预针刺蝶腭神经节对季节性变应性鼻炎患者鼻腔功能的影响

注册号:

Registration number:

AMCTR-IPR-20000317 

注册号获得时间:

Date of releasing the registration number:

2020/1/2 1:24:03 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

预针刺蝶腭神经节对季节性变应性鼻炎患者鼻腔功能的影响 

Public title:

Effect of preacupuncture to sphenopalatine ganglion on nasal function in patients with seasonal allergic rhinitis 

研究课题的正式科学名称:

预针刺蝶腭神经节对季节性变应性鼻炎患者鼻腔功能的影响 

Scientific title:

Effect of preacupuncture to sphenopalatine ganglion on nasal function in patients with seasonal allergic rhinitis 

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:

张鹏 

研究负责人:

陈陆泉 

Applicant:

Peng Zhang 

Study leader:

Lu-quan Chen 

申请注册联系人电话:

Applicant telephone:

13811674084 

研究负责人电话:

Study leader's telephone:

50268094 

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:

ellen0326@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chenluquan@hotmail.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:

北京市东城区东交民巷1号 

研究负责人通讯地址:

北京市东城区东交民巷1号 

Applicant address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

Study leader's address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

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:

首都医科大学附属北京同仁医院针灸科 

Applicant's institution:

Department of Acupuncture-Moxibustion,Beijing Tongren Hospital Affiliated to Capital Medical University 

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:

tr20180313 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tongren Hospital affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-13 

研究实施负责(组长)单位:

首都医科大学附属北京同仁医院针灸科 

Primary sponsor:

Department of Acupuncture-Moxibustion,Beijing Tongren Hospital Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区东交民巷1号 

Primary sponsor's address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区东交民巷1号

Institution
hospital:

Beijing Tongren Hospital Affiliated to Capital Medical University

Address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing

经费或物资来源:

李新吾名老中医工作室 

Source(s) of funding:

Li Xinwu's Chinese Medicine Studio 

研究疾病:

季节性过敏性鼻炎 

Target disease:

Seasonal 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:

团队前期研究已明确了蝶腭神经节针刺法对于中重度变应性鼻炎临床症状改善、生活质量提高、卫生经济学效率方面优于常规针刺组;在随后的回顾性研究中发现不同体质类型鼻炎患者针刺蝶腭神经节疗效存在差异;在作用机理研究发面目前发现针刺蝶腭神经节能够改善交感神经与副交感神经功能失衡状态,调节相关神经递质和细胞因子的作用。本课题研究在前期研究基础上,比较预先针刺与常规针刺蝶腭神经节对季节性变应性鼻炎患者鼻腔功能的影响及对鼻炎患者主观治疗效果的差异,以确定针刺介入时点是否是影响疗效的因素,作为蝶腭神经节针刺法系统化研究的一部分。 

Objectives of Study:

The early study has made clear that acupuncture ganglionic ganglion is superior to meridian points about the clinical symptoms, the quality of life and the efficiency economics of the patients with moderate to severe allergic rhinitis. In the subsequent retrospective study, there was a difference in the effect of needling in the sphenoidal ganglion of the patients with different constitutional types of rhinitis, in addition,the study of the mechanism was found that the acupuncture in ganglion can improve the imbalance between the sympathetic and parasympathetic functions, Regulating the effects of related neurotransmitters and cytokines. on the basis of the earlier study,this research will compare the nasal function and subjective treatment effect of seasonal allergic rhinitis patients of pre-acupuncture with timely acupuncture in the sphenoidal ganglion,to determine whether the timepoint is one of factors that affecting the curative effect. this study is a part of the systematic study about sphenoidal ganglion needling. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1) 符合季节性变应性鼻炎诊断标准; 2) 年龄在18-65岁之间; 3) 至少连续两年在同一季节发病, 且发病期与致敏花粉传粉期相近; 4) 发作期症状符合鼻痒、喷嚏、鼻分泌物和鼻塞4项症状中至少3项 5) 符合鼻黏膜苍白、水肿或充血、肿胀的鼻镜特征表现,伴或不伴结膜充血、水肿,肿胀的临床表现; 6) 自愿签署知情同意书; 7) 入组前至少一周未接受过其它抗过敏治疗。 

