Clinical study of acupoint catgut embedding for the treatment of postinfectious cough

注册号:

Registration number:

ITMCTR2024000299

最近更新日期:

Date of Last Refreshed on:

2024-08-26

注册时间:

Date of Registration:

2024-08-26

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

穴位埋线治疗感染后咳嗽的临床研究

Public title:

Clinical study of acupoint catgut embedding for the treatment of postinfectious cough

注册题目简写:

English Acronym:

研究课题的正式科学名称:

穴位埋线治疗感染后咳嗽的临床研究

Scientific title:

Clinical study of acupoint catgut embedding for the treatment of postinfectious cough

研究课题的正式科学名称简写:

Scientific title acronym:

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:

郗亚薇

研究负责人:

李彬

Applicant:

XI Yawei

Study leader:

LI Bin

申请注册联系人电话:

Applicant telephone:

18601144700

研究负责人电话:

Study leader's telephone:

010-52176644

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:

yyaawweeii@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

libin@bjzhongyi.com

申请单位网址(自愿提供):

Study leader's 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:

北京市房山区良乡拱辰大街45号

研究负责人通讯地址:

北京市东城区美术馆后街23号

Applicant address:

45 Gongchen Street, Liangxiang, Fangshan District, Beijing

Study leader's address:

No. 23, Museum Back Street, Dongcheng District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100010

研究负责人邮政编码:

Study leader's postcode:

100010

申请人所在单位:

北京市房山区良乡医院

Applicant's institution:

Liangxiang Hospital of Beijing Fangshan District

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

京良伦批第(2024005)号

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京市房山区良乡医院伦理委员会

Name of the ethic committee:

Ethics Committee of Liangxiang Hospital Fangshan District Beijing

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/24 0:00:00

伦理委员会联系人:

安晓洁

Contact Name of the ethic committee:

An Xiaojie

伦理委员会联系地址:

北京市房山区良乡拱辰大街45号

Contact Address of the ethic committee:

45 Gongchen Street, Liangxiang, Fangshan District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

81356258

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lxyykyb@163.com

研究实施负责(组长)单位:

首都医科大学附属北京中医医院

Primary sponsor:

Beijing Hospital of TCM Affiliated to Capital Medical University

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号

Primary sponsor's address:

No. 23, Museum Back Street, 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

市(区县):

房山区

Country:

China

Province:

Beijing

City:

Fangshan District

单位(医院):

北京市房山区良乡医院

具体地址:

北京市房山区良乡拱辰大街45号

Institution
hospital:

Liangxiang Hospital of Beijing Fangshan District

Address:

45 Gongchen Street, Liangxiang, Fangshan District, Beijing

经费或物资来源:

自筹

Source(s) of funding:

self-financing

研究疾病:

感染后咳嗽

研究疾病代码:

Target disease:

postinfectious cough

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

评价穴位埋线治疗感染后咳嗽的疗效及安全性

Objectives of Study:

To evaluate the efficacy and safety of acupoint catgut embedding in the treatment of postinfectious cough

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合感染后咳嗽的西医诊断标准; (2)年龄为18—70岁,男女不限; (3)受试者知情并签署知情同意书; (4)从未接受过穴位埋线治疗者

Inclusion criteria

(1) Meet the Western medical diagnostic criteria for cough after infection; (2) Age 18-70 years old, male or female; (3) The subject knows and signs the informed consent; (4) Those who have never received acupoint catgut embedding treatment

排除标准:

(1)体温(腋温)≥37.0℃者; (2)已知或疑似与咳嗽诊断相关的疾病,如过敏性鼻炎、鼻窦炎、胃食管反流病、咳嗽变异性哮喘、嗜酸粒细胞性支气管炎、慢性阻塞性肺疾病、慢性支气管炎急性发作、支气管哮喘、支气管扩张、肺结核、肺间质纤维化、肺癌等; (3)合并有心脑血管、肝、肾和造血系统等严重原发性疾病及肿瘤等其他器质性病变等; (4)合并有语言或听力障碍、智力障碍、严重精神疾患等不能配合的情况者; (5)孕妇及哺乳期妇女、近半年有生育要求者; (6)进行与咳嗽有关的常规治疗(如血管紧张素转换酶抑制剂); (7)正在参加其他临床试验者。

Exclusion criteria:

(1) Body temperature (axillary temperature) ≥37.0℃; (2) Known or suspected diseases associated with the diagnosis of cough, such as allergic rhinitis, sinusitis, gastroesophageal reflux disease, cough variant asthma, eosinophilic bronchitis, chronic obstructive pulmonary disease, acute onset of chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis, pulmonary interstitial fibrosis, lung cancer, etc.; (3) Complicated with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other organic diseases such as tumors; (4) the combination of language or hearing impairment, intellectual disability, serious mental illness and other conditions can not cooperate; (5) Pregnant and lactating women, those who have fertility requirements in the past six months; (6) Regular cough related treatment (such as angiotensin-converting enzyme inhibitors); (7) Those who are participating in other clinical trials.

