补肾疏肝化瘀方治疗围绝经期抑郁的转录组测序研究

注册号:

Registration number:

ITMCTR2024000385

最近更新日期:

Date of Last Refreshed on:

2024-09-05

注册时间:

Date of Registration:

2024-09-05

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

补肾疏肝化瘀方治疗围绝经期抑郁的转录组测序研究

Public title:

Kidney and liver blood circulation of the treatment of perimenopausal depression transcriptome sequencing

注册题目简写:

补肾疏肝化瘀方治疗围绝经期抑郁的转录组测序研究

English Acronym:

Kidney and liver blood circulation of the treatment of perimenopausal depression transcriptome sequencing

研究课题的正式科学名称:

补肾疏肝化瘀方治疗围绝经期抑郁的转录组测序研究

Scientific title:

Kidney and liver blood circulation of the treatment of perimenopausal depression transcriptome sequencing

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:

冯子芹

研究负责人:

许凤全

Applicant:

Feng Ziqin

Study leader:

Xu Fengquan

申请注册联系人电话:

Applicant telephone:

18811532599

研究负责人电话:

Study leader's telephone:

010-88002676

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:

563862938@qq.com

研究负责人电子邮件:

Study leader's E-mail:

563862938@qq.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:

北京市西城区北线阁5号

研究负责人通讯地址:

北京市西城区北线阁5号

Applicant address:

Beijing xicheng district northern cabinet number five

Study leader's address:

Beijing xicheng district northern cabinet number five

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:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen Hospital

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:

2024-130-KY-01

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:

中国中医科学院广安门医院

Name of the ethic committee:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/23 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Qiao Jie

伦理委员会联系地址:

北京市西城区北线阁5号

Contact Address of the ethic committee:

Beijing xicheng district northern cabinet number five

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-88001552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

研究实施负责(组长)单位地址:

北京市西城区北线阁5号

Primary sponsor's address:

Beijing xicheng district northern cabinet number five

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):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Address:

Beijing xicheng district northern cabinet number five

经费或物资来源:

自筹

Source(s) of funding:

self-collected raise

研究疾病:

围绝经期抑郁

研究疾病代码:

Target disease:

Perimenopausal depression

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

病例研究

Case study

研究所处阶段:

Study phase:

其它

Others

研究目的:

通过分析补肾疏肝化瘀方治疗前后围绝经期抑郁患者的转录组测序结果,探究补肾疏肝化瘀方治疗围绝经期抑郁的潜在作用机制,以期为中医药治疗围绝经期抑郁提供新思路。

Objectives of Study:

To explore the potential mechanism of Bushen Shugan Huayu decoction in the treatment of perimenopausal depression by analyzing the transcriptome sequencing results of patients with perimenopausal depression before and after treatment with Bushen Shugan Huayu decoction in order to provide new ideas for the treatment of perimenopausal depression with traditional Chinese medicine.

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: ①自愿参加并签署知情同意书; 2: ②年龄45-65岁,围绝经期女性患者; 3: ③符合抑郁症(《中国精神疾病分类方案与诊断标准(第三版)》)的诊断标准,且汉密尔顿抑郁评定量表(HAMD)总分为8~34分; 4: ④符合中医“绝经前后诸证”的肾虚肝郁血瘀证(《中医妇科学》)的诊断标准; 5: ⑤拟予补肾疏肝化瘀方加减方治疗者; 6: ⑥未服用雌激素类药物或数月前停用者; 7: ⑦未服用精神科诸类药物,或1月前停用此类药物者。

Inclusion criteria

1: ① Voluntary participation and signed informed consent; 2: ② Perimenopausal women aged 45-65 years; 3: ③ meet the diagnostic criteria of depression (Chinese Classification of Mental Disorders and Diagnostic Criteria (Third edition)) and the total score of Hamilton Depression Rating Scale (HAMD) was 8-34; 4: ④ in accordance with the traditional Chinese medicine "all CARDS" before and after menopause kidney liver blood stasis (gynecology of traditional Chinese medicine) diagnostic criteria; 5: ⑤ proposed to party party for treatment for kidney and liver blood circulation; 6: ⑥ those who have not taken estrogen drugs or stopped taking estrogen drugs a few months ago; 7: ⑦ Those who did not take any psychiatric drugs or stopped taking such drugs before 1 month.

排除标准:

1: ①合并其他严重器质性疾病或精神病患者; 2: ②存在可能危及生命的心脑血管疾病; 3: ③既往3个月内有酒精或药滥用或依赖; 4: ④根据临床判断存在严重自杀危险; 5: ⑤子宫及卵巢全部切除患者; 6: ⑥纳入本研究之前一个月内曾经参加过药物研究的临床实验。

Exclusion criteria:

1: 1) merging other serious organic disease or mental illness; 2: 2) there may be a life-threatening disease of heart head blood-vessel. 3: 3) alcohol or drug abuse or dependence in the past 3 months; 4: 4) according to the clinical judgment exists serious suicide risk; 5: 5)patients with total hysterectomy and ovariectomy; 6: 6) having participated in a clinical trial of drug research within one month before enrollment.

研究实施时间:

Study execute time:

From 2024-07-24

To      2024-10-31

征募观察对象时间:

Recruiting time:

From 2024-07-24

To      2024-07-31

干预措施:

Interventions:

组别:

治疗前

样本量:

15

Group:

prior treatment

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

样本总量 Total sample size : 15

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):

--请选择--

Country:

China

Province:

Beijing

City:

----

单位(医院):

中国中医科学院广安门医院

单位级别:

三甲医院

Institution/hospital:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Level of the institution:

Class A tertiary hospital

测量指标:

Outcomes:

指标中文名:

汉密尔顿抑郁量表

指标类型:

主要指标

Outcome:

HAMD

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PBMC细胞基因表达水平

指标类型:

主要指标

Outcome:

Gene expression levels in PBMC cells

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:

正在进行

Recruiting

年龄范围:

最小 40
Min age years
最大 55
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机试验

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

Non randomized trial

盲法:

Blinding:

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):

不公开

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

not published

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:

使用病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

No

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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