麦栀解忧方治疗阈下抑郁:以患者为中心的随机双盲安慰剂对照研究

注册号:

Registration number:

ITMCTR2025000260

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

麦栀解忧方治疗阈下抑郁:以患者为中心的随机双盲安慰剂对照研究

Public title:

The effectiveness of Maizhijieyou Decoction in treating subthreshold depression: a double-blind randomized placebo-controlled study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

麦栀解忧方治疗阈下抑郁:以患者为中心的随机双盲安慰剂对照研究

Scientific title:

The effectiveness of Maizhijieyou Decoction in treating subthreshold depression: a double-blind randomized placebo-controlled study

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:

钟碧莹

研究负责人:

韩振蕴

Applicant:

Biying Zhong

Study leader:

Zhenyun Han

申请注册联系人电话:

Applicant telephone:

18813966628

研究负责人电话:

Study leader's telephone:

13581647676

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:

zbytg2021@163.com

研究负责人电子邮件:

Study leader's E-mail:

tohanzhenyun@sina.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:

北京中医药大学

研究负责人通讯地址:

北京中医药大学东方医院

Applicant address:

Beijing university of Chinese medicine

Study leader's address:

Dongfang Hospital of Beijing University of Chinese Medicine

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

Applicant's institution:

Beijing university of Chinese medicine

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:

JDF-IRB-2024034002

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:

北京中医药大学东方医院临床研究伦理委员会

Name of the ethic committee:

IRB of Dongfang Hospital Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/15 0:00:00

伦理委员会联系人:

侯秀娟

Contact Name of the ethic committee:

Xiujuan Hou

伦理委员会联系地址:

北京中医药大学东方医院

Contact Address of the ethic committee:

Dongfang Hospital of Beijing University of Chinese Medicine

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-67654807

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dfyyec@126.com

研究实施负责(组长)单位:

北京中医药大学东方医院

Primary sponsor:

Dongfang Hospital of Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市丰台区方庄芳星园一区6号

Primary sponsor's address:

No. 6 Fangxingyuan Community Fangzhuang Fengtai District Beijing 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东方医院

具体地址:

北京市丰台区方庄芳星园一区6号

Institution
hospital:

Dongfang Hospital of Beijing University of Chinese Medicine

Address:

No. 6 Fangxingyuan Community Fangzhuang Fengtai District Beijing China

经费或物资来源:

北京中医药大学基本科研业务费揭榜挂帅项目

Source(s) of funding:

Beijing University of Chinese Medicine's Basic Research Business Fee Revealing and Leading Project

研究疾病:

阈下抑郁

研究疾病代码:

Target disease:

subthreshold 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:

其它

Others

研究目的:

通过开展多中心、双盲、安慰剂随机对照试验,从多方面融入“以患者为中心”概念,进行麦栀解忧方干预阈下抑郁的临床疗效及安全性评价研究,并探索其通过肠道菌群发挥疗效的可能机制,为阈下抑郁“中国方案”的形成提供可靠的证据支持。

Objectives of Study:

In order to establish a "Chinese plan" for treating subthreshold depression, a multicenter, double-blind, placebo-controlled trial would be carried out to assess the clinical efficacy and safety of Maizhijieyou decoction in treating the condition. Additionally, the trial aimed to investigate the potential mechanism of its effectiveness through intestinal flora.

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符合阈下抑郁诊断标准; ②年龄在 18 岁及以上,男女均可; ③签署知情同意书。 符合以上 3 项标准者方可纳入研究。

Inclusion criteria

① Meet the diagnostic criteria of subthreshold depression; ② Men and women aged 18 years and above; ③ signed the informed consent. Only those who met the above three criteria were included in the study.

