基于口腔微生物组学评价的 改良长蛇灸治疗阈下抑郁临床研究

注册号:

Registration number:

ITMCTR2024000453

最近更新日期:

Date of Last Refreshed on:

2024-09-18

注册时间:

Date of Registration:

2024-09-18

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于口腔微生物组学评价的 改良长蛇灸治疗阈下抑郁临床研究

Public title:

Clinical effect of Long-snake-like moxibustion on subthreshold depression and its impact on oral microbiome: A randomized clinical trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于口腔微生物组学评价的 改良长蛇灸治疗阈下抑郁临床研究

Scientific title:

Clinical effect of Long-snake-like moxibustion on subthreshold depression and its impact on oral microbiome: A randomized clinical trial

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:

韩成宇

研究负责人:

马婷婷

Applicant:

Chengyu Han

Study leader:

Tingting Ma

申请注册联系人电话:

Applicant telephone:

+86 18863486856

研究负责人电话:

Study leader's telephone:

+86 13550086707

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:

2326097541@qq.com

研究负责人电子邮件:

Study leader's E-mail:

6080934@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:

四川省成都市金牛区十二桥路37号

研究负责人通讯地址:

四川省成都市金牛区十二桥路39号

Applicant address:

37 Shierqiao Road, Jinniu District, Chengdu, Sichuan

Study leader's address:

39 Shierqiao Road Jinniu District Chengdu Sichuan

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:

成都中医药大学

Applicant's institution:

Chengdu University of Traditional Chinese Medicine

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:

2024KL-115

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:

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee:

The Ethics Committee of Hospital of Chengdu University of TCM

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/27 0:00:00

伦理委员会联系人:

王艳桥

Contact Name of the ethic committee:

Yanqiao Wang

伦理委员会联系地址:

四川省成都市金牛区十二桥路39号

Contact Address of the ethic committee:

39 Shierqiao Road Jinniu District Chengdu Sichuan

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 28 8778 3142

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ethicscd@126.com

研究实施负责(组长)单位:

成都中医药大学附属医院

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路39号

Primary sponsor's address:

39 Shierqiao Road, Jinniu District, Chengdu, Sichuan

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

四川省成都市金牛区十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Shierqiao Road, Jinniu District, Chengdu, Sichuan

经费或物资来源:

四川省中医药管理局

Source(s) of funding:

Sichuan Provincial Administration of Traditional Chinese Medicine

研究疾病:

阈下抑郁

研究疾病代码:

Target disease:

Subthreshold depression

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:

本研究以SD患者为研究对象,以健康人和抑郁症患者为对照,以改良长蛇灸结合针刺为干预措施,借助相关量表评价和口腔微生物组学方法,旨在评估阈下抑郁改变的靶关键口腔菌群以及观察改良长蛇灸结合针刺干预SD的临床效应以及治疗前后的口腔菌群结构差异。

Objectives of Study:

To explore the characteristics of oral microorganisms in subthreshold depression(SD) patients, and clarify the therapeutic effect of Long-snake-like moxibustion based on oral microbiome.

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.健康人: (1)符合世界卫生组织提出的健康人的标准 (2)年龄须在18岁-65岁; (2)尚未确诊任何器质性疾病; (3)汉密尔顿抑郁量表(HAMD-17)评分:HAMD-17总分<7分; (4)流调中心用抑郁自评量表(CES-D)评分:CES-D评分<16分; (5)自愿参加本研究并签署知情同意书; (6)近一月来未参与其他可能影响结果的科研项目。 2.阈下抑郁患者 (1)符合SD的诊断标准; (2)年龄在18-65岁; (3)汉密尔顿抑郁量表(HAMD-17)评分:7分≤HAMD-17总分<17分; (4)流调中心用抑郁自评量表(CES-D)评分:CES-D评分≥16分; (5)自愿参加本研究并签署知情同意书; (6)近一月来未参与其他可能影响结果的科研项目。 3.抑郁症患者: (1)符合抑郁症诊断标准; (2)年龄在18-65岁; (3)汉密尔顿抑郁量表(HAMD-17)评分:HAMD-17总分≥17分; (4)流调中心用抑郁自评量表(CES-D)评分:CES-D评分≥16分; (5)自愿参加本研究并签署知情同意书; (6)近一月来未参与其他可能影响结果的科研项目。

