中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300079225
最近更新日期： Date of Last Refreshed on：	2023-12-27 16:41:26
注册时间： Date of Registration：	2023-12-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	“畅络调神”思想防治冠心病合并焦虑症的理论及临床研究
Public title：	Theoretical and clinical research on the treatment of coronary heart disease complicated with anxiety disorder based on the thought of "Chang Luo Tiao Shen"
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于“畅络调神”思想治疗冠心病合并焦虑症的理论与临床研究
Scientific title：	Theoretical and clinical research on the treatment of coronary heart disease complicated with anxiety disorderbased on the thought of "Chang Luo Tiao Shen"
研究课题代号(代码)： Study subject ID：	L2023-ZDYF-SF-047
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：	宁博	研究负责人：	赵明君
Applicant：	Ning Bo	Study leader：	Zhao Mingjun
申请注册联系人电话： Applicant telephone：	+86 183 9107 8722	研究负责人电话： Study leader's telephone：	+86 135 7279 9533
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：	ningbo9803@163.com	研究负责人电子邮件： Study leader's E-mail：	zmj7125@163.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：	陕西省咸阳市秦都区渭阳西路街道沈兴北路建花苑小区4-1-1-东	研究负责人通讯地址：	陕西省咸阳市秦都区渭阳西路街道陕中大附院
Applicant address：	4-1-1-East, Jianhuayuan Community, Shenxing North Road, Weiyang West Road Street, Qindu District, Xianyang City, Shaanxi Province	Study leader's address：	Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang West Road Street, Qindu District, Xianyang City, Shaanxi Province
申请注册联系人邮政编码： Applicant postcode：	712046	研究负责人邮政编码： Study leader's postcode：	712046
申请人所在单位：	陕西中医药大学
Applicant's institution：	Shaanxi University of Chinese Medicine
研究负责人所在单位：	陕西中医药大学附属医院
Affiliation of the Leader：	Affiliated Hospital of Shaanxi University of Chinese Medicine

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：	SZFYIEC-PJ-2023 年第[13]号	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：	陕西中医药大学附属医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Affiliated Hospital of Shaanxi University of Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2023-03-23 00:00:00
伦理委员会联系人：	钟慧慧
Contact Name of the ethic committee：	Zhong Huihui
伦理委员会联系地址：	陕西省咸阳市秦都区渭阳西路街道陕中大附院医师培训楼
Contact Address of the ethic committee：	Doctor Training Building, Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang West Road Street, Qindu District, Xianyang City, Shaanxi Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 29 3337 7941	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：

陕西中医药大学附属医院

Primary sponsor：

Affiliated Hospital of Shaanxi University of Chinese Medicine

研究实施负责（组长）单位地址：

陕西省咸阳市秦都区渭阳西路街道陕中大附院

Primary sponsor's address：

Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang West Road Street, Qindu District, Xianyang City, Shaanxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	陕西省	市(区县)：	咸阳市
Country：	China	Province：	Shaanxi Province	City：	Xianyang City
单位(医院)：	陕西中医药大学附属医院	具体地址：	陕西省咸阳市秦都区渭阳西路街道陕中大附院
Institution hospital：	Affiliated Hospital of Shaanxi University of Chinese Medicine	Address：	Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang West Road Street, Qindu District, Xianyang City, Shaanxi Province

经费或物资来源：

咸阳市科技局

Source(s) of funding：

Science and Technology Bureau of Xianyang City

研究疾病：

冠心病

Target disease：

Coronary heart disease

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：

0

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

基于前期理论基础及临床验案归纳整理陕西省名中医赵明君主任医师治疗双心疾病的学术思想--“畅络调神”思想，证实“畅络调神”思想指导下的畅络调肝定魂方治疗CHD合并焦虑症（络气郁滞型）的有效性及安全性，验证其从“络”“神”角度治疗的可行性，进而为从“畅络调神”思想角度治疗双心疾病提供循证医学证据。

Objectives of Study：

Based on the previous theoretical basis and clinical cases, this paper summarizes the academic thought of chief physician Zhao Mingjun of Shaanxi Province in the treatment of double heart disease - "Changluo Tiaogandingsoul" thought, confirms the efficacy and safety of Changluo Tiaogandingsoul recipe under the guidance of "Changluo Tiaoshen" thought in the treatment of CHD complicated with anxiety disorder (collateral-qi stagnation type), and verifices the feasibility of its treatment from the perspective of "collateral-qi" and "spirit". Thus, it provides evidence-based medical evidence for the treatment of double heart diseases from the perspective of "unblocking collaterals and regulating the spirit".

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

(1) Patients with grade I to II angina pectoris who meet the diagnostic criteria for stable angina pectoris of CHD in western medicine and have at least 3 episodes of angina pectoris per week:
(2) Electrocardiogram examination has one of the following: positive exercise test electrocardiogram: negative ordinary electrocardiogram, but the subject has a clear history of previous myocardial infarction, or coronary artery disease confirmed by coronary angiography (50% stenosis of any vessel) or myocardial radionuclide imaging: electrocardiogram can have obvious ischemic changes during angina attack:
(3) patients with mild to moderate anxiety who met the diagnostic criteria of anxiety and scored between 14 and 29
(4) Conforming to the diagnostic criteria of chest stuffiness, pain and depression in traditional Chinese medicine:
(5) Conforming to the syndrome differentiation criteria of collateral-qi stagnation syndrome type:
(6) Stable vital signs and certain expressive ability:
(7) 30 years old ≤ age ≤75 years old, male or female:
(8) Those who have not taken other anti-anxiety drugs within 2 weeks:
(9) patients who signed the informed consent form.
Patients who met all nine of these criteria were eligible for the study.

