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2200056802 

最近更新日期：

Date of Last Refreshed on：

2022-02-17 21:39:59 

注册时间：

Date of Registration：

2022-02-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

急性韧带损伤中医证候规律与规范化中药外治临床研究

Public title：

Pattern Identification and Standardized External Herbal Treatment of Acute Ligament Injury: a Clinical Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

急性韧带损伤中医证候规律与规范化中药外治临床研究

Scientific title：

Pattern Identification and Standardized External Herbal Treatment of Acute Ligament Injury: a Clinical Study

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：

李妍 

研究负责人：

张磊 

Applicant：

Yan Li 

Study leader：

Lei Zhang 

申请注册联系人电话：

Applicant telephone：

15117909057

研究负责人电话：

Study leader's telephone：

13911210120

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：

liyanxxxholic@163.com

研究负责人电子邮件：

Study leader's E-mail：

arthroartist@163.com

申请单位网址(自愿提供)：

Applicant 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：

北京市朝阳区花家地街6号中国中医科学院望京医院

研究负责人通讯地址：

北京市朝阳区花家地街6号中国中医科学院望京医院

Applicant address：

Wangjing hospital of Chinese Academy of traditional chinese medicine, No.6 Huajiadi Street, Chaoyang District, Beijing

Study leader's address：

Wangjing hospital of Chinese Academy of traditional chinese medicine, No.6 Huajiadi Street, Chaoyang District, Beijing

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

Applicant's institution：

Wangjing hospital of Chinese Academy of traditional chinese medicine

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

WJEC-KT-2021-041-P003

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件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 of Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2021-09-23 00:00:00

伦理委员会联系人：

王浩

Contact Name of the ethic committee：

Hao Wang

伦理委员会联系地址：

北京市朝阳区花家地街6号中国中医科学院望京医院

Contact Address of the ethic committee：

Wangjing hospital of Chinese Academy of traditional chinese medicine, No.6 Huajiadi Street, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

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 of Chinese Academy of traditional chinese medicine

研究实施负责（组长）单位地址：

北京市朝阳区花家地街6号中国中医科学院望京医院

Primary sponsor's address：

Wangjing hospital of Chinese Academy of traditional chinese medicine, No.6 Huajiadi Street, Chaoyang District, Beijing

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(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院望京医院

具体地址：

朝阳区花家地街6号

Institution
hospital：

Wangjing Hospital, China Academy of Chinese Medical Sciences

Address：

6 Huajiadi Street, Chaoyang District

经费或物资来源：

院拨经费

Source(s) of funding：

Hospital appropriation

Target disease：

Acute Ligament Injury

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

课题组近年来在加强中医骨伤原创理论创新及中医药的现代传承研究方针的指导下，针对中药外用治疗急、慢性韧带损伤，减轻关节外科术后肢体肿胀等开展大量工作，积累了丰富的临床经验。我们根据中医骨伤科三期辨证理论和急性筋伤组织损伤修复过程特点提出新的筋伤三期治法理念，即“凉血止血、活血化瘀、和营生新”。本课题以骨伤科门诊发病率最高的急性踝关节扭伤作为研究对象，通过标准随机对照临床试验提供高等级的临床证据，总结急性韧带损伤不同阶段中医证候规律，建立精准三期中药外洗方案，并验证其临床效果，实现中药复方精准用药关键技术突破，规范临床治疗。  

Objectives of Study：

In recent years, under the guidance of strengthening the original theoretical innovation of traditional Chinese medicine bone injury and the research policy of modern inheritance of traditional Chinese medicine, the research group has done a great deal of work to treat acute and chronic ligament injuries by external use of traditional Chinese medicine and reduce limb swelling after joint surgery, and accumulated rich clinical experience. According to the theory of three-stage syndrome differentiation in orthopedics and traumatology of traditional Chinese medicine and the characteristics of the repair process of acute tendon injury, we put forward a new concept of three-stage treatment of tendon injury, namely, "cooling blood to stop bleeding, promoting blood circulation to remove blood stasis, and making new living". In this study, acute ankle sprain, which has the highest incidence rate in outpatient department of orthopedics and traumatology, is taken as the research object. Through standard randomized controlled clinical trials, high-grade clinical evidence is provided, TCM syndrome patterns in different stages of acute ligament injury are summarized, and an accurate three-stage external washing scheme of Chinese medicine is established, and its clinical effect is verified, so as to achieve a breakthrough in key technologies of accurate medication of Chinese medicine compound and standardize clinical treatment.

