滋肾安宁方治疗心肾不交型围绝经期综合征失眠伴抑郁、焦虑症状的临床观察

注册号:

Registration number:

ITMCTR2022000043

最近更新日期:

Date of Last Refreshed on:

2022-07-29

注册时间:

Date of Registration:

2022-07-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

滋肾安宁方治疗心肾不交型围绝经期综合征失眠伴抑郁、焦虑症状的临床观察

Public title:

Clinical observation of the treatment of heart-kidney incompatibility perimenopausal syndrome insomnia with symptoms of depression and anxiety

注册题目简写:

English Acronym:

研究课题的正式科学名称:

滋肾安宁方治疗心肾不交型围绝经期综合征失眠伴抑郁、焦虑症状的临床观察

Scientific title:

Clinical observation of the treatment of heart-kidney incompatibility perimenopausal syndrome insomnia with symptoms of depression and anxiety

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:

ChiCTR2200062186 ; ChiMCTR2200006387

申请注册联系人:

董立华

研究负责人:

谢京红

Applicant:

Lihua Dong

Study leader:

Jinghong Xie

申请注册联系人电话:

Applicant telephone:

18790299948

研究负责人电话:

Study leader's telephone:

13522612006

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:

jinghongxie2012@163.com

研究负责人电子邮件:

Study leader's E-mail:

jinghongxie2012@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 海淀区 西苑操场1号 中国中医科学院西苑医院

研究负责人通讯地址:

北京市 海淀区 西苑操场1号 中国中医科学院西苑医院

Applicant address:

No.1 Xiyuan Playground, Haidian District, Beijing Xiyuan Hospital, China Academy of Chinese Medical Sciences

Study leader's address:

No.1 Xiyuan Playground, Haidian District, Beijing Xiyuan Hospital, China Academy of Chinese Medical Sciences

申请注册联系人邮政编码:

Applicant postcode:

100091

研究负责人邮政编码:

Study leader's postcode:

100091

申请人所在单位:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

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:

2022XLA105-2

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Xiyuan Hospital Ethics Committee, No. 1 Xiyuan Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2022/7/8 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Mingjie Zi

伦理委员会联系地址:

中国中医科学院西苑医院1号院 西苑医院伦理委员会

Contact Address of the ethic committee:

Xiyuan Hospital Ethics Committee, No. 1 Xiyuan Hospital, China Academy of Chinese Medical Sciences

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

XiyuanLunli@126.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市 海淀区 西苑操场1号 中国中医科学院西苑医院

Primary sponsor's address:

No.1 Xiyuan Playground, Haidian District, Beijing Xiyuan Hospital, China Academy of Chinese Medical Sciences

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):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市 海淀区 西苑操场1号 中国中医科学院西苑医院

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Address:

No.1 Xiyuan Playground, Haidian District, Beijing Xiyuan Hospital, China Academy of Chinese Medical Sciences

经费或物资来源:

院拨经费

Source(s) of funding:

The hospital allocates funds

研究疾病:

围绝经期综合征失眠伴抑郁焦虑

研究疾病代码:

Target disease:

Perimenopausal syndrome insomnia with depression and anxiety

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:

通过客观观察有效药物滋肾安宁方治疗围绝经期女性诸多不适,改善围绝经期女性失眠伴抑郁焦虑症状,提高围绝经期妇女的生活质量,为临床解决目前存在的难题提供有效实用的参考,为临床治疗围绝经期失眠伴抑郁、焦虑症状患者提供临床疗效证据,以及新的诊疗思路,填补此方面的不足。

Objectives of Study:

Through objective observation of effective drugs to nourish the kidneys and tranquilizers to treat many discomforts in perimenopausal women, improve the symptoms of insomnia with depression and anxiety in perimenopausal women, improve the quality of life of perimenopausal women, provide an effective and practical reference for clinical solutions to the existing problems, provide clinical efficacy evidence for the clinical treatment of patients with perimenopausal insomnia with depression and anxiety symptoms, and provide new diagnosis and treatment ideas to fill in this aspect.

