骨伤搽剂治疗关节及软组织损伤的临床疗效观察

注册号:

Registration number:

ITMCTR2025001294

最近更新日期:

Date of Last Refreshed on:

2025-06-27

注册时间:

Date of Registration:

2025-06-27

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

骨伤搽剂治疗关节及软组织损伤的临床疗效观察

Public title:

Clinical efficacy observation of Gushang Liniment in the treatment of joint and soft tissue injuries

注册题目简写:

English Acronym:

研究课题的正式科学名称:

骨伤搽剂治疗关节及软组织损伤的临床疗效观察

Scientific title:

Clinical efficacy observation of Gushang Liniment in the treatment of joint and soft tissue injuries

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:

杨阳

研究负责人:

杨阳

Applicant:

Yang Yang

Study leader:

Yang Yang

申请注册联系人电话:

Applicant telephone:

+86 187 9542 5217

研究负责人电话:

Study leader's telephone:

+86 187 9542 5217

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:

newyyang@163.com

研究负责人电子邮件:

Study leader's E-mail:

newyyang@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:

江苏省徐州市铜山路236号医院药剂科

研究负责人通讯地址:

江苏省徐州市铜山路236号医院药剂科

Applicant address:

Department of Pharmacy the 71st Group Army Hospital of the Chinese PLA Army No. 236 Tongshan Road Xuzhou City Jiangsu Province of China

Study leader's address:

Department of Pharmacy the 71st Group Army Hospital of the Chinese PLA Army No. 236 Tongshan Road Xuzhou City Jiangsu Province of China

申请注册联系人邮政编码:

Applicant postcode:

221004

研究负责人邮政编码:

Study leader's postcode:

221004

申请人所在单位:

中国人民解放军陆军第七十一集团军医院

Applicant's institution:

the 71st Group Army Hospital of the Chinese PLA Army

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:

LL-2025YX08

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国人民解放军陆军第七十一集团军医院医学伦理委员会

Name of the ethic committee:

the Medical Ethic Committee of the 71st Group Army Hospital of the Chinese PLA Army

伦理委员会批准日期:

Date of approved by ethic committee:

2025/4/16 0:00:00

伦理委员会联系人:

刘焕

Contact Name of the ethic committee:

Liu Huan

伦理委员会联系地址:

江苏省徐州市铜山路236号陆军第七十一集团军医院

Contact Address of the ethic committee:

the 71st Group Army Hospital of the Chinese PLA Army No. 236 Tongshan Road Xuzhou City Jiangsu Province of China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 051667349015

伦理委员会联系人邮箱:

Contact email of the ethic committee:

1143407234@qq.com

研究实施负责(组长)单位:

中国人民解放军陆军第七十一集团军医院

Primary sponsor:

the 71st Group Army Hospital of the Chinese PLA Army

研究实施负责(组长)单位地址:

江苏省徐州市铜山路236号

Primary sponsor's address:

No. 236 Tongshan Road Xuzhou Jiangsu 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):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

中国人民解放军陆军第七十一集团军医院

具体地址:

江苏省徐州市铜山路236号

Institution
hospital:

the 71st Group Army Hospital of the Chinese PLA Army

Address:

No. 236 Tongshan Road Xuzhou Jiangsu China

经费或物资来源:

医院自筹

Source(s) of funding:

Hospital self financed

研究疾病:

关节及软组织损伤

研究疾病代码:

Target disease:

Joint and soft tissue injuries

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:

其它

Others

研究目的:

观察骨伤搽剂治疗关节及软组织损伤的临床疗效。

Objectives of Study:

To observe the clinical efficacy of Gushang Liniment in the treatment of joint and soft tissue injuries.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

