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补肾益气方减轻缓解期哮喘患者道高反应及气道炎症的临床研究
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注册号:

Registration number:

ChiCTR1900021907 

最近更新日期:

Date of Last Refreshed on:

2019-03-15 

注册时间:

Date of Registration:

2019-03-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

补肾益气方减轻缓解期哮喘患者道高反应及气道炎症的临床研究 

Public title:

A randomized controllde study for Bu-Shen-Yi-Qi Decoction in relieving airway hyperresponsiveness and airway inflammation in asthma patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

补肾益气方减轻缓解期哮喘患者道高反应及气道炎症的临床研究 

Scientific title:

Integrative Chinese and Western Medicine 

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:

马骋 

研究负责人:

苏明跃 

Applicant:

Ma Cheng 

Study leader:

Su Mingyue 

申请注册联系人电话:

Applicant telephone:

+86 02152888301 

研究负责人电话:

Study leader's telephone:

+86 15912968655 

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:

cheng_ma13@126.com 

研究负责人电子邮件:

Study leader's E-mail:

47921993@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:

上海市静安区乌鲁木齐中路12号 

研究负责人通讯地址:

普洱市思茅区茶城大道13号 

Applicant address:

12 Middle Urumqi Road, Jing‘an District, Shanghai, China 

Study leader's address:

13 Chacheng Avenue, Simao District, Pu’er, Yunnan, 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:

复旦大学附属华山医院 

Applicant's institution:

Huashan Hospital, Fudan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

普洱市中医医院 

Primary sponsor:

Pu’er Hospital of traditional Chinese Medicine 

研究实施负责(组长)单位地址:

普洱市思茅区茶城大道13号 

Primary sponsor's address:

13 Chacheng Avenue, Simao District, Pu‘er, Yunnan, 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):

云南

市(区县):

普洱

Country:

China

Province:

Yunnan

City:

Pu'er

单位(医院):

普洱市中医医院

具体地址:

思茅区茶城大道13号

Institution
hospital:

Pu‘er Hospital of traditional Chinese Medicine

Address:

13 Chacheng Avenue, Simao District

经费或物资来源:

自筹经费、银行贷款、市科技经费 

Source(s) of funding:

self-financing、bank loan、municipal science and technology expenditure 

研究疾病:

支气管哮喘 

Target disease:

bronchial asthma 

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:

探索性研究/预试验 

Study phase:

研究目的:

1. 通过开展多中心、随机、双盲临床研究评价补肾益气方治疗缓解期哮喘患者气道高反应及气道炎症、减少急性加重发作次数的有效性和安全性,获取高价值的临床证据。 2. 按照补肾益气方药干预支气管哮喘临床研究方案,以技术成果在普洱转化应用为阶段目标。门诊人次及出院人次逐年上升3%。 

Objectives of Study:

1. A multi-center, randomized, double-blind clinical study was conducted to evaluate the effectiveness and safety of bushenyiqi prescription in the treatment of airway hyperresponsiveness and airway inflammation in patients with remission phase asthma, and to reduce the number of acute exacerbations, so as to obtain high-value clinical evidence. 2. According to the clinical research program of treating bronchial asthma with prescription of tonifying kidney and invigorating qi, the objective is to transform and apply the technical achievements in pu 'er.Outpatient visits and discharge visits increased by 3% year by year. 

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) 入选时年龄18-75 岁,性别不限; (2) 现代医学诊断为支气管哮喘,其急性发作后症状缓解、体征消失,到达发作前水平的患者; (3) 过去两年急性加重次数平均每年≥2次; (4) 中医辨证肺肾气虚为主; (5) 受试者自愿参加研究并已签署知情同意书。 

Inclusion criteria

(1) Aged 18-75 years at the time of selection, regardless of gender; (2) Patients diagnosed as bronchial asthma by modern medicine, whose symptoms relieve and signs disappear after acute attack and reach the pre-attack level; (3) The average number of acute exacerbations in the past two years was more than 2 times per year; (4) TCM syndrome differentiation of lung and kidney qi deficiency; (5) Subjects will participate in the study voluntarily and have signed the informed consent. 