Inclusion criteria

1. Healthy people: (1) Meet the World Health Organisation's criteria for a healthy person (2) Aged 18-65 years old; (2) No organic disease has been diagnosed; (3) Hamilton Depression Scale (HAMD-17) score: HAMD-17 total score <7; (4) Center for Epidemiologic Studies Depression Scale (CES-D): CES-D score <16; (5) Voluntarily participate in this study and sign an informed consent form; (6) Have not been involved in other research projects in the last month that could affect the results. 2. Patients with subthreshold depression (1) Meet the diagnostic criteria of SD; (2) Aged 18-65 years old ; (3) Hamilton Depression Scale (HAMD-17) score: 7 ≤ HAMD-17 total score <17; (4) Center for Epidemiologic Studies Depression scale (CES-D): CES-D score ≥ 16; (5) Voluntarily participate in this study and sign an informed consent form; (6) Have not been involved in other research projects in the last month that could affect the results. 3. Patients with depression: (1) Meet the diagnostic criteria of depression; (2) Aged 18-65 years old ; (3) Hamilton Depression Scale (HAMD-17) score: HAMD-17 total score ≥ 17; (4) Center for Epidemiologic Studies Depression Scale(CES-D): ≥16 on the CES-D; (5) Voluntarily participate in this study and sign an informed consent form; (6) Have not been involved in other research projects in the last month that could affect the results.

排除标准:

(1)意识不清,不能表达主观不适症状,精神病患者; (2)进展性恶性肿瘤或其他严重消耗性疾病,易合并感染及出血者; (3)合并心血管、肝、肾、消化、造血系统等原发性疾病者; (4)孕妇及哺乳期妇女; (5)有口臭、龋齿(牙釉质或牙本质病变的白点病变)或牙周病,有口腔粘膜疾病的临床症状; (6)佩戴可移动或固定的假体器具; (7)在过去一个月内食用抗生素和/或益生菌制剂。

Exclusion criteria:

(1) Those who are unconscious or unable to express subjective symptoms of discomfort or suffer from mental illness; (2) Those with progressive malignant tumors or other severe consumptive diseases, easily suffer from infections and bleeding; (3) Those with cardiovascular, or hepatic, or renal, or digestive, or hematopoietic system and other primary diseases; (4) Pregnant and lactating women; (5) Those who have bad breath dental caries (white spot lesions of enamel or dentin lesions) , or periodontal disease,or clinical symptoms of oral mucosal diseases; (6) Wearing removable or fixed prosthetic appliances; (7) Consumption of antibiotic and/or probiotic preparations within the past month.

研究实施时间:

Study execute time:

From 2024-08-01

To      2026-07-31

征募观察对象时间:

Recruiting time:

From 2024-09-20

To      2026-07-31

干预措施:

Interventions:

组别:

常规针刺组

样本量:

33

Group:

Acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

认知行为疗法组

样本量:

33

Group:

Cognitive behavioral therapy group

Sample size:

干预措施:

认知行为疗法

干预措施代码:

Intervention:

Cognitive behavioral therapy

Intervention code:

组别:

长蛇灸合并针刺组

样本量:

33

Group:

Long-snake-like moxibustion plus acupuncture group

Sample size:

干预措施:

改良长蛇灸60分钟+针刺

干预措施代码:

Intervention:

60-minute Long-snake-like moxibustion plus acupuncture

Intervention code:

样本总量 Total sample size : 99

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

SIichuan

City:

单位(医院):

成都中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

中国版压力知觉量表

指标类型:

次要指标

Outcome:

Chinese 14-Item Perceived Stress Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

主要指标

Outcome:

HAMD-17

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者治疗期待评价

指标类型:

次要指标

Outcome:

Patient Treatment Expectation Assessment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简版生活质量量表

指标类型:

次要指标

Outcome:

Short Form 12-item Health Survey

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

流调中心用抑郁量表

指标类型:

次要指标

Outcome:

Center for Epidemiologic Studies Depression Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标

Outcome:

Pittsburgh sleep quality index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

随访第6月抑郁症发生率

指标类型:

次要指标

Outcome:

Incidence of depression at the 6-month follow-up

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:

唾液

组织:

Sample Name:

Saliva

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:

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):

随机方法采用区组随机,区组长度为9,根据区组长度进行排列组合以确定各区组内受试者顺序,由电脑生成的随机数字排列区组,根据区组顺序将99例受试者按1:1:1的比例依次随机分入三组(A组、B组和C组)。

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

The randomization procedure is block randomization with a block length of 9. The arrangement and combination of subjects within each block are determined based on the block length. The random numbers generated by the computer are arranged in the block. According to the sequence of the block 99 subjects are randomly divided into three groups in the ratio of 1:1:1 ( Group A Group B and Group C ).

盲法:

本研究仅对数据收集、疗效评价及数据统计人员设盲,即不参与具体治疗过程,不知晓分组情况。

Blinding:

In this study, the personnel responsible for data collection, efficacy evaluation, and data statistics are blinded. They do not participate in the treatment process and do not know the group allocation.

是否共享原始数据:

IPD sharing:

Yes

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):

联系负责人,邮件获得。

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

Contact with the study leader through e-mail

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+基于excel的电子数据采集

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

Case Record Form+electronic data collection based on Excel

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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