药物成份或治疗方案详述：

纳入对照组中的患者将接受常规的急性踝关节外侧韧带复合体损伤（初次）保守治疗， 即：急性期 1 周内均予以局部冰敷和 6 周内统一品牌的支具固定保护治疗，伤后 3 周内患肢免负重。纳入观察组的患者在接受常规的保守治疗（同对照组）之外，还需额外进行中药 外用治疗，即：伤后 6 周内予以中药足浴，每日 2 次，每次 30 分钟。韧带损伤时间不同施与不同方药：前期（第 1 周）以凉血止血为主，方用走马散加减，足浴水温控制在 35℃-37℃左右；方药如下：侧柏叶 9g 三七 9g 血竭 2g 黄柏 12g 大黄 15g 栀子 10g 冰片 0.9g 芒硝12g 乳香 5g 没药 5g。中期（第 2-3 周）辅以活血化瘀，方用筋骨通络方加减，足浴水温控制在 38℃-40℃；方药如下：伸筋草 12g 透骨草 12g 川椒 6g 威灵仙 10g 刘寄奴 9g 海桐皮 12g 川芎 10g。后期（第 4-6 周）治以和营生新，方用接骨散加减，足浴水温控制在 38℃ -40℃。方药如下：骨碎补 9g 续断 10g 自然铜 10g 赤芍 15g 当归 12g 独活 10g 牛膝12g。 

Description for medicine or protocol of treatment in detail：

Patients in the control group will receive conventional (initial) conservative treatment for acute lateral ligament complex injury of ankle joint, that is, local ice compress within 1 week in acute stage and fixed protection treatment with braces of the same brand within 6 weeks, and the affected limb will be free of load within 3 weeks after injury. Patients in the observation group received conventional conservative treatment (the same as those in the control group), but also needed additional traditional Chinese medicine. External treatment, that is, foot bath with traditional Chinese medicine is given within 6 weeks after injury, twice a day for 30 minutes each time. Different prescriptions were applied at different time of ligament injury: in the early stage (the first week), it was mainly to cool blood and stop bleeding, and the prescription was Zou Ma San, and the water temperature of foot bath was controlled at about 35℃-37℃; The prescription is as follows: Platycladus orientalis 9g Sanqi 9g Dragon's Blood 2g Phellodendron 12g rhubarb 15g gardenia 10g borneol 0.9g mirabilite 12g frankincense 5g myrrh 5g. In the middle stage (the 2nd-3rd week), with the help of promoting blood circulation and removing blood stasis, the prescription of strengthening bones and removing collaterals was used, and the water temperature of foot bath was controlled at 38℃-40℃. The prescription is as follows: Lycopodium distichum 12g, Sichuan pepper 6g, Clematis chinensis 10g, Liu Anonu 9g, Pittosporum bark 12g, Chuanxiong 10g. In the later stage (4th-6th week), Jiegu powder was used to treat the disease with harmony, and the water temperature of foot bath was controlled at 38℃ -40℃. The prescription is as follows: Rhizoma Drynariae 9g Dipsacus 10g Pyritum 10g Radix Paeoniae Rubra 15g Angelica 12g Radix Angelicae Pubescentis 10g Achyranthis Radix 12g. 

纳入标准：

（1）符合诊断标准；（2）18 周岁≤年龄≤50 周岁；（3）言语流利，神志清晰，可准确评价及描述自身不适症状；（4）签署知情同意书。

Inclusion criteria

(1) meet the diagnostic criteria; (2)18 years old ≤50 years old; (3) Fluent in speech, clear in mind, and able to accurately evaluate and describe symptoms of self-discomfort; (4) Sign the informed consent form.

