A study on the therapeutic effect and dosage relationship of embedding thread at different depths at eight periumbilical acupoints for treating abdominal simple obesity due to spleen deficiency and dampness retention

注册号:

Registration number:

ITMCTR2024000432

最近更新日期:

Date of Last Refreshed on:

2024-09-13

注册时间:

Date of Registration:

2024-09-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

脐周八穴不同深度穴位埋线治疗脾虚湿阻腹型单纯性肥胖的量效研究

Public title:

A study on the therapeutic effect and dosage relationship of embedding thread at different depths at eight periumbilical acupoints for treating abdominal simple obesity due to spleen deficiency and dampness retention

注册题目简写:

English Acronym:

研究课题的正式科学名称:

脐周八穴不同深度穴位埋线治疗脾虚湿阻腹型单纯性肥胖的量效研究

Scientific title:

A study on the therapeutic effect and dosage relationship of embedding thread at different depths at eight periumbilical acupoints for treating abdominal simple obesity due to spleen deficiency and dampness retention

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:

黄珍珍

研究负责人:

黄珍珍

Applicant:

HuangZhenzhen

Study leader:

HuangZhenzhen

申请注册联系人电话:

Applicant telephone:

13141219688

研究负责人电话:

Study leader's telephone:

13141219688

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:

1922320504@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1922320504@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:

北京市大兴区黄村西大街26号

研究负责人通讯地址:

北京市大兴区黄村西大街26号

Applicant address:

No. 26 Huangcun West Street Daxing District Beijing

Study leader's address:

No. 26 Huangcun West Street Daxing 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:

北京市大兴区人民医院

Applicant's institution:

Beijing Daxing District People's 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:

271069-2024-27

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京市大兴区人民医院伦理委员会医学科学研究伦理审查分会

Name of the ethic committee:

Medical Science Research Ethics Review Branch of the Ethics Committee of Daxing District People's Hospital Beijing

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/19 0:00:00

伦理委员会联系人:

张东海

Contact Name of the ethic committee:

Zhang Donghai

伦理委员会联系地址:

北京市大兴区人民医院

Contact Address of the ethic committee:

Beijing Daxing District People's Hospital

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-60283944

伦理委员会联系人邮箱:

Contact email of the ethic committee:

kjk60283150@163.com

研究实施负责(组长)单位:

北京市大兴区人民医院

Primary sponsor:

Beijing Daxing District People's Hospital

研究实施负责(组长)单位地址:

北京市大兴区黄村西大街26号

Primary sponsor's address:

No. 26 Huangcun West Street Daxing District Beijing

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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市大兴区人民医院

具体地址:

北京市大兴区黄村西大街26号

Institution
hospital:

Beijing Daxing District People's Hospital

Address:

No. 26 Huangcun West Street Daxing District Beijing

经费或物资来源:

院级课题(2024年度大兴区人民医院院级课题)

Source(s) of funding:

Hospital level Project (2024 Daxing District People's Hospital Hospital level Project)

研究疾病:

单纯性肥胖

研究疾病代码:

Target disease:

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:

其它

Others

研究目的:

通过观察脐周八穴不同埋置深度干预的穴位埋线疗法治疗脾虚湿阻腹型单纯性肥胖患者治疗前后的体质量、体质量指数(BMI)、腰围(WC)、臀围、腰臀比(WHR)、肥胖度(A)、脂肪百分率(F%)、皮褶厚度等指标的变化情况,评价两组临床疗效,探寻两组是否存在刺激量上的疗效差异,为临床优化方案的选取及规范化诊疗提供证据。

Objectives of Study:

Through the observation of changes in body mass body mass index (BMI) waist circumference (WC) hip circumference waist-to-hip ratio (WHR) obesity degree (A) fat percentage (F%) and skin fold thickness before and after treatment in simple obese patients with spleen deficiency and dampness-induced abdominal obstruction who underwent acupoint thread embedding therapy with varying depths at the periumbilical points we evaluated the clinical efficacy of the two groups investigated any differences in therapeutic effects based on the amount of stimulation and provided evidence for the selection of optimized clinical protocols and standardized diagnostic and treatment practices.

