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穴位埋线治疗变应性鼻炎的随机对照试验
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注册号:

Registration number:

ChiCTR-TRC-12002191 

最近更新日期:

Date of Last Refreshed on:

2015-08-13 

注册时间:

Date of Registration:

2012-05-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

穴位埋线治疗变应性鼻炎的随机对照试验 

Public title:

A Randomized, Sham-Controlled Trial of Catgut Implantation at Acupoints for the Treatment of Allergic Rhinitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

穴位埋线治疗变应性鼻炎的随机对照试验 

Scientific title:

A Randomized, Sham-Controlled Trial of Catgut Implantation at Acupoints for the Treatment of Allergic Rhinitis 

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:

李昕蓉 

研究负责人:

张勤修 

Applicant:

LI Xin-rong 

Study leader:

ZHANG Qin-xiu 

申请注册联系人电话:

Applicant telephone:

+86 13981767185 

研究负责人电话:

Study leader's telephone:

+86 18980880173 

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:

amz.3@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhqinxiu@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:

成都市静安路一号万科城市花园9A202 

研究负责人通讯地址:

成都市金牛区十二桥路39号成都中药大学附属医院耳鼻喉科 

Applicant address:

9A202, Wanke City Garden, 1 Jingan Road, Jinjiang District, Chengdu, China 

Study leader's address:

Department of Otorhinolaryngology -Head and Neck Surgery of Teaching Hospital of Chengdu University of Traditional Chinese Medicine, 39 Shi-er-qiao Road, Jinniu District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610066 

研究负责人邮政编码:

Study leader's postcode:

610072 

申请人所在单位:

成都中医药大学 

Applicant's institution:

Chengdu University 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:

四川中医药区域伦理审查委员会2012KL-002 

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:

四川中医药区域伦理审查委员会 

Name of the ethic committee:

Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-05-13 

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:

成都中医药大学附属医院 

Primary sponsor:

Teaching Hospital of Chengdu University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

成都市金牛区12桥路39号 

Primary sponsor's address:

39 Shi-er-qiao Road, Jinniu District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

成都金牛区12桥路39号

Institution
hospital:

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Shi-er-qiao Road, Jinniu District, Chengdu, Sichuan, China

经费或物资来源:

中央财政支持地方高校发展专项资金特色重点学科,财教【2010】353号 

Source(s) of funding:

Central finance to support the development of special key discipline of local colleges and universities, No.(2010)353 of the Fiancal grogram for education 

研究疾病:

变应性鼻炎 

Target disease:

alleigic rhinitis 

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:

其它 

Study phase:

N/A 

研究目的:

研究穴位埋线治疗变应性鼻炎的临床疗效及安全性 

Objectives of Study:

This study aims to identify whether catgut implantation is an effective and safe treatment for AR 

药物成份或治疗方案详述:

无 

Description for medicine or protocol of treatment in detail:

There is not any new drug or experimental drug that will be used in this trial. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

根据ARIA(2008),变应性鼻炎的诊断标准包括:(1)有典型的变应性鼻炎症状:鼻溢液、喷嚏、鼻塞,某些患者对于户外过敏原还有眼痒不适等症状;(2)皮肤变应原点刺试验;(3)血清特异性IgE检测。 本次试验纳入患者标准为 1. 符合变应性鼻炎诊断标准者 2. 年龄在18-70岁之间 3. 有两年以上变应性鼻炎的病史,符合本次试验变应性鼻炎的诊断标准 4. 过敏原皮肤点刺试验证实至少有一种变应原阳性 

Inclusion criteria

According to ARIA (2008 Update), the diagnostic criteria for allergic rhinitis is based upon the coordination between a typical history of allergic symptoms and diagnostic tests. They are: 1. Typical symptoms of allergic rhinitis: rhinorrhoea, sneezing, nasal obstruction and pruritus. Some patients may have ocular symptoms for outdoor allergens. 2. Prick and puncture tests performed by trained health professionals. 3. The blood specific IgE. The time when subjects have above symptoms should last more than one hour on most days. Standardized vaccines (Alutard SQ, ALK- Abelló, Denmark) are used in the test. Oral H1-antihistamines are not permitted before skin test. And skin tests should be read at the peak of their reaction by measuring the wheal and the flare approximately 15 min after the performance of the test.1 Patients who meet the diagnosis of allergic rhinitis will be included in this study. The criteria are: (1) aged between 18-70 years; (2) not be taking part in any other clinical trials; (3) having no previous experience of catgut implantation at acupoints; (4) provide written informed consent. 

