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中药复方青痹颗粒外用治疗中医热痹的临床方案优化及疗效再评价
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注册号:

Registration number:

ChiCTR1800018020 

最近更新日期:

Date of Last Refreshed on:

2018-08-27 

注册时间:

Date of Registration:

2018-08-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中药复方青痹颗粒外用治疗中医热痹的临床方案优化及疗效再评价 

Public title:

Clinical plan optimization and curative effect re-evaluation of Chinese herbal compound Qing Bi granule for external application of heat syndrome in TCM 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中药复方青痹颗粒外用治疗中医热痹的临床方案优化及疗效再评价 

Scientific title:

Clinical plan optimization and curative effect re-evaluation of Chinese herbal compound Qing Bi granule for external application of heat syndrome in TCM 

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:

任爽 

研究负责人:

张杰 

Applicant:

Shuang Ren 

Study leader:

Jie Zhangg 

申请注册联系人电话:

Applicant telephone:

+86 18840054585 

研究负责人电话:

Study leader's telephone:

+86 13998324161 

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:

116017440@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangjie945@126.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:

辽宁省沈阳市和平区南京北街155号 

研究负责人通讯地址:

辽宁省沈阳市和平区南京北街155号 

Applicant address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, China 

Study leader's address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, 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:

110001 

申请人所在单位:

中国医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of China Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市和平区南京北街155号 

Primary sponsor's address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

liaoning

City:

shenyang

单位(医院):

中国医科大学附属第一医院

具体地址:

辽宁省沈阳市和平区南京北街155号

Institution
hospital:

First Affiliated Hospital of China Medical University

Address:

155 Nanjing Street North, Heping District, Shenyang

经费或物资来源:

辽宁省中医药管理局 

Source(s) of funding:

Liaoning Provincial Administration of Traditional Chinese Medicine 

研究疾病:

骨关节病 

Target disease:

Osteoarthrosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

采用前沿的MRI及超声等客观化评价指标,探讨复方青痹颗粒在起效时间,改善症状(疼痛、红肿)等方面与西药扶他林乳胶剂相对比的临床优势,以期提供一种简便廉验的外治疗法和剂型,为中医传统外治法在临床应用中提供方法和依据。 

Objectives of Study:

Using the objective evaluation indicators such as MRI and ultrasound at the front, to explore the clinical advantages of Chinese herbal compound Qing Bi granule in comparison with the western medicine Futalin emulsion in terms of onset time and improvement of symptoms (pain, redness and swelling), in order to provide a simple and inexpensive test. External treatment methods and dosage forms provide methods and basis for clinical application of traditional Chinese medicine external treatment. 

药物成份或治疗方案详述:

复方青痹颗粒组(试验组)给予复方青痹颗粒外敷关节患处。将药物研成粉末,取50g 加温水20ml、蜂蜜 5g 调匀,用纱布包裹,敷于关节患处,每次 1-2 小时,每日1次,每周7日,疗程28天,随访4周。扶他林乳胶剂组(对照组)给予扶他林乳胶剂外用于关节患处,每日3次,每周7日,疗程28天,随访4周。 

Description for medicine or protocol of treatment in detail:

The compound Qing Bi granules group (test group) was given the compound Qing Bi granules for external application of joints. The drug is ground into a powder, 50g warm water 20ml, honey 5g and mix thoroughly, wrapped with gauze, applied to the joint affected area, 1-2 hours each time, once a day, 7 days a week, 28 days of treatment, followed up for 4 weeks. The Futalin Latex Group (control group) was given to the joint affected area by the Futalin Latex, 3 times a day, 7 days a week, 28 days of treatment, followed up for 4 weeks. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄:18-75岁(包括18岁和75岁); 2.西医符合类风湿关节炎、膝骨关节炎或急性痛风关节炎的诊断标准; 3.中医符合热痹的诊断标准:关节疼痛,局部红肿灼热,痛不可触,屈伸不利,得冷稍舒者,均可诊断为热痹。临床可伴有发热恶风,多汗,心烦口渴;舌红苔黄,脉滑数; 4.签署知情同意书者; 5.急性起病,本次发作病程在48小时内。 

Inclusion criteria

1. Aged 18 to 75 years old male and female with rheumatoid arthritis, knee osteoarthritis or acute gout arthritis; 2. With Chinese medicine Re-Bi symptom include joint pain, local redness and burning, pain can not touch, unfavorable flexion and extension, can be diagnosed as enthusiasm. Clinically, it can be accompanied by fever, bad wind, sweating, upset and thirst; red tongue yellow, slippery pulse; 3. sign the informed consent form; 4. Acute onset, the duration of this episode is within 48 hours. 

排除标准:

1.妊娠或哺乳的女性患者; 2.有心、脑血管、肝脏、肾脏和造血系统的严重原发性疾病及精神病患者,或伴有严重关节外表现,例如高热(体温>38°)不退等; 3.正在使用糖皮质激素或生物制剂治疗者; 4.对治疗或对照药物不能耐受或出现过敏反应者。 

Exclusion criteria:

1. Female patients who are pregnant or breast-feeding; 2. Severe primary diseases and mental patients with heart, cerebrovascular, liver, kidney and hematopoietic system, or with severe extra-articular manifestations, such as high fever (body temperature > 38 degree C), etc.; 3. Those who are using glucocorticoids or biological agents; 4. Those who are intolerant or have an allergic reaction to a therapeutic or control drug. 