药物成份或治疗方案详述:

滋肾安宁方,药物组成:制龟板20g、太子参15g、菟丝子20g、麸炒白术10g、炙甘草10g、知母10g、黄柏10g、女贞子10g、栀子10g、柏子仁20g、大枣20g、丹参15g。 坤泰胶囊是由熟地黄、黄连、白芍、阿胶、黄芩、茯苓等组成,功效是:滋阴清热、安神除烦;主要用于治疗心烦不宁、失眠多梦、潮热汗出、头晕耳鸣、腰膝酸软、手足心热的阴虚火旺型绝经前后诸症;

Description for medicine or protocol of treatment in detail:

Zi shen an ning fang, drug composition: turtle plate 20g, taizi ginseng 15g, silk seed 20g, bran stir-fried white art 10g, hot licorice 10g, Zhimu 10g, yellow cedar 10g, female virgin 10g, gardenia 10g, cypress kernel 20g, jujube 20g, salvia 15g. Kuntai capsule is composed of cooked yellow, huanglian, white peony, ejiao, skullcap, poria and so on, the effect is: nourishing yin and clearing heat, calming the spirit and eliminating troubles; It is mainly used for the treatment of pre- and postmenopausal diseases of upset, insomnia and dreams, hot flashes and sweating, dizziness and tinnitus, waist and knee soreness, and hot hands and feet;

纳入标准:

1年龄45-55岁的围绝经期女性。 2符合失眠、抑郁、焦虑的诊断标准及评分依据。 3符合中医辨证心肾不交型的诊断标准。 4对本研究药物无过敏史。 5自愿参加本研究,并签署知情同意书。

Inclusion criteria

1 perimenopausal female aged 45-55 years. 2 Meet the diagnostic criteria and scoring basis for insomnia, depression and anxiety. 3 Meet the diagnostic criteria of TCM dialectical heart-kidney incompatibility. 4There is no history of allergy to the drug under study. 5. Voluntarily participate in this study and sign an informed consent form.

排除标准:

1合并心、肝、肾功能不全等原发性疾病,不适合参加本实验的患者。 2因脑供血不足、心脑血管疾病、中毒、五官科疾病等引起的器质性失眠患者。 3其他精神疾病(围绝经期抑郁焦虑外)或各种药物等其他因素导致失眠的患者。 4汉密顿抑郁量表(24项)>35分,和或汉密顿焦虑量表(14项)>29分的重度抑郁、焦虑症状的患者。 5正在进行并继续进行激素替代疗法治疗或其他中医治疗;或近4周内接受过失眠以及抑郁焦虑规范治疗的患者。 6有如吸毒、吸烟、酗酒、夜间长时间玩手机电脑等不良生活习惯,可能影响睡眠的患者。 7有严重器质性妇科疾病,比如宫颈癌、肿瘤等的患者。 8有生育需求的患者。 9采取曼月乐环等含有雌、孕激素成分避孕环避孕的患者。 10有严重失眠、抑郁、焦虑症状并影响生活,需服西药的患者。 11有严重药物过敏的患者。

Exclusion criteria:

1 Patients with primary diseases such as cardiac, hepatic, and renal insufficiency are not suitable for patients participating in this experiment. 2 Patients with organic insomnia caused by insufficient cerebral blood supply, cardiovascular and cerebrovascular diseases, poisoning, and diseases of the five senses. 3 Patients with insomnia caused by other psychiatric disorders (in addition to perimenopausal depression and anxiety) or other factors such as various drugs. 4 Patients with severe depression and anxiety symptoms > 35 points on the Hamilton Depression Scale (24 items) and or the Hamiltonian Anxiety Scale (14 items) > 29 points. 5 ongoing and continuing hormone replacement therapy treatment or other TCM treatments; or patients who have undergone normative treatment for insomnia and depression and anxiety within the last 4 weeks. 6 There are bad living habits such as drug use, smoking, alcoholism, and long-term playing of mobile phones and computers at night, which may affect sleep. 7 Patients with severe organic gynecological diseases, such as cervical cancer, tumors, etc. 8 Patients with fertility needs. 9 Patients who take contraceptive rings containing estrogen and progesterone components such as Manyuele rings for contraception. 10 Patients with severe insomnia, depression, anxiety symptoms that affect life and need to take Western medicine. 11 patients with severe drug allergies.

