ChiCTR2300076147 版本V1.1 版本创建时间2023/09/28 14:31:19 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：

 ChiCTR2300076147 

最近更新日期：

Date of Last Refreshed on：

 2023-09-26 11:20:39 

注册时间：

Date of Registration：

 2023-09-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

膝痹散外敷治疗寒湿痹阻型膝骨关节炎的随机对照临床研究

Public title：

A clinical randomized controlled study of external application of Xibisan in treating knee osteoarthritis due to cold and damp block

注册题目简写：

English Acronym：

研究课题的正式科学名称：

膝痹散外敷治疗寒湿痹阻型膝骨关节炎的随机对照临床研究

Scientific title：

A clinical randomized controlled studyof external application of Xibisan in treating knee osteoarthritis due to cold and damp block

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：

张云华 

研究负责人：

张云华 

Applicant：

Yunhua Zhang 

Study leader：

Yunhua Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 173 5329 9009

研究负责人电话：

Study leader's
telephone：

+86 173 5329 9009

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：

 yunhua_2008@163.com.cn

研究负责人电子邮件：

Study leader's E-mail：

 yunhua_2008@163.com.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 中国重庆市南川区卫生健康委员会 - 重庆市南川区中医医院

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：

中国重庆市南川区隆化大道15号

研究负责人通讯地址：

中国重庆市南川区隆化大道15号

Applicant address：

15 Longhua Dadao, Nanchuan District, Chongqing,China

Study leader's address：

15 Longhua Dadao, Nanchuan District, Chongqing,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：

中国重庆市南川区中医医院

Applicant's institution：

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

研究负责人所在单位：

中国重庆市南川区中医医院

Affiliation of the Leader：

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023-NZYLL01-01

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：

重庆市南川区中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-13 00:00:00

伦理委员会联系人：

丁霞

Contact Name of the ethic committee：

Ding Xia

伦理委员会联系地址：

中国重庆市南川区隆化大道15号

Contact Address of the ethic committee：

15 Longhua Dadao, Nanchuan District, Chongqing,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 7142 3365

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：

中国重庆市南川区中医医院

Primary sponsor：

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国重庆市南川区隆化大道15号

Primary sponsor's address：

15 Longhua Dadao, Nanchuan District, Chongqing,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)：

重庆市

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆市卫生健康委员会

具体地址：

中国重庆渝北区旗龙路6号

Institution
hospital：

Chongqing Municipal Health Commission

Address：

6 Qilong Road, Yubei District, Chongqing, China

经费或物资来源：

2023年重庆市科卫联合医学科研项目

Source(s) of funding：

2023 Science and Technology Bureau and Health Commission joint medical scientific research project

研究疾病：

原发性膝骨关节骨关节炎  

Target disease：

Knee Osteoarthritis

研究疾病代码：

FA01.0

Target disease code：

FA01.0

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

膝骨关节炎（KOA）是一种严重影响中老年人生活质量的慢性退行性骨关节疾病，属中医“痹证”痿证”范畴。作为中医骨伤科的优势病种之一,中医药治疗方法在 KOA 的临床治疗中发挥了重要作 用。全国名老中医郭剑华主任医师自创的膝痹消熏洗经验方，应用临床多年，效果满意，我科在此方基础上加减，制成散剂（命名为膝痹散）外敷，更方便患者使用，为切实论证其疗效，亟需 通过高质量的前瞻性研究进行科学验证，为后续分析其具体有效成分和作用机制从而优化疗效提供基础。  

Objectives of Study：

Knee osteoarthritis (KOA) is a kind of chronic degenerative bone and joint disease which seriously affects the quality of life of middle-aged and elderly people. It belongs to the category of "Bi syndrome". As one of the dominant diseases in orthopaedics Department of traditional Chinese medicine, traditional Chinese medicine has played an important role in the clinical treatment of KOA. Guo Jianhua, chief physician of the national famous traditional Chinese medicine, created the experience prescription of Xibixiao fumigation and washing, which has been applied clinically for many years with satisfactory results. Based on the addition and subtraction of this prescription, our department makes the powder (named Xibi Powder) for external application, which is more convenient for patients to use. In order to effectively demonstrate its curative effect, it is urgent to conduct scientific verification through high-quality prospective research. To provide a basis for further analysis of its specific active components and mechanism of action to optimize the curative effect.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1: ①原发性 KOA，符合上述中医诊断和西医诊断标准； ②X 线分级符合 Kellgren＆Lawrance Ｘ线分级 I～III 级； ③45 岁≤年龄≤80 岁，体重、性别不限； ④未进行过系统治疗，包括膝关节手术及玻璃酸钠注射。 ⑤受试者知情，并签署书面知情同意书。

Inclusion criteria

1: 1.Primary KOA, in line with the above diagnostic criteria of Chinese medicine and Western medicine 2: 2. The X-ray grading conforms to Kellner &Lawrance X-ray grading I ~ III 3: 3. age between 45 -80, weight and gender were not limited 4: 4. Haven’t been recieved systematic treatment, including knee surgery and sodium hyaluronate injection. 5: 5.The subject is informed and signs a written informed consent.