排除标准:

(1) 合并支气管扩张、活动性肺结核、肺部感染、肺间质纤维化、气胸、胸腔积液、肺栓塞、影响呼吸运动功能的神经肌肉疾病者; (2) 需要长期口服糖皮质激素或者长期使用指南推荐的控制哮喘药物超过3种以上的患者; (3) 已怀孕或计划怀孕、哺乳期妇女; (4) 恶性肿瘤及血液病患者; (5) 3个月内参加过其它药品临床试验者; (6) 心、肝、肾功能严重损害者(心功能3~4级,ALT和/或AST超过正常上限1.5倍以上,Cr 超过正常上限); (7) 患有风湿免疫性疾病、肾上腺皮质功能减退,需使用激素、免疫抑制剂的患者; (8) 中医辨为阴虚火旺证的患者; (9) 研究者认为不适合入组的其它情况。 

Exclusion criteria:

(1) Patients with bronchiectasis, active pulmonary tuberculosis, pulmonary infection, pulmonary interstitial fibrosis, pneumothorax, pleural effusion, pulmonary embolism, or neuromuscular diseases affecting respiratory motor function; (2) Patients who need long-term oral glucocorticoid or more than 3 kinds of asthma control drugs recommended by the long-term use guidelines; (3) Women who are pregnant or plan to become pregnant or lactating; (4) Patients with malignant tumors and blood diseases; (5) Have participated in the clinical trials of other drugs within 3 months; (6) Patients with severe cardiac, liver and renal function impairment (cardiac function level 3 ~ 4, ALT and/or AST exceeding 1.5 times of the normal upper limit, Cr exceeding the normal upper limit); (7) Patients suffering from rheumatic immune diseases and adrenal cortical dysfunction who need hormone and immunosuppressant; (8) Patients with fire flourishing syndrome of Yin deficiency identified by TCM; (9) Other conditions considered by the researcher not suitable for enrollment. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-10-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

50

Group:

treatment group

Sample size:

干预措施:

吸入性糖皮质激素联合长效β2受体激动剂+补肾益气方

干预措施代码:

Intervention:

ICS/LABA+Yi-Qi DecoctionBu-Shen-

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

吸入性糖皮质激素联合长效β2受体激动剂+补肾益气方模拟剂

干预措施代码:

Intervention:

ICS/LABA+mimetic Bu-Shen-Yi-Qi Decoction

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

云南 

市(区县):

普洱 

Country:

China 

Province:

Yunnan 

City:

Pu'er 

单位(医院):

普洱市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Puer Hospital of traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华山医院 

单位级别:

三级甲等 

Institution
hospital:

Huashan Hospital, Fudan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

急性加重次数

指标类型:

主要指标 

Outcome:

Frequency of acute exacerbations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发作时间及程度

指标类型:

主要指标 

Outcome:

Duration and degree of attack

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼气峰流速值

指标类型:

主要指标 

Outcome:

peak expiratory flow (PEF)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均每日昼夜变异率

指标类型:

主要指标 

Outcome:

the average daily diurnal variation rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼出气一氧化氮

指标类型:

主要指标 

Outcome:

Fractional exhaled nitric oxide (FENO)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ACT评分

指标类型:

次要指标 

Outcome:

ACT 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:

中医证候量化评分

指标类型:

次要指标 

Outcome:

Quantitative scoring of TCM syndromes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血炎症指标

指标类型:

次要指标 

Outcome:

Peripheral blood inflammatory markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

诱导痰中炎症指标

指标类型:

次要指标 

Outcome:

Inflammatory markers in induced sputum

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆HPA轴相关标记物

指标类型:

次要指标 

Outcome:

HPA axis related markers in plasma

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

唾液HPA轴相关标记物

指标类型:

次要指标 

Outcome:

HPA axis related markers in saliva

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:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

唾液

组织:

Sample Name:

Saliva

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

诱导痰

组织:

Sample Name:

Induced S\putum

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

采用简单随机化分组方法,由研究负责人采用随机数字表的方法产生随机序列号。

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

A simple randomized grouping method will be used, and the random sequence Numbers are generated by the random number table method.

盲法:

双盲

Blinding:

Double-blind

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):

由项目主要实施单位建立共享平台,统一共享数据

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

The main implementing units of the project shall establish a sharing platform to share data uniformly

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:

所有资料按照GCP要求保存,试验完成后,全部病例报告表原件、临床药品使用记录表经研究负责人按本方案数据管理的要求填写、审核和签字,交负责单位。负责单位负责建立数据库,统一进行数据处理,由统计人员对全部资料进行统计,主要研究者负责完成临床试验总结报告。相关资料至少保存5年。

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

All data shall be kept in accordance with the requirements of GCP. After the completion of the test, all original case report forms and clinical drug use records shall be filled in, reviewed and signed by the person in charge of the study according to the requirements of data management of this program and submitted to the responsible unit.The responsible unit is responsible for establishing the database, conducting unified data processing, and the statisticians are responsible for the statistics of all the data, and the main researchers are responsible for completing the summary report of clinical trials.Relevant data shall be kept for at least 5 years.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-15
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