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室内空气净化治疗蒿属花粉变应性鼻炎患者随机、双盲双模拟、平行对照临床试验
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注册号:

Registration number:

ChiCTR-INR-17012481 

最近更新日期:

Date of Last Refreshed on:

2017-08-26 

注册时间:

Date of Registration:

2017-08-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

室内空气净化治疗蒿属花粉变应性鼻炎患者随机、双盲双模拟、平行对照临床试验 

Public title:

Efficacy and safety of indoor air purification in the treatment of artemisia pollen allergic rhinitis: study protocol for a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

室内空气净化治疗蒿属花粉变应性鼻炎患者随机、双盲双模拟、平行对照临床试验 

Scientific title:

Efficacy and safety of indoor air purification in the treatment of artemisia pollen allergic rhinitis: study protocol for a randomized controlled trial 

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:

李莉 

研究负责人:

李莉 

Applicant:

Li Li 

Study leader:

Li Li 

申请注册联系人电话:

Applicant telephone:

+86 18992273362 

研究负责人电话:

Study leader's telephone:

+86 18992273362 

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:

1587074266@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1587074266@qq.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:

陕西省榆林市开发区榆溪大道93号榆林市第一医院 

研究负责人通讯地址:

陕西省榆林市开发区榆溪大道93号榆林市第一医院 

Applicant address:

93 Yuxi Avenue, Yulin, Shaanxi, China 

Study leader's address:

93 Yuxi Avenue, Yulin, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

719000 

研究负责人邮政编码:

Study leader's postcode:

719000 

申请人所在单位:

榆林市第一医院 

Applicant's institution:

Yulin First Hospital 

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:

201601 

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:

榆林市第一医院伦理委员会 

Name of the ethic committee:

the Ethics Committee of the First Hospital of Yulin 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

榆林市第一医院 

Primary sponsor:

Yulin First Hospital 

研究实施负责(组长)单位地址:

陕西省榆林市开发区榆溪大道93号榆林市第一医院 

Primary sponsor's address:

93 Yuxi Avenue, Yulin, Shaanxi, 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):

陕西

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

榆林市第一医院

具体地址:

陕西省榆林市开发区榆溪大道93号榆林市第一医院

Institution
hospital:

Yulin First Hospital

Address:

93 Yuxi Avenue, Yulin, Shaanxi, China

经费或物资来源:

2016榆林市科技计划项目 

Source(s) of funding:

2016 Yulin science and technology plan project 

研究疾病:

变应性鼻炎 

Target disease:

allergic 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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

对室内空气净化治疗蒿属花粉变应性鼻炎临床试验的疗效和安全性进行初步评价。 

Objectives of Study:

Studies have suggested that indoor particle filtration may improve symptoms or objective health outcomes, particularly for individuals with allergies. Little robust clinical evidence has been provided, however, for the efficacy/safety of indoor air-purification treatment. We sought to investigate, by means of a double-blind, placebo-controlled protocol, the efficacy of a high-efficiency particulate air (HEPA) purifier in reducing disease activity in the homes of AR patients allergic to the allergens produced by Artemisia pollen. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)所纳入变应性鼻炎患者的诊断标准为:i)临床症状:喷嚏、清水样涕、鼻塞、鼻痒等症状出现2项以上(含2项),每天症状持续或累计在1h以上。可伴有眼痒、结膜充血等眼部症状。ii)体征:常见鼻黏膜苍白、水肿,鼻腔水样分泌物。iii)皮肤点刺试验或过敏原血清特异性IgE检测阳性。 2)敏筛或点刺实验证实患者对蒿属花粉变应原敏感; 3)年龄18-65岁,性别不限。 4)成年人需知情同意,志愿参加研究; 5)能够按要求完成病例观察表等相关记录。 

Inclusion criteria

(1) with confirmed allergic rhinitis; (2) the patients are sensitive to artemisia pollen allergens; (3) aged 18 to 65 years; (4) informed consent and volunteer to participate the study; (5) to complete the CRF and other records. 

排除标准:

1)精神病患者; 2)研究人员认为不适合采取措施的全身性疾病者; 3)年龄<18岁,或>65岁 4)临床研究者认为参与临床研究的被试者不能配合检查时。 5)因工作环境经常变动等易造成失访的患者。 6)由于智力或行为障碍不能充分配合试验和调查者。 7)患有以下疾病的任一项:鼻息肉,慢性鼻窦炎,严重的鼻中隔偏曲,药物性鼻炎,原发性睡眠障碍>1晚/周,睡眠呼吸暂停综合征,2周前曾有急性上呼吸道感染,控制不良的哮喘。 8)孕妇或性生活频繁不避孕患者 9)3年内有药物滥用病史 10)1年内有吸烟病史 11)不能停用抗过敏药物 12)睡眠必须需轮替不同的床频率大于6次/3周或者超过连续3晚 13)因其他原因导致研究不能继续的患者 

Exclusion criteria:

(1) psychopath; (2) the patients have systemic disease which the researchers consider unsuitable for the study; (3) not cooperated with the examination; (4) work places changed from time to time which would be lost to follow up possibly; (5) the patients have dysgnosia or behavior disorder; (6) the patients has any diseases as following: nasal polyp, chronic sinusitis, severe nasal diviation, medicamentous rhinitis, primary sleep disorders for more than one night a week, obstructive sleep apnea syndrome, upper respiratory infection within 2 weeks before enrollment, poorly controlled asthma; (7) women who are pregnant, or may possibly become pregnant, or who are lactating with a positive urine pregnant test; (8) history of drug abuse within three years; (9) necessity to sleep in a different bed more than six times in 3 weeks or more than 3 consecutive nights; (10)history of smoking within one year; (11) the patients are sensitive to indoor allergens, such as dust mite, pet dander, et al.; (12) Other reasons at the investigators discretion. 

研究实施时间:

Study execute time:

From2016-06-01To 2018-09-15 

干预措施:

Interventions:

组别:

空气净化机组

样本量:

30

Group:

active air cleaner

Sample size:

干预措施:

空气净化机治疗

干预措施代码:

Intervention:

active air cleaner treatment

Intervention code:

组别:

安慰机组

样本量:

30

Group:

Control

Sample size:

干预措施:

安慰机

干预措施代码:

Intervention:

placebo air cleaner

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

榆林市第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

Yulin First Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分表评分

指标类型:

主要指标 

Outcome:

The Visual Analog Scale (VAS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻部症状

指标类型:

次要指标 

Outcome:

the change in nasal signs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

过敏症状评分

指标类型:

次要指标 

Outcome:

allergy symptom 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:

鼻结膜炎生活质量量表评分

指标类型:

次要指标 

Outcome:

the Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Epworth嗜睡量表评分

指标类型:

次要指标 

Outcome:

Epworth Sleepiness Scale score

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:

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 years
最大 Max age 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):

郑州大学毛振兴副教授采用spss随机数字表产生随机序列

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

Mao Zhenxing, an associate professor at Zhengzhou University, uses SPSS random number tables to generate random sequences

盲法:

Blinding:

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):

通过ResMan提供原始数据查询

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

IPD will be public accessable via ResMan

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-08-26
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