患者符合四肢软组织损伤,膝、踝关节扭伤、腕关节扭伤等关节及软组织损伤诊断标准,均有患部疼痛、肿胀、活动受限等症状。未经内服、外敷治疗药物以及其它方法治疗者;年龄在18岁~60岁之间;无神经、血管损伤;无心、肝、肾、造血系统疾病以及精神病、结核、肿瘤等疾病。自愿签署知情同意书加入本次试验。

Inclusion criteria

Patients meeting the diagnostic criteria for limb soft tissue injuries including sprains of the knee ankle and wrist joints presenting with localized pain swelling and restricted range of motion. Eligible participants were aged 18–60 years with no prior use of oral or topical pharmacotherapy or alternative treatments. Exclusion of individuals with neurovascular impairment cardiovascular hepatic renal or hematopoietic disorders as well as psychiatric conditions tuberculosis or malignancies. All participants provided written informed consent prior to enrollment.

排除标准:

患者年龄在17岁以下或60岁以上者;以往患有严重心、肝、脾、肺、肾等疾病的患者;处于妊娠期或哺乳期的妇女;治疗过程未遵医嘱用药或不宜继续用药者;无法判断疗效或资料不全等影响疗效或者安全性判断者;发生严重不良事件或发生并发症或特殊生理变化不宜继续接受试验者;患者主动要求退出研究,或患者在未完成全部治疗前不再接受用药或检测者。具备以上任何一项者予以排除。

Exclusion criteria:

Exclusion criteria comprised: age <17 or >60 years; history of severe cardiac hepatic splenic pulmonary or renal dysfunction; pregnancy or lactation; non-adherence to prescribed treatment regimens; inability to assess efficacy due to incomplete data or confounding factors; occurrence of severe adverse events (SAEs) complications or physiological alterations necessitating trial discontinuation; voluntary withdrawal or premature termination of treatment or follow-up assessments.

研究实施时间:

Study execute time:

From 2025-01-01

To      2026-01-31

征募观察对象时间:

Recruiting time:

From 2025-08-01

To      2025-12-31

干预措施:

Interventions:

组别:

骨伤搽剂组

样本量:

40

Group:

Gushang Liniment group

Sample size:

干预措施:

伤后48 h,在常规治疗的基础上加用骨伤搽剂(药量视骨伤部位范围大小而定),外涂损伤部位,1次/10分钟,每日3~4次。

干预措施代码:

Intervention:

At 48 hours post-injury Gushang Liniment (dosage adjusted per lesion size) was applied topically to the affected site every 10 minutes (3–4 times daily) alongside standard care.

Intervention code:

组别:

常规治疗组

样本量:

40

Group:

Conventional treatment group

Sample size:

干预措施:

口服艾瑞昔布胶囊等常规治疗药物,0.1 g/粒,口服,2次/日。

干预措施代码:

Intervention:

Oral imrecoxib (0.1 g/capsule BID).

Intervention code:

组别:

筋骨伤喷雾剂组

样本量:

40

Group:

Jingushang Spray group

Sample size:

干预措施:

伤后48 h,在常规治疗的基础上加用筋骨伤喷雾剂(药量视骨伤部位范围大小而定),喷涂损伤部位,1次/10分钟,每日3~4次。

干预措施代码:

Intervention:

At 48 hours post-injury Jingushang Spray (dosage adjusted per lesion size) was applied topically to the affected site every 10 minutes (3–4 times daily) alongside standard care.

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

中国人民解放军陆军第七十一集团军医院

单位级别:

三甲

Institution/hospital:

the 71st Group Army Hospital of the Chinese PLA Army

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

淤血消除时间

指标类型:

次要指标

Outcome:

Bruising elimination time

Type:

Secondary indicator

测量时间点:

随时

测量方法:

观察并记录

Measure time point of outcome:

At any time

Measure method:

Observe and record

指标中文名:

白细胞分类

指标类型:

次要指标

Outcome:

White blood cell differential

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

指标中文名:

临床疗效

指标类型:

主要指标

Outcome:

Clinical efficacy

Type:

Primary indicator

测量时间点:

