桂姜仙茶方针对脾肾阳虚型超重/肥胖患者的临床研究

注册号:

Registration number:

ITMCTR2023000002

最近更新日期:

Date of Last Refreshed on:

2023-03-22

注册时间:

Date of Registration:

2023-03-22

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

桂姜仙茶方针对脾肾阳虚型超重/肥胖患者的临床研究

Public title:

Clinical Study of Guijiangxiancha Formula on Overweight/Obesity Patients with Yang Deficiency of Spleen and Kidney

注册题目简写:

English Acronym:

研究课题的正式科学名称:

桂姜仙茶方针对脾肾阳虚型超重/肥胖患者的临床研究

Scientific title:

Clinical Study of Guijiangxiancha Formula on Overweight/Obesity Patients with Yang Deficiency of Spleen and Kidney

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:

张晋

研究负责人:

张晋

Applicant:

Zhang Jin

Study leader:

Zhang Jin

申请注册联系人电话:

Applicant telephone:

+8613911893296

研究负责人电话:

Study leader's telephone:

+8613911893296

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:

13911893296@163.com

研究负责人电子邮件:

Study leader's E-mail:

13911893296@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

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

1 Xiyuan Playground, Haidian District, Beijing, China

Study leader's address:

1 Xiyuan Playground, Haidian District, Beijing, China

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:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital of 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:

2022XLA170-2

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伦理委员会

Name of the ethic committee:

EC of Xi Yuan Hospital of China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2023/2/14 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Zi Mingjie

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

1 Xiyuan Playground, Haidian District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital of 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

Primary sponsor's address:

1 Xiyuan Playground, Haidian 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):

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

Institution
hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Address:

1 Xiyuan Playground, Haidian District, Beijing,China

经费或物资来源:

中国中医科学院科技创新工程项目资助

Source(s) of funding:

Scientific and technological innovation project of Chinese Medical Sciences

研究疾病:

超重/肥胖症

研究疾病代码:

Target disease:

Overweight/Obesity

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:

通过临床试验,探究桂姜仙茶方针对脾肾阳虚型超重/肥胖患者的临床疗效及安全性。

Objectives of Study:

This 12-week clinical study will evaluate the clinical efficacy and safety of Guijiangxiancha formula in Chinese patients with overweigt or obesity due to yang deficiency of the spleen and kidney.

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)符合超重/肥胖西医诊断标准; (2)符合中医辨证标准; (3)年龄18-65岁,男女不限; (4)自愿参与本试验,愿意配合治疗,并签署知情同意书

Inclusion criteria

(1)Cases meet the Western diagnostic criteria for overweight/obesity; (2)Cases neet the TCM syndrome differentiation standards; (3)Patients between the ages of 18 and 65 years , of either sex. (4)Volunteering to participate in this trial ,Willing to cooperate with treatment and Signing informed consent form. )

排除标准:

(1)继发性肥胖、肥胖相关疾病严重并发症、恶性肿瘤、严重心脏疾病、严重血液系统疾病等; (2)存在贫血或血红蛋白水平异常者; (3)肝肾功能不全、感染性疾病等; (4)中医辨证为血虚而无气滞血瘀者; (5)近3个月服用过减重药物者; (6)对试验药物组方成分过敏的患者; (7)既往或目前有严重精神疾病的患者; (8)妊娠或近3个月准备妊娠的妇女及哺乳期妇女; (9)近1个月内参加其他临床试验的患者; (10)研究者认为不宜参加本研究者。

Exclusion criteria:

(1)Cases of secondary obesityserious complications of obesity-related diseasesmalignant tumors, severe heart diseases, serious blood system diseases; (2)Patients with anemia or abnormal hemoglobin levels; (3)Patients with liver and kidney insufficiency or infectious diseases; (4)Syndrome differentiation of TCM is blood deficiency without qi stagnation and blood stasis; (5)Patients have taken weight loss drugs in the past three months; (6)Patients who are allergic to the composition of the test drug prescription; (7)Patients with previous or current serious mental illness. (8) Pregnancy, prepare to pregnant in recent three months or in lactation; (9)Participated in other clinical trials in recent one month or currently join another tria. (10)The researchers think it is not appropriate for clinical participants.

研究实施时间:

Study execute time:

From 2023-04-01

To      2024-10-01

征募观察对象时间:

Recruiting time:

From 2023-04-01

To      2024-04-01

干预措施:

Interventions:

组别:

试验组

样本量:

31

Group:

Experimental group

Sample size:

干预措施:

健康教育+常规膳食指导+桂姜仙茶方

干预措施代码:

Intervention:

Health education+Routine dietary guidance+Guijiangxiancha Formula

Intervention code:

组别:

对照组

样本量:

31

Group:

Control group

Sample size:

干预措施:

健康教育+常规膳食指导

干预措施代码:

Intervention:

Health education+Routine dietary guidance

Intervention code:

样本总量 Total sample size : 62

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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等

Institution/hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

红外热成像图

指标类型:

次要指标

Outcome:

Infrared thermal imaging map

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素抵抗指数

指标类型:

次要指标

Outcome:

HOMA-IR

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰围

指标类型:

次要指标

Outcome:

Waist circumference

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白

指标类型:

次要指标

Outcome:

HDL-C

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

次要指标

Outcome:

TNF-α

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

次要指标

Outcome:

TC

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标

Outcome:

FPG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素作用指数

指标类型:

次要指标

Outcome:

IAI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白

指标类型:

次要指标

Outcome:

LDL-C

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

次要指标

Outcome:

TG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素分泌指数

指标类型:

次要指标

Outcome:

HOMA-β

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

臀围

指标类型:

次要指标

Outcome:

Hip circumference

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

次要指标

Outcome:

FINS

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:

主要指标

Outcome:

Syndrome score of TCM

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标

Outcome:

Weight

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体成分分析

指标类型:

次要指标

Outcome:

Human body composition analysis

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

使用后保存

说明

Fate of sample 

Preservation 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 65
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):

研究者根据随机数字表法进行随机化分配

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

The researchers carry out random distribution according to the random digital 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):

在试验完成后通过文章发表

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

Publish paper after the trial complete

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:

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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