芪芍通脉安神方治疗冠心病气虚血瘀证合并焦虑和(或)抑郁的临床研究

注册号:

Registration number:

ITMCTR2200006722

最近更新日期:

Date of Last Refreshed on:

2022-10-31

注册时间:

Date of Registration:

2022-10-31

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

芪芍通脉安神方治疗冠心病气虚血瘀证合并焦虑和(或)抑郁的临床研究

Public title:

Clinical Study of Qi-Shao-Tong-Mai-An-Shen Decoction (QSTMASD) Regimen for Coronary Heart Disease Syndrome of Qi Deficiency and Blood Stasis Patients with Anxiety and/or Depression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中日友好医院心理测评预警系统在患者中西医协作分级管理中的转化研究

Scientific title:

Transformation Research on the Application of Psychological Assessment and Early Warning System in Sino-Japanese Friendship Hospital in the Cooperative Management of Patients with Chinese and Western Medicine

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:

ChiCTR2200065179 ; ChiMCTR2200006722

申请注册联系人:

陈颖

研究负责人:

肖响

Applicant:

chenying

Study leader:

xiaoxiang

申请注册联系人电话:

Applicant telephone:

15652160013

研究负责人电话:

Study leader's telephone:

15810314217

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:

chenying1001@163.com

研究负责人电子邮件:

Study leader's E-mail:

zryhyyxx@163.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:

北京市朝阳区樱花东街2号

研究负责人通讯地址:

北京市朝阳区樱花东街2号

Applicant address:

2 Cherry Blossom East Street, Chaoyang District, Beijing

Study leader's address:

2 Cherry Blossom East Street, Chaoyang 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:

北京中医药大学中日友好临床医学院

Applicant's institution:

Beijing University of Chinese Medicine China-Japan Friendship Clinical Medical College

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:

2022-KY-174-1

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中日友好医院临床研究伦理委员会

Name of the ethic committee:

Clinical Research Ethics Committee of China-Japan Friendship Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

1990/1/1 0:00:00

伦理委员会联系人:

陈燕芬

Contact Name of the ethic committee:

chenyanfen

伦理委员会联系地址:

北京市朝阳区樱花东街2号

Contact Address of the ethic committee:

2 Cherry Blossom East Street, Chaoyang District, Beijing

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:

中日友好医院

Primary sponsor:

China-Japan Friendship Hospital

研究实施负责(组长)单位地址:

北京市朝阳区樱花东街2号

Primary sponsor's address:

2 Cherry Blossom East Street, Chaoyang 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):

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

具体地址:

北京市朝阳区樱花东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 Cherry Blossom East Street, Chaoyang District, Beijing

经费或物资来源:

中央高水平医院临床科研业务费资助,成果转化类项目

Source(s) of funding:

Funded by the Central high-level Hospital clinical research fund, achievement transformation projects

研究疾病:

冠心病合并焦虑和(或)抑郁

研究疾病代码:

Target disease:

Coronary heart disease with anxiety and/or depression

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:

本试验旨在评价QSTMAS中药贴治疗冠心病气虚血瘀证焦虑和/或抑郁患者的疗效。

Objectives of Study:

The purpose of this trial aims to evaluate the curative effect of QSTMAS herbal paste on anxious and/or depressed patients with CHD with qi deficiency and blood stasis syndrome.

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)符合稳定型冠心病西医诊断标准; (2)符合冠心病气虚血瘀证型诊断标准; (3)符合轻微、中度焦虑症和(或)抑郁症诊断标准;(依据中友好医院心理测评预警系统的分级评估结果进行纳入) (4)年龄18-65岁; (5)能接受并配合试验方案及随访者; (6)自愿参加临床研究并签署知情同意书; 以上各项均符合者,纳入本研究。

Inclusion criteria

a)Confirmed to the diagnostic criteria of SCAD; b)Confirmed to TCM syndrome of Qi deficiency and blood stasis; c)Confirmed to the diagnostic criteria of mild and moderate anxiety and/or depression using psychological evaluation scales and the early warning system of China-Japan Friendship Hospital; d)Age 18-65 years old; e)Accept and cooperate with the trial scheme f)Volunteer to participate in this study and sign the informed consent forms. People Who meet the above requirements were included in this study.