研究实施时间:

Study execute time:

From2018-05-01To 2020-05-01 

征募观察对象时间:

Recruiting time:

From2018-10-01To 2019-08-01 

干预措施:

Interventions:

组别:

复方青痹颗粒组

样本量:

100

Group:

Group 1

Sample size:

干预措施:

复方青痹颗粒

干预措施代码:

Intervention:

the compound Qing Bi granules

Intervention code:

组别:

扶他林乳胶剂组

样本量:

100

Group:

Group 2

Sample size:

干预措施:

扶他林乳胶剂

干预措施代码:

Intervention:

Futalin emulsion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

沈阳市 

Country:

China 

Province:

Liaoning 

City:

shenyang 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

0天、7天、14天、28天

测量方法:

问卷形式

Measure time point of outcome:

0 days, 7 days, 14 days, 28 days

Measure method:

Questionnaire form

指标中文名:

中医证候计分

指标类型:

主要指标 

Outcome:

TCM syndrome score

Type:

Primary indicator 

测量时间点:

0天、7天、14天、28天

测量方法:

问卷形式

Measure time point of outcome:

0 days, 7 days, 14 days, 28 days

Measure method:

Questionnaire form

指标中文名:

生存质量

指标类型:

主要指标 

Outcome:

Quality of life

Type:

Primary indicator 

测量时间点:

0天、7天、14天、28天

测量方法:

问卷形式

Measure time point of outcome:

0 days, 7 days, 14 days, 28 days

Measure method:

Questionnaire form

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

ESR

Type:

Primary indicator 

测量时间点:

0天、7天、14天、28天

测量方法:

ELISA法

Measure time point of outcome:

0 days, 7 days, 14 days, 28 days

Measure method:

ELISA

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C-reactive protein

Type:

Primary indicator 

测量时间点:

0天、7天、14天、28天

测量方法:

ELISA法

Measure time point of outcome:

0 days, 7 days, 14 days, 28 days

Measure method:

ELISA

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine examination

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

比色法

Measure time point of outcome:

0 day, 28 days

Measure method:

Colorimetric method

指标中文名:

尿常规

指标类型:

主要指标 

Outcome:

Urine routine

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

比色法

Measure time point of outcome:

0 day, 28 days

Measure method:

Colorimetric method

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

ALT AST

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

比色法

Measure time point of outcome:

0 day, 28 days

Measure method:

Colorimetric method

指标中文名:

肾功能

指标类型:

主要指标 

Outcome:

BUN,Cr

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

比色法

Measure time point of outcome:

0 day, 28 days

Measure method:

Colorimetric method

指标中文名:

骨骼肌肉超声

指标类型:

主要指标 

Outcome:

Skeletal muscle ultrasound

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

超声检查

Measure time point of outcome:

0 day, 28 days

Measure method:

Ultrasound

指标中文名:

关节核磁共振

指标类型:

主要指标 

Outcome:

Joint magnetic resonance

Type:

Primary indicator 

测量时间点:

0天、28天

测量方法:

核磁共振

Measure time point of outcome:

0 day, 28 days

Measure method:

magnetic resonance

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

采用DAS临床试验中央随机系统(DAS for IWRS)申请随机号和配发药物,采用密封的、不透光的、按序列编码的信封,参加临床试验的医生根据密封的信封内随机产生的治疗进行分配。

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

The DAS for Central Randomized System (DAS for IWRS) was used to apply for random numbers and dispensed drugs, using sealed, opaque, sequence-encoded envelopes, and doctors participating in clinical trials performed treatment based on randomly generated treatments in sealed envelopes. distribution.

盲法:

采用DAS临床试验中央随机系统(DAS for IWRS)申请随机号和配发药物,采用密封的、不透光的、按序列编码的信封,由与本临床试验的临床观察、监查、统计分析等无关的人员,根据已形成的处理编码将相应的药物编号贴在药品外部包装醒目位置。参加临床试验的医生根据密封的信封内随机产生的治疗进行分配。

Blinding:

Use the DAS clinical trial central random system (DAS for IWRS) to apply for random numbers and dispensed drugs, using sealed, opaque, sequence-encoded envelopes, clinical observation, monitoring, statistical analysis, etc. from this clinical trial. Unrelated personnel, according to the formed processing code, the corresponding drug number is attached to the prominent position of the external packaging of the drug. Doctors participating in clinical trials are assigned according to treatments that are randomly generated within a sealed envelope.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验结束后6个月的年月,方式待完善

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

six months after the end of the trial, the way to be improved

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:

一为病例记录表(Case Record Form, CRF),二为一种基于互联网的EDC,采用revman数据管理系统

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

One is the Case Record Form (CRF), and the other is an Internet-based EDC using the revman data management system.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-08-27
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