排除标准：

(1)经检查证实为急性心肌梗死、不稳定型心绞痛以及其他心脏疾患、甲亢、胆心病、更年期症候群、胃及食管反流、神经官能症等所致胸痛者:(2)合并未控制的III级高血压(收缩压180m 和/或舒张压2110mHg)，重度心肺功能不全，严重的心律失常，或影响其生存的严重疾病(如肿瘤等)及精神病患者:(3) 合并其它可能导致出血风险增加的临床情况，如近半年重要脏器出血史(如脑出血、上消化道出血等)、凝血功能异常、近期有活动性出血等:(4)肝肾功能不全严重的患者，有进行性发展性疾病或者预后很差的疾病如严重感染、严重水电解质紊乱、酸碱平衡失调患者: (5)心功能IV 级的患者: (6)严重的焦虑且需口服抗焦虑西药治疗，HAMA 评分29 分者: (7) 妊娠、哺乳期妇女: (8)易药物过敏者: (9)研究者认为不适合参加临床试验者。具备以上任何一项者不能纳入本次研究。

Exclusion criteria：

(1) Chest pain caused by acute myocardial infarction, unstable angina, other heart diseases, hyperthyroidism, biliary heart disease, climacteric syndrome, gastric and esophageal reflux, neurosis, etc. :(2) with uncontrolled grade III hypertension (systolic blood pressure 180m and/or diastolic blood pressure 2110mHg), severe cardiopulmonary dysfunction; (3) patients with other clinical conditions that may increase the risk of bleeding, such as the history of bleeding in important organs (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), abnormal coagulation function, and recent active bleeding, etc. (4) patients with severe liver and kidney insufficiency; Patients with progressive developmental diseases or diseases with very poor prognosis such as severe infections, severe water and electrolyte disorders, acid-base disorders: (5) Patients with cardiac function class IV: (6) Severe anxiety requiring oral anti-anxiety medication, HAMA score 29: (7) Pregnant and lactating women: (8) Susceptible to drug allergy: (9) those who were deemed unsuitable for clinical trial participation by the investigators. Patients with any of the above criteria were excluded from the study.

研究实施时间：

Study execute time：

从 From 2023-12-31 00:00:00至 To 2024-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-01-01 00:00:00 至 To 2024-05-31 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	30
Group：	Control group	Sample size：	30
干预措施：	对照组采用基础治疗：改善预后药物，改善症状药物以及其他如代谢性药物	干预措施代码：
Intervention：	The control group received basic treatment: Drugs to improve prognosis, drugs to improve symptoms and other metabolic drugs.	Intervention code：

组别：	试验组	样本量：	30
Group：	Experimental Group	Sample size：	30
干预措施：	试验组采用：基础治疗+畅络调肝定魂汤	干预措施代码：
Intervention：	The experimental group used: Basic treatment + Changluo Tiaogan Dingsoul decoction	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	陕西省	市(区县)：	咸阳市
Country：	China	Province：	Shaanxi Province	City：	Xianyang City
单位(医院)：	陕西中医药大学附属医院	单位级别：	三甲
Institution hospital：	Affiliated Hospital of Shaanxi University of Chinese Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	西雅图心绞痛量表评分	指标类型：	主要指标
Outcome：	Seattle Angina Scale score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	汉密尔顿焦虑量表评分	指标类型：	主要指标
Outcome：	Hamilton Anxiety Scale score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	心电图	指标类型：	次要指标
Outcome：	Electrocardiogram	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中医证候积分	指标类型：	次要指标
Outcome：	TCM syndrome score	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：	尿液	组织：
Sample Name：	Urine	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	30	岁 years
最大 Max age	75	岁 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）：

按照入组顺序由研究者将患者编号成 1-60 数字序列，将所生成数字序列录入SPSS22.0 中随机生成 1-60 数列，随机个案样本，将入组数列转换成0、1 两个编号，“0”纳入对照组，“1”纳入试验组。

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

According to the enrollment order, the patients were numbered into a 1-60 number sequence by the researcher, and the generated number sequence was input into SPSS22.0 to generate a 1-60 number sequence randomly. The enrollment sequence was converted into 0 and 1 numbers, and "0" was included in the control group, and "1" was included in the experimental group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	整个过程对研究者、患者不设盲，对实施终点指标评价的人员及统计专家设盲。
Blinding：	The whole process was not blinded to the investigators and patients, and was blinded to the personnel who evaluated the end points and statisticians.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是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）：	采用网络平台：中国知网https://www.cnki.net/
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	China National Knowledge Infrastructure https://www.cnki.net/
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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form, CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2023-12-27 16:41:08