益肾祛浊方治疗脾肾两虚阳明浊热证多囊卵巢综合征-胰岛素抵抗影响子宫内膜容受性的研究

注册号:

Registration number:

ITMCTR2024000014

最近更新日期:

Date of Last Refreshed on:

2024-01-27

注册时间:

Date of Registration:

2024-01-27

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

益肾祛浊方治疗脾肾两虚阳明浊热证多囊卵巢综合征-胰岛素抵抗影响子宫内膜容受性的研究

Public title:

A study on the effects of insulin resistance on the effects of insulin resistance on endometrial receptivity in the treatment of spleen and kidney deficiency and yang and yang turbidity fever syndrome

注册题目简写:

English Acronym:

研究课题的正式科学名称:

益肾祛浊方治疗脾肾两虚阳明浊热证多囊卵巢综合征-胰岛素抵抗影响子宫内膜容受性的研究

Scientific title:

A study on the effects of insulin resistance on the effects of insulin resistance on endometrial receptivity in the treatment of spleen and kidney deficiency and yang and yang turbidity fever syndrome

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:

张雅冬

研究负责人:

张雅冬

Applicant:

ZHANG Yadong

Study leader:

ZHANG Yadong

申请注册联系人电话:

Applicant telephone:

13651261126

研究负责人电话:

Study leader's telephone:

13651261126

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:

zhangyadong@bjzhongyi.com

研究负责人电子邮件:

Study leader's E-mail:

zhangyadong@bjzhongyi.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:

北京市东城区美术馆后街23号

研究负责人通讯地址:

北京市东城区美术馆后街23号

Applicant address:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

Study leader's address:

No. 23, Art Museum Back Street, Dongcheng 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:

首都医科大学附属北京中医医院

Applicant's institution:

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

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:

2023BL02-066-01

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:

首都医科大学附属北京中医医院医学伦理委员会

Name of the ethic committee:

张雅冬

伦理委员会批准日期:

Date of approved by ethic committee:

2023/6/5 0:00:00

伦理委员会联系人:

刘声

Contact Name of the ethic committee:

LIU SHENG

伦理委员会联系地址:

北京市东城区美术馆后街23号

Contact Address of the ethic committee:

No. 23, Art Museum Back Street, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

01087906734

伦理委员会联系人邮箱:

Contact email of the ethic committee:

liusheng4377@163.com

研究实施负责(组长)单位:

首都医科大学附属北京中医医院

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

研究实施负责(组长)单位地址:

首都医科大学附属北京中医医院

Primary sponsor's address:

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

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):

北京市

Country:

Province:

北京市

City:

北京市

单位(医院):

首都医科大学附属北京中医医院

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Address:

经费或物资来源:

北京市医管局培育项目

Source(s) of funding:

Beijing Hospital Management Center Cultivation Project

研究疾病:

多囊卵巢综合征

研究疾病代码:

Target disease:

PCOS

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:

益肾祛浊方治疗PCOS-IR患者(脾肾两虚阳明浊热证)的有效性与安全性。

Objectives of Study:

Efficacy and safety of Yi Kidney Turbidity Formula in the treatment of PCOS-IR patients (spleen and kidney deficiency and yang ming turbidity heat 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)符合上述西医诊断标准和中医证候标准者; (2)年龄在18~40岁的患者; (3)1个月内未服用治疗PCOS药物 (4)坚持口服中药治疗并配合完成观察者。

Inclusion criteria

(1) Those who meet the above criteria for Western medicine diagnosis and TCM syndrome; (2) Patients aged 18~40 years old; (3) Not taking medication for PCOS within 1 month (4) Adhere to oral Chinese medicine treatment and cooperate with the completion of the observer.

排除标准:

(1)合并有生殖器官器质性病变者; (2)心脑血管、肝肾及造血系统等严重原发性疾病患者; (3)精神或法律上的残疾者或不具备个人行事能力者; (4)已诊断为卵巢功能低下者; (5)已诊断为糖尿病者。

Exclusion criteria:

(1) Patients with organic lesions of genital organs; (2) Patients with severe primary diseases such as cardiovascular and cerebrovascular, liver and kidney, and hematopoietic system; (3) Persons with mental or legal disabilities or inability to act on their own; (4) Those who have been diagnosed with ovarian hypofunction; (5) Those who have been diagnosed with diabetes.

研究实施时间:

Study execute time:

From 2023-06-05

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2023-06-05

To      2025-12-31

干预措施:

Interventions:

组别:

试验组

样本量:

34

Group:

experimental group

Sample size:

干预措施:

益肾祛浊方

干预措施代码:

Intervention:

yishenquzhuo formula

Intervention code:

组别:

对照组

样本量:

34

Group:

control group

Sample size:

干预措施:

二甲双胍

干预措施代码:

Intervention:

metformin

Intervention code:

样本总量 Total sample size : 68

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):

Country:

China

Province:

Beijnig

City:

单位(医院):

首都医科大学附属北京中医医院

单位级别:

三甲

Institution/hospital:

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

排卵率

指标类型:

主要指标

Outcome:

ovaration rate

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵泡数目

指标类型:

次要指标

Outcome:

follicle number

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体质量指数

指标类型:

次要指标

Outcome:

BMI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素

指标类型:

副作用指标

Outcome:

UREA

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫动脉血流阻力指数

指标类型:

次要指标

Outcome:

RI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗苗勒管激素

指标类型:

次要指标

Outcome:

AMH

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状积分

指标类型:

次要指标

Outcome:

Clinical Symptom Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜形态

指标类型:

次要指标

Outcome:

Endometrial morphology

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄体生成素

指标类型:

次要指标

Outcome:

LH

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素

指标类型:

次要指标

Outcome:

insulin

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷草转氨酶

指标类型:

副作用指标

Outcome:

AST

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

副作用指标

Outcome:

ALT

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵巢体积

指标类型:

次要指标

Outcome:

ovarian volume

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫动脉血流搏动指数

指标类型:

次要指标

Outcome:

PI

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:

副作用指标

Outcome:

blood routine

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睾酮

指标类型:

次要指标

Outcome:

T

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜动脉血流阻力指数

指标类型:

次要指标

Outcome:

RI

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:

副作用指标

Outcome:

urine routine

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵泡刺激素

指标类型:

次要指标

Outcome:

FSH

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐

指标类型:

副作用指标

Outcome:

Cr

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜血流搏动指数

指标类型:

次要指标

Outcome:

PI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

次要指标

Outcome:

GLU

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最大卵泡直径

指标类型:

次要指标

Outcome:

Maximum follicle diameter

Type:

Secondary indicator

测量时间点:

测量方法:

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:

EM

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:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 40
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):

研究将收集68例PCOS-IR患者,采用密闭信封法,确定好区组长度,给定种子数,借助SAS统计软件PROC PLAN过程语句,列出流水号,将每一流水号所对应的治疗分配信笺密封入不透光信封内形成随机信件,依次拆阅,将其分为中药试验组(34例)、西药对照组(34例)。

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

In this study, 68 patients with PCOS-IR will be collected, the closed envelope method will be used to determine the length of the block, the number of seeds will be given, and the serial number will be listed with the help of the process statement of the SAS statistical software PROC PLAN, and the treatment allocation letterhead corresponding to each serial number will be sealed into opaque envelopes to form random letters, which will be opened in turn and divided into the traditional Chinese medicine test group (34 cases) and the western medicine control group (34 cases).

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):

试验完成后6个月公开,共享方式: 向研究者联系索取

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

Open 6 months after completion of the trial, sharing method: contact the investigator for a copy.

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:

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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