研究实施时间:

Study execute time:

From 2022-07-18

To      2022-12-31

征募观察对象时间:

Recruiting time:

From 2022-07-18

To      2022-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

42

Group:

Control group

Sample size:

干预措施:

予坤泰胶囊口服2个月

干预措施代码:

Intervention:

Give Kuntai capsules orally for 2 months

Intervention code:

组别:

治疗组

样本量:

42

Group:

Treatment group

Sample size:

干预措施:

予滋肾安宁方汤药口服2个月

干预措施代码:

Intervention:

Give kidney tranquility prescription decoction orally for 2 months

Intervention code:

样本总量 Total sample size : 84

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

单位级别:

中国中医科学院西苑医院

Institution/hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

测量指标:

Outcomes:

指标中文名:

国内改良Kupperman评定量表

指标类型:

次要指标

Outcome:

Domestic improvement of the Kupperman rating scale

Type:

Secondary indicator

测量时间点:

入组前、后分别填写1次

测量方法:

研究者辅助、指导患者客观填写

Measure time point of outcome:

Measure method:

指标中文名:

血清性激素E2、FSH、LH

指标类型:

次要指标

Outcome:

Serum sex hormones E2, FSH, LH

Type:

Secondary indicator

测量时间点:

入组前、后分别抽血化验

测量方法:

入组前、后分别抽血化验

Measure time point of outcome:

Measure method:

指标中文名:

汉密顿抑郁量表

指标类型:

次要指标

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator

测量时间点:

入组前、后分别填写1次

测量方法:

研究者辅助、指导患者客观填写

Measure time point of outcome:

Measure method:

指标中文名:

血常规、尿常规、心电图、肝功能、肾功能。

指标类型:

附加指标

Outcome:

Blood count, urine routine, electrocardiogram, liver function, kidney function.

Type:

Additional indicator

测量时间点:

入组前、后分别抽血化验1次

测量方法:

入组前、后分别抽血化验1次

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜厚度

指标类型:

次要指标

Outcome:

Endometrial thickness

Type:

Secondary indicator

测量时间点:

入组前、后分别行B超检查1次

测量方法:

入组前、后分别行B超检查1次

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量量表

指标类型:

主要指标

Outcome:

Pittsburgh Sleep Mass Scale

Type:

Primary indicator

测量时间点:

入组前、后分别填写1次

测量方法:

研究者辅助、指导患者客观填写

Measure time point of outcome:

Measure method:

指标中文名:

汉密顿焦虑量表

指标类型:

次要指标

Outcome:

Hamilton Anxiety Scale

Type:

Secondary indicator

测量时间点:

入组前、后分别填写1次

测量方法:

研究者辅助、指导患者客观填写

Measure time point of outcome:

Measure method:

指标中文名:

中医证候记分量表

指标类型:

次要指标

Outcome:

TCM Syndrome Sub-List

Type:

Secondary indicator

测量时间点:

入组前、后分别填写1次

测量方法:

研究者辅助、指导患者客观填写

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:

静脉

Sample Name:

blood

Tissue:

vein

人体标本去向

使用后销毁

说明

检验科化验

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 45
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):

由中国中医科学院西苑医院GCP中心有关人员通过随机数表法产生随机序列。

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

The-Random sequences are generated by the GCP Center of Xiyuan Hospital of China Academy of Chinese Medical Sciences through the random number table method.

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):

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

no

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:

病历记录表

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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