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: 1.2.2 诊断标准 1.2.2.1 西医诊断标准 参照全国第五届肥胖病研究学术会议修定的《单纯性肥胖病的诊断及疗效评定标准》制定: (1)病史、体格检查或实验室检查排除症状性肥胖(继发性肥胖)。 (2)体重指数(BMI)超过26;实测体重超过标准体重的20%以上;脂肪百分率(F%)≥30%(女性 F%≥35%);3项中有2项及2项以上符合者可诊断为单纯性肥胖。且结合参照《中国成人超重和肥胖症预防控制指南》男性WC≥ 85cm、女性WC≥80cm作为腹型单纯性肥胖的标准。 (3)体重指数、肥胖度、脂肪百分率计算方法如下: ① 体重指数(BMI)=体重(kg)÷[身高(m)]2,单位用kg/m 2表示。≥25~26为超重;>26~<30属于轻度肥胖,≥30~<40 属于中度肥胖,≥40属重度肥胖。 ② 肥胖度=[(实测体重-标准体重)/标准体重]×100%,单位用%表示。肥胖度≥10%~20%为超重,≥20%为肥胖(轻度肥胖),≥30%为中度肥胖,≥50%为重度肥胖。 标准体重(kg)=[身高(cm)-100]×0.9。 ③ 脂肪百分率(F%)=(4.570/D-4.142)×100%。其中体密度(D)依照附录1 测算,然后代入公式内,单位用%表示。其中>25~<30(男性)/30~<35(女性)者为超重;30~<35(男性)/ 35~< 40(女性)为轻度肥胖;35~< 45(男性)/40~<50(女性)为中度肥胖;> 45(男性)/> 50(女性)以上者为重度肥胖。 1.2.2.2 中医诊断标准 参照全国第五届肥胖病研究学术会议修定的《单纯性肥胖病的诊断及疗效评定标准》中单纯性肥胖病的中医辨证分型标准制定: 脾虚湿阻型:肥胖,浮肿,疲乏无力,肢体困重,尿少,纳差,腹满,脉沉细,舌苔薄腻,舌质淡红。除主证肥胖外,其他症状符合 2-3项以上,舌、脉象基本与之相符,即可诊断为该型。 纳入标准 (1)符合上述西医诊断标准; (2)符合上述中医辨证分型标准; (3)年龄 20~55岁; (4)最近3个月内未曾接受其他任何减肥方式治疗; (5)自愿参加本研究并签署知情同意书者。

Inclusion criteria

1: 1.2.2 Diagnostic criteria 1.2.2.1 Western medicine diagnostic criteria refer to the "Diagnostic and Therapeutic Evaluation Criteria for Simple Obesity" revised at the 5th National Conference on Obesity Research: (1) Medical history physical examination or laboratory tests exclude symptomatic obesity (secondary obesity). (2) Body mass index (BMI) exceeding 26; The measured weight exceeds the standard weight by more than 20%; Fat percentage (F%) ≥ 30% (female F% ≥ 35%); If two or more of the three criteria are met it can be diagnosed as simple obesity. And combined with the "Chinese Guidelines for the Prevention and Control of Overweight and Obesity in Adults" male WC ≥ 85cm and female WC ≥ 80cm are used as the criteria for abdominal simple obesity. (3) The calculation methods for body mass index obesity level and fat percentage are as follows: ① Body mass index (BMI)=weight (kg) ÷ [height (m)] 2 expressed in kg/m2 25-26 is considered overweight 26 to<30 is considered mild obesity ≥ 30 to<40 is considered moderate obesity and ≥ 40 is considered severe obesity Obesity degree=[(measured weight standard weight)/standard weight] × 100% expressed in%. Obesity levels of ≥ 10% to 20% indicate overweight ≥ 20% indicate obesity (mild obesity) ≥ 30% indicate moderate obesity and ≥ 50% indicate severe obesity. Standard weight (kg)=[height (cm) -100] × 0.9. ③ Fat percentage (F%)=(4.570/D-4.142) × 100%. The bulk density (D) is calculated according to Appendix 1 and then substituted into the formula expressed in%. Among them those with>25~<30 (male)/30~<35 (female) are overweight; 30 to<35 (male)/35 to<40 (female) indicates mild obesity; 35 to<45 (male)/40 to<50 (female) is moderate obesity Individuals with a ratio of 45 (male) to over 50 (female) are considered severely obese. 1.2.2.2 Traditional Chinese Medicine (TCM) diagnostic criteria refer to the "Diagnostic and Therapeutic Evaluation Criteria for Simple Obesity" revised at the 5th National Conference on Obesity Research. The TCM syndrome differentiation criteria for simple obesity are as follows: spleen deficiency and dampness obstruction type: obesity edema fatigue and weakness heavy limb fatigue oliguria poor appetite full belly deep and thin pulse thin and greasy tongue coating and pale red tongue texture. Except for the main symptom of obesity if other symptoms meet 2-3 or more criteria and the tongue and pulse are basically consistent with it the diagnosis of this type can be made. Inclusion criteria (1) meet the diagnostic criteria of Western medicine mentioned above; (2) Meet the above TCM syndrome differentiation and typing standards; (3) Age range from 20 to 55 years old; (4) I have not received any other weight loss treatment in the past 3 months; (5) Those who voluntarily participate in this study and sign the informed consent form.