排除标准：

（1）合并骨折、撕脱骨折或软骨损伤；（2）功能性踝关节不稳；（3）X 线片提示踝关节退变 Kellgren-Lawrence（K-L）分级＞Ⅱ级；（4）瘢痕体质、过敏体质或存在既往外用中药过敏史；（5）既往肿瘤病史或关节特异及非特异性滑膜炎症患者；（6）BMI 体重指数超过正常范围 20%；（7）Beighton 评分≥4 分；（8）同期因其他疾病接受药物治疗的患者；（9）患有严重的心脑血管疾病、皮肤病及用药局部有破损的患者；（10）体内含有金属或内植物（材质无法确定或材质无法进行 MRI 检查）、幽闭恐惧症，导致无法顺利进
行 MRI 检查的患者。

Exclusion criteria：

(1) Combined fracture, avulsion fracture or cartilage injury; (2) Functional ankle instability; (3)X-ray film showed that Kellgren-Lawrence(K-L) grade of ankle degeneration was greater than Grade II; (4) Scar constitution, allergic constitution or past history of allergy to external traditional Chinese medicine; (5) Patients with previous tumor history or joint-specific and nonspecific synovitis; (6)BMI body mass index exceeds the normal range by 20%; (7)Beighton score ≥4 points; (8) Patients receiving medication for other diseases in the same period; (9) Patients suffering from severe cardiovascular and cerebrovascular diseases, skin diseases and local breakage of medication; (10) Patients with metal or endophytes in their bodies (the material cannot be determined or the material cannot be examined by MRI) and claustrophobia, which leads to the inability to perform MRI examination smoothly.

研究实施时间：

Study execute time：

从 From 2021-07-01 00:00:00至 To 2024-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-03-01 00:00:00 至 To 2023-08-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

180

Group：

Control group

Sample size：

干预措施：

常规保守治疗

干预措施代码：

Intervention：

Conventional conservative treatment

Intervention code：

组别：

观察组

样本量：

180

Group：

Observation group

Sample size：

干预措施：

中药外用治疗+常规保守治疗

干预措施代码：

Intervention：

Traditional Chinese medicine external treatment + conventional conservative treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国中医科学院望京医院 

单位级别：

三级甲等 

Institution
hospital：

Wangjing Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分

指标类型：

主要指标

Outcome：

Visual analogue scale

Type：

Primary indicator

测量时间点：

初次入组和第1周、第3周、第6周

测量方法：

Measure time point of outcome：

First enrollment and week 1, week 3, and week 6

Measure method：

指标中文名：

踝围

指标类型：

主要指标

Outcome：

Ankle circumference

Type：

Primary indicator

测量时间点：

初次入组和第1周、第3周、第6周

测量方法：

Measure time point of outcome：

First enrollment and week 1, week 3, and week 6

Measure method：

指标中文名：

美国足踝外科踝功能评分

指标类型：

主要指标

Outcome：

American foot and ankle surgery ankle function score

Type：

Primary indicator

测量时间点：

初次入组和第6周、第12周

测量方法：

Measure time point of outcome：

The first entry and the 6th and 12th week

Measure method：

指标中文名：

卡尔森踝关节功能评分系统

指标类型：

主要指标

Outcome：

Carlson ankle function scoring system

Type：

Primary indicator

测量时间点：

初次入组和第6周、第12周

测量方法：

Measure time point of outcome：

The first entry and the 6th and 12th week

Measure method：

指标中文名：

核磁共振信噪比

指标类型：

主要指标

Outcome：

Nuclear magnetic resonance signal-to-noise ratio

Type：

Primary indicator

测量时间点：

初次入组和第6周、第12周

测量方法：

Measure time point of outcome：

The first entry and the 6th and 12th week

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

Null

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验由课题组成员使用区组随机化分组，拟采用SAS 9.4软件给定种子数，产生360例受试者的随机编码表，按就诊顺序分别入组，同时对患者保密治疗分组信息。

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

In this experiment, the members of the research group were randomized into groups by block. It is planned to use SAS 9.4 software to give the number of seeds, generate a random code table of 360 subjects, and divide them into groups according to the order of visits, and keep it from patients

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

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）：

不公开

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

The original data will be not be published

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：

临床研究人员将在CRF中记录临床信息

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

Clinical researchers will record clinical information in CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-02-17 21:39:59