治疗后第14日

测量方法:

观察并记录

Measure time point of outcome:

On the 14th days after treatment

Measure method:

Observe and record

指标中文名:

行动情况

指标类型:

次要指标

Outcome:

Mobility status

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第4日、第7日、第10日、第14日

测量方法:

观察并记录

Measure time point of outcome:

Before treatment and on the 4th, 7th, 10th and 14th days after treatment

Measure method:

Observe and record

指标中文名:

白细胞计数

指标类型:

次要指标

Outcome:

White blood cell (WBC) count

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

指标中文名:

红细胞计数

指标类型:

次要指标

Outcome:

Red blood cell (RBC) count

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

指标中文名:

血清C反应蛋白含量

指标类型:

次要指标

Outcome:

Serum c-reactive protein (CRP) level

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

指标中文名:

关节功能分级

指标类型:

次要指标

Outcome:

Joint function grading

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第4日、第7日、第10日、第14日

测量方法:

观察并记录

Measure time point of outcome:

Before treatment and on the 4th 7th 10th and 14th days after treatment

Measure method:

Observe and record

指标中文名:

淤血程度

指标类型:

次要指标

Outcome:

Bruising severity

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第4日、第7日、第10日、第14日

测量方法:

观察并记录

Measure time point of outcome:

Before treatment and on the 4th 7th 10th and 14th days after treatment

Measure method:

Observe and record

指标中文名:

NRS疼痛评分

指标类型:

次要指标

Outcome:

Pain score (NRS)

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第4日、第7日、第10日、第14日

测量方法:

观察并记录

Measure time point of outcome:

Before treatment and on the 4th 7th 10th and 14th days after treatment

Measure method:

Observe and record

指标中文名:

肿胀程度

指标类型:

次要指标

Outcome:

Swelling severity

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第4日、第7日、第10日、第14日

测量方法:

观察并记录

Measure time point of outcome:

Before treatment and on the 4th 7th 10th and 14th days after treatment

Measure method:

Observe and record

指标中文名:

疼痛消除时间

指标类型:

次要指标

Outcome:

Pain elimination time

Type:

Secondary indicator

测量时间点:

随时

测量方法:

观察并记录

Measure time point of outcome:

At any time

Measure method:

Observe and record

指标中文名:

药物不良反应

指标类型:

副作用指标

Outcome:

Adverse drug reactions

Type:

Adverse events

测量时间点:

随时

测量方法:

观察并记录

Measure time point of outcome:

At any time

Measure method:

Observe and record

指标中文名:

肿胀消除时间

指标类型:

次要指标

Outcome:

Swelling elimination time

Type:

Secondary indicator

测量时间点:

随时

测量方法:

观察并记录

Measure time point of outcome:

At any time

Measure method:

Observe and record

指标中文名:

血小板计数

指标类型:

次要指标

Outcome:

Platelet count

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

指标中文名:

血清血沉

指标类型:

次要指标

Outcome:

Serum erythrocyte sedimentation rate (ESR)

Type:

Secondary indicator

测量时间点:

治疗前及治疗后第7日、第14日

测量方法:

检测患者外周血

Measure time point of outcome:

Before treatment and on the 7th and 14th days after treatment

Measure method:

Detection of peripheral blood of patients

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

No

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 18
Min age years
最大 60
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):

研究人员通过IBM SPSS Statistics 21.0软件生成完全随机数字与序号。

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

Complete random numbers and serial numbers were generated by an investigator through IBM SPSS Statistics 21.0 software.

盲法:

Blinding:

None

是否共享原始数据:

IPD sharing:

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/register.aspx)。

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

Resman Clinical Trial Management Public Platform (http://www.medresman.org.cn/register.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:

数据采集使用病例记录表,数据管理采用SPSS软件表格。

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

Case record forms are used for data collection and SPSS software are used for data management.

数据管理委员会:

Data Managemen Committee:

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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