排除标准:

1. 妊娠或哺乳期、月经期妇女;计划半年内怀孕的妇女 2. 接受免疫治疗的患者; 3. 合并有哮喘、过敏性紫癜等其他过敏性疾病的患者;鼻息肉患者; 4. HIV患者; 5. 对鸡蛋等异种蛋白过敏的患者 6. 曾接受过穴位埋线治疗的患者 7. 合并严重的心脑血管疾病、肝、肾、血液系统疾病患者或恶性肿瘤,精神病患者、糖尿病患者,有出血倾向的患者。 8. 未能签署试验知情同意书的患者 

Exclusion criteria:

Patients with any of the following conditions will be excluded: (1) pregnant women or women who are ready to be pregnant in recent half year, women with lactation; (2) patients are receiving immune therapy; (3) patients with other allergic diseases, such as bronchial asthma or allergic purpura; (4) patients with nasal polyposis; (5) heterologous protein allergy; (6) patients with other organic disorders, such as: AIDS, vascular malformation, hypertension, hematologic diseases, diabetes mellitus, malignant tumor, mental disorder; (7) patients with previous experiences of catgut implantation at acupoints; (8) patients who are unwilling to provide written informed consent. 

研究实施时间:

Study execute time:

From2012-12-01To 2013-12-01 

干预措施:

Interventions:

组别:

试验组

样本量:

64

Group:

real catgut implantation at acupoints group

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

catgut implantation at acupoints

Intervention code:

组别:

对照组

样本量:

64

Group:

controlled group

Sample size:

干预措施:

假埋线

干预措施代码:

Intervention:

sham catgut implantation at acupoints

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Teaching Hospital of Chengdu University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

鼻症状VAS评分量表

指标类型:

主要指标 

Outcome:

Visual analog scale for the measurement of severity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

sf-36生活质量评分量表

指标类型:

主要指标 

Outcome:

SF-36 questionaire of QOL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清特异性IgE

指标类型:

主要指标 

Outcome:

serum allergen-specific IgE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻腔炎性细胞计数(嗜酸性粒细胞,肥大细胞,嗜碱性粒细胞)

指标类型:

主要指标 

Outcome:

nasal inflammatory cells counts(mast cells, eosinophils, basophils)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓解药物使用评分

指标类型:

次要指标 

Outcome:

relief medication score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

副反应评分

指标类型:

副作用指标 

Outcome:

side effects scores

Type:

Adverse events 

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:

血液

组织:

Sample Name:

blood

Tissue:

no

人体标本去向

使用后销毁 

说明

保存一周

Fate of sample:

Destruction after use 

Note:

preserved for1 week

标本中文名:

鼻分泌物

组织:

Sample Name:

nasal secretion

Tissue:

no

人体标本去向

使用后销毁 

说明

保存一周

Fate of sample:

Destruction after use 

Note:

preserved for1 week

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

SPSS17.0计算机软件产生随机数字与序号。专人确定随机数字的分组,确定并记录分组信息。此人不再参与纳入受试者

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

Randomized numbers and the allocation sequences would be generated by computer( software of SPSS1

盲法:

盲法的实施和隐藏: ① 在盲法实施的过程中,由不参与试验的“第三方”人员进行管理和监督 ② 计算机产生的随机数字放于不透光的信封里,患者按入选试验的先后顺序领取信封,不得拆开信封。在揭盲以前试验组和对照组分别命名为A组和B组。 ③ 每位患者的穴位埋线治疗均单独进行。所有穴位埋线的过程均由同一位医生实施。埋线时,针灸医生不能与患者就埋线的具体过程方法做太多的交流。这样保证整个试验过程中患者不知晓自己被采取了何种干预措施。

Blinding:

The allocation numbers will be printed in triplicate and sealed in opaque envelope respectively. The opaque envelopes should be preserved separately by subject leader, primary sponsor, and statistician. All the envelopes must be kept intact until cease blinding. Patients who meet the inclusion criteria will be referred to acupuncturists and choose one of the opaque envelope ,then be allocated to either of the two groups. Participants, researchers, assessors and the practitioner who performed the diagnosis are blinded to the group assignments. Because the acupuncturists are responsible for treatment proceeding and collecting correlative notices of both groups, it would not be practical to blind the acupuncturists to treatment allocations. But acupuncturists should not communicate with the participants about treatment procedures to keep them blinded. This procedure assures that randomization will not be influenced, neither by the acupuncturists or the patients. To assist with the blindi

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:

即时公开/Real time access

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):

成都中医药大学附属医院

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

Chengdu University of Traditional Chinese Medicine

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:

成都中医药大学附属医院

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

Chengdu University of Traditional Chinese Medicine

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-05-09
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