排除标准:

1: 排除标准 (1)继发性肥胖,如下丘脑、垂体疾病、甲状腺功能低下、皮质醇增多、胰岛素增多、性腺分泌变化及药物引起的继发性肥胖症患者; (2)合并有心、肝、肾、造血系统等重要器官或系统严重原发性疾病者; (3)合并有神经、精神疾患而无法合作,或不愿合作者; (4)妊娠期或哺乳期妇女以及近期有生育计划者; (5)对酒精、动物蛋白过敏史者; (6)瘢痕体质患者; (7)最近 3个月内曾接受其他任何减肥方式治疗者; (8)年龄小于20岁或大于55岁的患者。

Exclusion criteria:

1: Exclusion criteria (1) Secondary obesity including patients with hypothalamic and pituitary diseases hypothyroidism increased cortisol increased insulin changes in gonadal secretion and drug-induced secondary obesity; (2) Patients with severe primary diseases of important organs or systems such as heart liver kidney hematopoietic system etc; (3) Individuals with neurological or mental disorders who are unable to cooperate or unwilling to cooperate; (4) Pregnant or lactating women and those with recent fertility plans; (5) Individuals with a history of allergies to alcohol and animal protein; (6) Scar constitution patients; (7) Individuals who have received any other weight loss treatment within the past 3 months; (8) Patients under 20 years old or over 55 years old.

研究实施时间:

Study execute time:

From 2024-06-01

To      2026-05-31

征募观察对象时间:

Recruiting time:

From 2024-09-15

To      2025-09-30

干预措施:

Interventions:

组别:

脐周八穴埋置深度50mm组

样本量:

42

Group:

Eight acupoints around the navel buried at a depth of 50mm group

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

catgut implantation at acupoint

Intervention code:

组别:

脐周八穴埋置深度25mm组

样本量:

42

Group:

Eight acupoints around the navel buried at a depth of 25mm group

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

catgut implantation at acupoint

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):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市大兴区人民医院

单位级别:

三级综合

Institution/hospital:

Beijing Daxing District People's Hospital

Level of the institution:

Third level comprehensive

测量指标:

Outcomes:

指标中文名:

体质量指数(BMI)

指标类型:

次要指标

Outcome:

Body Mass Index (BMI)

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

体质量

指标类型:

次要指标

Outcome:

weight

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

肥胖度

指标类型:

次要指标

Outcome:

Obesity Degree

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

脂肪百分率

指标类型:

次要指标

Outcome:

Fat percentage

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

皮褶厚度

指标类型:

次要指标

Outcome:

skinfold thickness

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

疗效评价(临床痊愈、显效、有效、无效)

指标类型:

主要指标

Outcome:

Efficacy evaluation (clinical cure significant effect effective ineffective)

Type:

Primary indicator

测量时间点:

治疗两个疗程后进行评价

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:

hipline

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

腰臀比

指标类型:

次要指标

Outcome:

Waist-Hip Ratio

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

指标中文名:

腰围(WC)

指标类型:

次要指标

Outcome:

Waist circumference (WC)

Type:

Secondary indicator

测量时间点:

(治疗前、后及治疗后1个月进行测量)

测量方法:

Measure time point of outcome:

(Measurements taken before after and 1 month after treatment)

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 55
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):

简单随机法(研究者运用随机数字表法产生随机数列)

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

simple randomization(The researchers used the random number table method to generate random numbers)

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,使用临床试验公共管理平台ResMan(www.medresman.org))向公众开放查询

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

After the completion of the trial, the clinical trial public management platform ResMan (www.edresman. org) will be used to open queries to the public

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:

本研究采用规范化的数据采集和管理系统:为病例记录表+基于互联网的EDC系统。 基于互联网的电子数据采集和管理系统(EDC)使用临床试验公共管理平台ResMan(www.medresman.org)

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

In this study a standardized data collection and management system was used: case record form+Internet based EDC system. The Internet based electronic data collection and management system (EDC) uses the clinical trial public management platform ResMan (www.medresman. org)

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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