排除标准：

1: ①合并其他膝关节疾病，如痛风性关节炎、类风湿关节炎、色素绒毛沉着结节样滑膜炎、 创伤性关节炎等； ②合并有代谢性骨病、肿瘤、创伤等波及膝关节者； ③本次治疗前 1 个月前服用过非甾体类抗炎药（NSAIDs）者和（或）关节腔注射药物者； ④患病膝关节 1 年内行手术治疗者，如关节清洗术等； ⑤合并严重内科疾患和精神病患者； ⑥有消化道出血病史患者； ⑦妊娠、计划妊娠或哺乳期妇女； ⑧有研究药物过敏者； ⑨ 长期服用其它影响安全性和疗效判定药物的患者。

Exclusion criteria：

1: 1.Combined with other knee diseases, such as gouty arthritis, rheumatoid arthritis, pigmented villous nodular synovitis, traumatic arthritis, etc. 2: 2.Patients with metabolic bone disease, tumor, trauma, etc. affecting knee joint 3: 3.Patients who had taken non-steroidal anti-inflammatory drugs (NSAIDs) and/or injected drugs into the joint cavity 1 month before the current treatment 4: 4.Patients who received surgical treatment within 1 year, such as joint cleaning 5: 5.patients with severe medical disease and mental illness 6: 6.Patients with a history of gastrointestinal bleeding 7: 7.Women who are pregnant, planning to be pregnant or lactating 8: 8.There are studies of drug allergy 9: 9.Patients with long-term use of other drugs that affect safety and efficacy evaluation.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-06 00:00:00 至 To 2024-05-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 40

Group：

Experimental group

Sample size：

干预措施：

取研磨成细末的中药粉 50g，用80℃水和2g凡士林调成糊状，待温度降至低于皮温后，直接涂于患处，面积要稍大于关节部位，厚度约 3mm，外用绷带固定，每日患处贴敷1 次，1 次贴敷 4~6h，连续治疗 2 周。

干预措施代码：

Intervention：

Take 50g of finely ground Chinese medicine powder, and make paste with 80℃ water and 2g Vaseline. When the temperature drops below the skin temperature, apply it directly to the affected area, slightly larger than the joint, with a thickness of about 3mm, and fix it with external bandages. Apply it once a day to the affected area, once for 4~6h, and continuously treat for 2 weeks.

Intervention code：

组别：

对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

对照组使用 PE 塑料膜分隔药物与皮肤的接触，按试验组方法外敷膝痹散，其外形、触感及气味均同实验组一致。

干预措施代码：

Intervention：

The control group used PE plastic film to separate the contact between the drug and the skin, and the knee Bi powder was applied externally according to the method of the experimental group, and its appearance, touch and smell were consistent with that of the experimental group.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆市南川区中医医院 

单位级别：

 三级 

Institution
hospital：

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

WOMAC 骨关节炎指数

指标类型：

主要指标

Outcome：

WOMAC Osteoarthritis Index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟量表VAS

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：

中医证候积分

指标类型：

主要指标

Outcome：

Traditional Chinese Medicine Syndrome Points

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

核磁、彩超、C 反应蛋白、血沉

指标类型：

次要指标

Outcome：

Magnetic resonance imaging, color Doppler ultrasound, C-reactive protein, erythrocyte sedimentation rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮肤过敏、瘙痒或疼痛等可能不良反应的发生率

指标类型：

次要指标

Outcome：

The incidence of possible adverse reactions such as skin allergies, itching, or pain

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：

None

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 45 岁 years
最大 Max age 80 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）：

团队专人采用电脑随机生成1-80个数字中的40个数字，与剩下的40个数字分别定义为试照组和对照组，按就诊的先后顺序编码，纳入的研究对象随机从抽号箱内抽取1-80个数字中一个数字，根据抽取数字决定分在对应的组别，每组各40例。

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

40 of the 1-80 numbers were randomly generated by the computer, and the remaining 40 numbers were defined as the trial group and the control group respectively. The numbers were coded according to the sequence of medical treatment. The included subjects were randomly selected from a number box to select one of the 1-80 numbers and were divided into corresponding groups according to the extracted numbers, with 40 cases in each group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究对患者及除治疗师外的研究人员设盲

Blinding：

This study blinded patients and researchers other than therapists

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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, http://www.medresman.org.cn/login.aspx

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

ResMan, http://www.medresman.org.cn/login.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：

研究者根据受试者的原始观察记录，将数据及时、完整、准确、清晰的载入病例报告表。录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍比对。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防治损坏。

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

According to the original observation records of the subjects, the researcher will timely, complete, accurate and clear data into the case report form. The corresponding database system was used for two-person and two-machine input, and then the database was compared twice. Electronic data files are stored in different types, and multiple backups are stored on different disks or recording media. Keep them properly to prevent damage.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-09-26 11:20:34