通窍益肺针灸法治疗变应性鼻炎的临床研究方案

注册号:

Registration number:

AMCTR-IPR-20000327 

注册号获得时间:

Date of releasing the registration number:

2020/2/21 10:54:41 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

通窍益肺针灸法治疗变应性鼻炎的临床研究方案 

Public title:

A clinical study on the treatment of allergic rhinitis by tongqiao-yifei acupuncture 

研究课题的正式科学名称:

通窍益肺针灸法治疗变应性鼻炎的临床研究方案 

Scientific title:

A clinical study on the treatment of allergic rhinitis by tongqiao-yifei acupuncture 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

刘新 

研究负责人:

杜元灏 

Applicant:

Liu-Xin 

Study leader:

Du-Yuanhao 

申请注册联系人电话:

Applicant telephone:

13933901032 

研究负责人电话:

Study leader's telephone:

13821820885 

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:

labixiaoxin505@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jpjs_cn@sina.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:

河北省秦皇岛市北戴河区东经路198号 

研究负责人通讯地址:

天津市西青区昌凌路88号 

Applicant address:

198 dongjing road, beidaihe district, qinhuangdao city, hebei province, China 

Study leader's address:

No.88,changling,xiqingDistrict,Tianjing300391,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:

河北省医疗气功医院 

Applicant's institution:

Hebei Medical Qigong 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:

2019-12-006 

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:

河北省医疗气功医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Hebei Medical Qigong Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-30 

研究实施负责(组长)单位:

河北省医疗气功医院 

Primary sponsor:

Hebei Medical Qigong Hospital 

研究实施负责(组长)单位地址:

河北省秦皇岛市北戴河区东经路198号 

Primary sponsor's address:

198 dongjing road, beidaihe district, qinhuangdao city, hebei province, 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):

河北省

市(区县):

秦皇岛市

Country:

China

Province:

Hebei

City:

Qinhuangdao

单位(医院):

河北省医疗气功医院

具体地址:

河北省秦皇岛市北戴河区东经路198号

Institution
hospital:

Hebei Medical Qigong Hospital

Address:

198 dongjing road, beidaihe district, qinhuangdao city, hebei province, China

经费或物资来源:

自筹以及河北省医疗气功医院科研基金资助 

Source(s) of funding:

Self-raised and supported by the scientific research fund of Hebei Medical Qigong Hospital 

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 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

1.1评价通窍益肺针灸法治疗变应性鼻炎患者临床症状和生活质量的影响。1.2评价通窍益肺针灸法治疗变应性鼻炎的临床安全性、有效性和优效性。 

Objectives of Study:

1.1 to evaluate the effect of tongqiao-yifei acupuncture on the clinical symptoms and quality of life of patients with allergic rhinitis.1.2 to evaluate the clinical safety, effectiveness and superiority of tongqiao-yifei acupuncture in the treatment of allergic rhinitis. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)符合变应性鼻炎诊断标准;(2)年龄在 18-60 周岁之间;(3)未参加其他临床研究者;(4)自愿加入试验并填写知情同意书。 

Inclusion criteria

(1) meeting the diagnostic criteria for allergic rhinitis;(2) aged between 18 and 60;(3) not participating in other clinical researchers;(4) voluntarily join the trial and fill in the informed consent form. 

排除标准:

(1)合并有其他鼻部疾病者,如鼻中隔中重度偏曲或鼻息肉形成等;(2)2周内曾患急性上呼吸道感染,或合并有哮喘等发作性呼吸系统疾病或胸部X线片呈现炎性反应状态者;(3)1周内曾使用类固醇及抗阻胺制剂、H1-抗组胺药、抗生素、减充血剂(作用于鼻、口、眼部位)等;(4)最近一年内曾接受过特定免疫疗法或规律激素治疗;(5)两周内接受过针对本病的其他治疗;(6)哺乳期或妊娠期妇女,接受治疗过程中准备妊娠者;(7)合并有其他系统严重疾病,如:严重的高血压、冠状动脉粥样硬化性心脏病、糖尿病等基础疾病不稳定期、肝炎、结核患者或血中肌酐、谷草转氨酶/谷丙转氨酶(AST/ALT)指标超过正常值的2倍者,凝血检查提示有出血倾向者;(8)精神病患者;(9)每天吸烟10支以上,烟龄超过10年者;(10)施针部位有瘢痕者或研究人员认为应施针部位出现不适合采取措施的全身疾病者;(11)临床研究者认为参与临床研究的受试者不能配合治疗;(12)正在参加其他临床试验的患者;(13)既往有本实验相关用药及治疗措施过敏或不良反应史者。 