研究实施时间:

Study execute time:

From 2024-04-01

To      2026-06-30

征募观察对象时间:

Recruiting time:

From 2024-08-30

To      2026-06-30

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

treatment group

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

acupoint catgut embedding

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

非穴浅刺

干预措施代码:

Intervention:

Non-point shallow thorn

Intervention code:

样本总量 Total sample size : 100

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):

东城区

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京中医医院

单位级别:

三级甲等

Institution/hospital:

Beijing Hospital of TCM Affiliated to Capital Medical University

Level of the institution:

Class A hospital

国家:

中国

省(直辖市):

北京市

市(区县):

房山区

Country:

China

Province:

Beijing

City:

Fangshan District

单位(医院):

北京市房山区良乡医院

单位级别:

三级

Institution/hospital:

Liangxiang Hospital of Beijing Fangshan District

Level of the institution:

tertiary hospitals

测量指标:

Outcomes:

指标中文名:

简易咳嗽程度评分表

指标类型:

次要指标

Outcome:

cough evaluation test(CET)

Type:

Secondary indicator

测量时间点:

基线和2周、4周的时间点

测量方法:

评分

Measure time point of outcome:

Baseline and 2 - and 4-week time points

Measure method:

score

指标中文名:

莱切斯特咳嗽生命质量问卷

指标类型:

主要指标

Outcome:

LCQ

Type:

Primary indicator

测量时间点:

基线和2周、4周的时间点

测量方法:

问卷评分

Measure time point of outcome:

Baseline and 2 - and 4-week time points

Measure method:

Questionnaire score

指标中文名:

咳嗽缓解时间和消失时间

指标类型:

次要指标

Outcome:

Cough remission time and resolution time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽视觉模拟评分

指标类型:

次要指标

Outcome:

vas

Type:

Secondary indicator

测量时间点:

基线和2周、4周的时间点

测量方法:

自我评分

Measure time point of outcome:

Baseline and 2 - and 4-week time points

Measure method:

self-rating

指标中文名:

中医症状积分

指标类型:

次要指标

Outcome:

TCM symptom score

Type:

Secondary indicator

测量时间点:

基线和2周、4周的时间点

测量方法:

评分

Measure time point of outcome:

Baseline and 2 - and 4-week time points

Measure method:

score

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由专人制作随机信封以实现隐蔽分组。随机信封要求不透明,信封外标明入组序号,信封内为分组信息,要求研究者按照患者入组顺序拆开信封,根据分组信息对入组患者实施干预。

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

Random envelopes are made by a special person to achieve hidden grouping. The random envelopes were required to be opaque, the enrollment number was marked on the outside of the envelope, and the grouping information was displayed inside the envelope. The researchers were required to open the envelopes according to the order in which patients were enrolled, and to intervene the enrolled patients according to the grouping information.

盲法:

单盲,盲患者,针灸医师不设盲。在疗效评价阶段采用盲法评价,由不知分组情况的专人进行疗效评价,在资料总结阶段采用盲法统计分析,实行研究者、评价者、统计者三分离。由于干预的性质,针灸师不设能盲,但他们将接受培训,不与参与者或结果评估者就治疗程序和反应进行沟通。

Blinding:

Single blind, blind patients, acupuncturists do not set blindness. In the therapeutic effect evaluation stage, the blind evaluation was carried out by a person who did not know the group status. In the data summary stage, the blind statistical analysis was carried out, and the three separations of researchers, evaluators and statisticians were implemented.Because of the nature of the intervention, acupuncturists cannot be blinded, but they will be trained not to communicate with participants or outcome assessors about treatment procedures and responses.

是否共享原始数据:

IPD sharing:

Yes

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):

2027年1月上传到ResMan临床试验公共管理平台 Clinical Trial Management Public Platform

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

Uploaded to ResMan Clinical Trial Management Public Platform

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:

按照GCP的有关标准,制作临床病例观察表,减少了观察评价过程中的测量性偏倚;对每个纳入患者都详细记录地址和电话,通过电话预约等方式保证了临床研究资料的完整性;根据CRF表,完整记录诊疗信息,对临床采集的信息进行数据核查,保证了统计数据的准确性。受试者的个人资料均属保密,可以识别受试者身份的信息将不会透露给研究小组以外的成员,除非获得受试者的许可,所有的研究成员都被要求对受试者的身份保密。受试者的档案将保存在有锁的档案柜中,仅供研究人员查阅。为确保研究按照规定进行,必要时,政府管理部门或伦理委员会的成员按规定可以在研究单位查阅受试者的个人资料。这项研究结果发表时,将不会披露受试者个人的任何资料。

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

According to the relevant standards of GCP, the clinical case observation table was made to reduce the measurement bias in the process of observation and evaluation. The address and telephone number of each enrolled patient were recorded in detail, and the integrity of clinical research data was ensured by telephone reservation. According to the CRF table, the diagnosis and treatment information was recorded completely, and the data of the clinical information was checked to ensure the accuracy of the statistical data. Personal data of the subject will be kept confidential. Information that can identify the subject will not be disclosed to members outside the research team, and all research members are required to keep the subject's identity confidential unless they have obtained the subject's permission. Subjects' files will be kept in a locked filing cabinet and will be accessible only to researchers. In order to ensure that the study is conducted in accordance with the regulations, the members of the government administration or ethics committee may, as required, access the subject's personal data at the research facility. When the results of this study are published, no information about the individual subjects will be disclosed.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above