Inclusion criteria

1) Accord with the diagnosis of seasonal allergic rhinitis, 2) Age between 18 to 65 years old, 3) At least two years in the same season break out, pollen transmission at the same time, 4) The symptoms were in accordance with nasal itching, sneezing, nasal secretions and nasal congestion. 5) Nasal mucosa pale, edema or hyperemia, swelling nasal mirror, with or without conjunctival congestion, edema and swelling, 6) Voluntarily sign informed consent, 7) No other antiallergic treatment was received at least one week before entering the group. 

排除标准:

1) 体温异常者; 2) 有晕针史者; 3) 鼻腔结构畸形; 4) 针刺路径周围组织解剖结构异常; 5) 针刺局部感染或存在其他针刺可能诱发颅内感染风险者; 6) 长期服用鼻炎相关治疗药物; 7) 合并有心脑血管、肝、肾和凝血功能异常者; 8) 精神病患者。 

Exclusion criteria:

1) Patients with abnormal body temperature; 2) Patients with history of halo acupuncture; 3) Structural deformity of nasal cavity; 4) Abnormal anatomical structure around acupuncture pathway; 5) Patients with local infection or other acupuncture may induce intracranial infection; 6) Taking rhinitis related drugs for a long time; 7) Patients with abnormal cardiovascular and cerebrovascular, liver, kidney and coagulation functions; 8) Psychotic patients. 

研究实施时间:

Study execute time:

From2019-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

预针刺组

样本量:

60

Group:

pro-acupucture group

Sample size:

干预措施:

发作期前2周针刺蝶腭神经节

干预措施代码:

Intervention:

Acupuncture of sphenopalatine ganglion 2 weeks before attack

Intervention code:

组别:

针刺组

样本量:

60

Group:

acupucture group

Sample size:

干预措施:

发作后针刺蝶腭神经节

干预措施代码:

Intervention:

Acupuncture of sphenopalatine ganglion after attack

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三甲 

Institution
hospital:

Beijing Tongren Hospital Affiliated to Capital Medical University  

Level of the institution:

3A 

测量指标:

Outcomes:

指标中文名:

鼻炎症状量表评分

指标类型:

主要指标 

Outcome:

TNSS

Type:

Primary indicator 

指标中文名:

鼻炎伴随症状量表评分

指标类型:

主要指标 

Outcome:

TNNSS

Type:

Primary indicator 

指标中文名:

鼻声反射

指标类型:

主要指标 

Outcome:

Nasal acoustic reflex

Type:

Primary indicator 

指标中文名:

鼻阻力

指标类型:

主要指标 

Outcome:

nasal airway resistance

Type:

Primary indicator 

指标中文名:

血管紧张素

指标类型:

主要指标 

Outcome:

VIP

Type:

Primary indicator 

指标中文名:

血管紧张素

指标类型:

次要指标 

Outcome:

VIP

Type:

Secondary indicator 

指标中文名:

神经肽Y

指标类型:

次要指标 

Outcome:

NPY

Type:

Secondary indicator 

指标中文名:

组胺类物质

指标类型:

次要指标 

Outcome:

HIS

Type:

Secondary indicator 

指标中文名:

神经生长因子

指标类型:

次要指标 

Outcome:

NGF

Type:

Secondary indicator 

指标中文名:

P物质

指标类型:

次要指标 

Outcome:

Sunstance P

Type:

Secondary indicator 

指标中文名:

最小鼻横截面积

指标类型:

次要指标 

Outcome:

nasal cross sectional area,NC

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

鼻分泌物

组织:

Sample Name:

Nasal discharge

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 65 years

随机方法(请说明由何人用什么方法产生随机序列):

由不参与患者入组的独立工作人员采用SAS统计软件PROCPLAN过程语句产生随机机序列

性别:

男女均可

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

The independent staff enrolled in the non-participating patient developed a random random sequence using the SAS statistical software PROCPLAN procedure statement

Gender:

Both

盲法:

Blinding:

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):

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

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):

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

创建人:

Creater Name:

 2019-11-22
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