Exclusion criteria:

(1) patients with other nasal diseases, such as moderate and severe deviation of the nasal septum or formation of nasal polyps;(2) patients who had suffered from acute upper respiratory tract infection within 2 weeks, or were complicated with attack respiratory diseases such as asthma, or presented inflammatory responses on chest X-ray;(3) steroids and antihistamines, h1-antihistamines, antibiotics, decongestants (acting on nose, mouth and eye), etc. were used within 1 week;(4) have received specific immunotherapy or regular hormone therapy within the last year;(5) received other treatment for the disease within two weeks;(6) women who are nursing or pregnant and are preparing for pregnancy during treatment;Severe disease (7) with other system, such as: severe hypertension, coronary atherosclerotic heart disease, diabetes and other basic diseases of instability, hepatitis, tuberculosis patients or blood creatinine, aspertate aminotransferase/cereal third transaminase (AST/ALT) index exceeds the norm for 2 times, blood coagulation tests suggest with bleeding tendency;(8) mental patients;(9) smoking more than 10 cigarettes a day for more than 10 years;(10) if there is a scar at the site of needle application or there is a systemic disease at the site of needle application that the researcher thinks is not suitable for taking measures;(11) the clinical researcher considers that the subject participating in the clinical study cannot cooperate with the treatment;(12) patients participating in other clinical trials;(13) those who have a history of allergic or adverse reactions to drugs and treatment measures related to this experiment. 

研究实施时间:

Study execute time:

From2020-02-20To 2021-01-31 

干预措施:

Interventions:

组别:

西药组

样本量:

61

Group:

The western medicine group

Sample size:

干预措施:

口服氯雷他定片

干预措施代码:

Intervention:

Loratadine tablets are taken orally

Intervention code:

组别:

针刺蝶腭神经节组

样本量:

61

Group:

Acupuncture of sphenopalatine ganglion group

Sample size:

干预措施:

毫针针刺蝶腭神经节

干预措施代码:

Intervention:

The sphenoid palatine ganglion was needled with a needle

Intervention code:

组别:

通窍益肺针灸法组

样本量:

61

Group:

Tongqiao yifei acupuncture group

Sample size:

干预措施:

毫针针刺蝶腭神经节配合艾灸

干预措施代码:

Intervention:

The sphenoid palatine ganglion was needled with a needle and moxibustion was performed

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

秦皇岛市 

Country:

China 

Province:

Hebei 

City:

Qinhuangdao 

单位(医院):

河北省医疗气功医院 

单位级别:

二级医院 

Institution
hospital:

Hebei Medical Qigong Hospital  

Level of the institution:

Level II hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

秦皇岛市 

Country:

China 

Province:

Hebei 

City:

Qinhuangdao 

单位(医院):

秦皇岛市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Qinhuangdao Hospital of traditional Chinese Medicine  

Level of the institution:

Tertiary a hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

秦皇岛市 

Country:

China 

Province:

Hebei 

City:

Qinhuangdao 

单位(医院):

秦皇岛市第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Hospital of Qinhuangdao  

Level of the institution:

Tertiary a hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

指标中文名:

鼻结膜炎相关生活质量问卷

指标类型:

主要指标 

Outcome:

Rhinoconjunctivitis Quality of Life Questionnaire

Type:

Primary indicator 

指标中文名:

患者接受度调查

指标类型:

次要指标 

Outcome:

Patient acceptance survey

Type:

Secondary indicator 

指标中文名:

复发天数调查

指标类型:

次要指标 

Outcome:

Investigation on days of recurrence

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

no

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

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

随机方法(请说明由何人用什么方法产生随机序列):

由统计专业人员采用随机数字表法进行分组

性别:

男女均可

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

Statistical professionnals were grouped using a table of random numbers

Gender:

Both

盲法:

本项目的盲法采用盲法评价,由不知分组情况的第三者进行疗效评价,所有参加评价的人员均接受统一培训,资料总结阶段采用盲法统计分析,统计分析人员不知道分组情况和内容,随机分组者、试验研究者、操作者、统计者三分离, 保证受试者、评估者、统计者不了解分组情况。

Blinding:

Project blinded evaluation by blind method, curative effect evaluation by know grouping of third party, all staff members to participate in evaluation of unified training, data summary stage blind method is used to statistical analysis, statistical analysis personnel don't know the grouping situation and content, randomized, test the researchers, the operator, three separate statistics, maintain the grouping, evaluation, statistics don't understand.

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

通过发表期刊文章公布原始数据

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

by publication

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表采集数据,数据电子存档管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Collect date by CRF and manage date via computer

创建人:

Creater Name:

 2020-02-06
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