排除标准:

①曾经或当下符合 DSM-5 对抑郁症诊断标准; ②专科医生评价不适宜参与试验的因素(例如最近有自残证据、当前有自杀自残 念头或行为、显著的认知损害); ③双相情感障碍或精神病性障碍; ④目前正在参与其他临床研究; ⑤已知的酗酒、吸毒等物质滥用史; ⑥有严重器质性疾病者、严重肝、肾功能损害者、严重心律失常或心功能不全者; ⑦妊娠、哺乳者和有妊娠计划者。 符合任何 1 项即予排除。

Exclusion criteria:

① met the DSM-5 criteria for depression; ② specialists' assessment of factors inappropriate for trial participation (e.g. recent evidence of self-harm current suicidal self-harm) Thoughts or behaviors significant cognitive impairment); ③ Bipolar disorder or psychotic disorder; ④ Currently participating in other clinical studies; ⑤ known history of alcohol and drug abuse; ⑥ patients with severe organic diseases severe liver or renal dysfunction severe arrhythmia or cardiac insufficiency; ⑦ Pregnant breastfeeding and planning pregnancy. Any of the above conditions shall be excluded.

研究实施时间:

Study execute time:

From 2025-01-15

To      2027-12-31

征募观察对象时间:

Recruiting time:

From 2025-02-20

To      2027-06-30

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

control group

Sample size:

干预措施:

麦栀解忧方安慰剂

干预措施代码:

Intervention:

Maizhijieyou decoction placebo

Intervention code:

组别:

试验组

样本量:

200

Group:

Experimental group

Sample size:

干预措施:

麦栀解忧方

干预措施代码:

Intervention:

Maizhijieyou decoction

Intervention code:

样本总量 Total sample size : 400

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

zhejiang

City:

单位(医院):

浙江大学医学院附属精神卫生中心

单位级别:

三甲医院

Institution/hospital:

Zhejiang University School of Medicine Affiliated Mental Health Center

Level of the institution:

Grade A tertiary hospital

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东方医院

单位级别:

三甲医院

Institution/hospital:

Dongfang Hospital of Beijing University of Chinese Medicine

Level of the institution:

Grade A tertiary hospital

国家:

中国

省(直辖市):

河北省

市(区县):

Country:

China

Province:

hebei

City:

单位(医院):

北京中医药大学东方医院秦皇岛医院

单位级别:

三甲医院

Institution/hospital:

Beijing University of Chinese Medicine Oriental Hospital Qinhuangdao Hospital (Qinhuangdao Traditional Chinese Medicine Hospital)

Level of the institution:

Grade A tertiary hospital

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

guangdong

City:

单位(医院):

北京中医药大学深圳医院(龙岗)

单位级别:

三甲医院

Institution/hospital:

Shenzhen Hospital of Beijing University of Chinese Medicine (Longgang)

Level of the institution:

Grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

患者健康问卷抑郁量表得分

指标类型:

主要指标

Outcome:

scores of Patient Health Questionnaire-9 (PHQ-9)

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:

尿常规

指标类型:

次要指标

Outcome:

Urine routine test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清肌酐

指标类型:

次要指标

Outcome:

Serum creatinine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

天门冬氨酸氨基转移酶

指标类型:

次要指标

Outcome:

Aspartate aminotransferase (AST)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

12项简明健康状况调查量表得分

指标类型:

次要指标

Outcome:

scores of 12-item short form health survey (SF-12)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙氨酸氨基转移酶

指标类型:

次要指标

Outcome:

Alanine aminotransferase (ALT)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

Blood routine test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛性焦虑障碍-7项量表得分

指标类型:

次要指标

Outcome:

scores of generalized anxiety disorder-7 scale (GAD-7)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医郁证证候量表得分

指标类型:

次要指标

Outcome:

scores of traditional Chinese medicine depression syndrome Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿素氮

指标类型:

次要指标

Outcome:

Blood urea nitrogen

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:

粪便

组织:

Sample Name:

faeces

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:

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 80
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):

采用分中心区组随机的方法,应用软件完成随机分配,计算机系统或密封袋完成分配隐藏,将纳入受试者按 1:1 比例分为对照组 200 例,实验组 200 例。

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

Using the method of sub-center block randomization the random allocation was completed by the software and the allocation was concealed by the computer system or sealed bag. The enrolled subjects were divided into the control group and the experimental group according to the ratio of 1:1 with 200 cases in each group.

盲法:

Blinding:

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):

2027-12-31 根据计划投稿的杂志要求公开数据

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

Publication of the data was requested by the journal for which the manuscript was to be submitted by 31 December 2027

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:

使用病例报告表进行数据的采集与记录,使用Epidata软件进行数据管理

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

Case report form was used to collect and record data, and Epidata software was used for data management

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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