排除标准:

(1)正在接受或一月内接受抗焦虑、抑郁药物或其他精神障碍治疗的患者; (2)合并严重心功能不全,如Killp分级II级以上;NYHA分级III级及以上; (3)合并其他严重疾病,如严重的肝肾功能障碍(ALT>正常值3倍,Scr>221μmol/L);严重消耗状态或恶性肿瘤等; (4)妊娠期、哺乳期妇女或有妊娠计划者; (5)对部分中药或中成药可疑或明确过敏; (6)2周内使用与研究所用中药功效类似或相同者; (7)正在参加其它临床研究或一个月内参加过其他中药制剂的临床研究者; 符合以上任意一项,即排除。

Exclusion criteria:

a)Patients who are receiving anxiolytics, antidepressants or drugs for other mental disorders within one month; b)Combined with severe cardiac insufficiency, such as Killip grade II and above; NYHA grade III and above; c)Combined with other serious diseases, such as severe liver and kidney dysfunction (ALT > 3 × upper limits of normal, SCR > 221 μ mol/L); Severe consumption state or malignant tumor; d)Pregnant or lactating women, or those with pregnancy plans; e)Suspicious or definite allergy to Traditional Chinese Medicine or proprietary Chinese medicine; f)Those who use with similar efficacy to the Traditional Chinese Medicine within 2 weeks; g)Those who are participating in other clinical studies now or within one month. If any of the above conditions are met, it will be excluded.

研究实施时间:

Study execute time:

From 2022-11-01

To      2024-08-01

征募观察对象时间:

Recruiting time:

From 2022-11-01

To      2024-05-01

干预措施:

Interventions:

组别:

试验组2

样本量:

66

Group:

Treatment group

Sample size:

干预措施:

冠心病常规西药标准治疗联合芪芍通脉安神方

干预措施代码:

Intervention:

Standard western medicine treatment for CHD as mentioned above combined with QSTMAS Herbal Paste

Intervention code:

组别:

试验组1(对照组)

样本量:

33

Group:

Control group

Sample size:

干预措施:

冠心病常规西药标准治疗药物治疗

干预措施代码:

Intervention:

Standard western medicine treatment for CHD

Intervention code:

样本总量 Total sample size : 99

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):

中日友好医院

单位级别:

三级甲等医院

Institution/hospital:

China-Japan Friendship Hospital

Level of the institution:

A tertiary hospital

测量指标:

Outcomes:

指标中文名:

焦虑(GAD-7)、抑郁(PHQ-9)量表评分

指标类型:

主要指标

Outcome:

GAD-7 and PHQ-9 scale scores

Type:

Primary 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:

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 65
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):

使用spss26.0中的随机数生成器,生成了99例患者对应的随机数。 采用随机病例样本函数,将99例患者按1:2的比例随机分为对照组和治疗组。

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

Using the random number generator in spss26.0, the corresponding random numbers of 99 patients are generated. Using the random case sample function, 99 patients are randomly divided into control group and treatment group in the ratio of 1:2. Control group is recorded as 1 and the treatment group is reco

盲法:

本研究采用单盲方法,即盲终点法。 只有结果评估者是盲目的。 结果评估人员和数据分析师是第三方人员,他们不知道受试者的分组和干预措施的分配。

Blinding:

In this study, a single blind method, namely blind endpoint method, was used. Only the outcome evaluator is blind. Results evaluators and data analysts are third-party personnel who do not know the grouping of subjects and the allocation of intervention measures.

是否共享原始数据:

IPD sharing:

No

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):

不共享原始数据

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

no sharing

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:

研究人员将对患者进行随访,直到试验结束,所有一般数据和结果评价将在每次研究访问时记录在病例报告表中。 研究人员还将使用SPSS 26.0更新电子数据库。

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

Patients will be followed up by a study investigator until the end of the trial, and all general data and outcome evaluations will be recorded in the case report form at each study visit. Investigators will also update an electronic database using SPSS 26.0.

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):

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