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Clinical study of heat-sensitive moxibustion to reduce drug craving in methamphetamine users : a randomized controlled trial

注册号：

Registration number：

ITMCTR2025000539

最近更新日期：

Date of Last Refreshed on：

2025-03-17

注册时间：

Date of Registration：

2025-03-17

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

热敏灸减轻冰毒吸食者毒瘾渴求的随机对照临床研究

Public title：

Clinical study of heat-sensitive moxibustion to reduce drug craving in methamphetamine users : a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

变频艾灸得气智能化关键技术与装备研发及其示范应用

Scientific title：

Research and development of intelligent key technology and equipment of variable frequency moxibustion for obtaining gas and its demonstration application

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：

陈青红

研究负责人：

谢丁一,陈日新

Applicant：

Qinghong Chen

Study leader：

Dingyi Xie.Rixin Chen

申请注册联系人电话：

Applicant telephone：

+86 15879036031

研究负责人电话：

Study leader's telephone：

+86 13970850489

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：

1208223929@qq.com

研究负责人电子邮件：

Study leader's E-mail：

281999814@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：

江西省南昌市西湖区抚生路666号江西中医药大学附属医院西湖院区

研究负责人通讯地址：

江西省南昌市西湖区抚生路666号江西中医药大学附属医院西湖院区

Applicant address：

The Affiliated Hospital of Jiangxi University of CM No.666 Fusheng Road NanChang City. Jiangxi Province .China

Study leader's address：

The Affiliated Hospital of Jiangxi University of CM No.666 Fusheng Road NanChang City. Jiangxi Province .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：

江西中医药大学附属医院

Applicant's institution：

The Affiliated Hospital of Jiangxi University of CM

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：

JZFYLL20241216134

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：

江西中医药大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of The Affiliated Hospital of Jiangxi University of CM

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/30 0:00:00

伦理委员会联系人：

熊明奕

Contact Name of the ethic committee：

Mingyi Xiong

伦理委员会联系地址：

江西省南昌市西湖区抚生路666号江西中医药大学附属医院西湖院区

Contact Address of the ethic committee：

The Affiliated Hospital of Jiangxi University of CM No.666 Fusheng Road NanChang City. Jiangxi Province .China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 079186361455

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zyykyk@126.com

研究实施负责（组长）单位：

江西中医药大学附属医院

Primary sponsor：

The Affiliated Hospital of Jiangxi University of CM

研究实施负责（组长）单位地址：

江西省南昌市西湖区抚生路666号江西中医药大学附属医院西湖院区

Primary sponsor's address：

The Affiliated Hospital of Jiangxi University of CM No.666 Fusheng Road NanChang City. Jiangxi Province .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)：

江西省

市(区县)：

南昌市

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

江西中医药大学附属医院

具体地址：

江西省南昌市西湖区抚生路666号江西中医药大学附属医院西湖院区

Institution
hospital：

The Affiliated Hospital of Jiangxi University of CM

Address：

The Affiliated Hospital of Jiangxi University of CM No.666 Fusheng Road NanChang City. Jiangxi Province .China

经费或物资来源：

江西省科技厅

Source(s) of funding：

Science and Technology Department of Jiangxi Province

研究疾病：

冰毒毒瘾渴求

研究疾病代码：

Target disease：

Methamphetamine addiction cravings

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：

团队前期通过艾灸得气技术干预，采用睡眠脑电检测、视觉模拟量表(visual analog scale, VAS)、汉密尔顿焦虑量表（Hamilton Anxiety Scale, HAMA）、汉密尔顿抑郁量表(Hamilton Depression Scale, HAMD)、匹兹堡睡眠质量指数（Pittsburgh sleep quality index, PSQI）评分及近红外脑功能成像（functional near-infrared spectroscopy，fNIRS）技术开展了热敏灸戒毒的初步研究，结果提示热敏灸可有效减轻冰毒吸食者的毒瘾渴求，且能改善其睡眠质量、焦虑、抑郁症状。但此研究为初步探索，尚缺乏严谨的临床随机对照试验来进一步验证其疗效及安全性。为了推动这一领域的科学发展，确保研究结果的可靠性和实用性，有必要开展更为深入和系统的临床研究。因此，本研究拟进一步开展随机对照试验，采用热敏灸机器人精准施灸技术，通过VAS、fNIRs、PSQI、HAMA、HAMD对毒瘾渴求、负性情绪、睡眠质量进行评估，证实热敏灸减轻冰毒吸食者毒瘾渴求的有效性，为灸法戒毒提供新的科研依据，为戒毒新型中医设备的研发提供科学思路，具有重要的学术价值与应用价值。

Objectives of Study：

The research team conducted an early-stage intervention using heat-sensitive moxibustion. Sleep EEG detection visual analog scale (VAS) Hamilton Anxiety Scale (HAMA) Hamilton Depression Scale (HAMD) Pittsburgh Sleep Quality Index (PSQI) and functional near-infrared spectroscopy (fNIRS) were employed to conduct a preliminary study on the drug withdrawal effects of heat-sensitive moxibustion. The results suggest that heat-sensitive moxibustion can effectively reduce methamphetamine users' cravings for drugs and improve their sleep quality anxiety and depression symptoms. However this study is a preliminary exploration and there is still a lack of rigorous randomized controlled clinical trials to further verify its efficacy and safety. To promote scientific development in this field and ensure the reliability and practicality of the research findings it is necessary to conduct more in-depth and systematic clinical research. Therefore this study aims to further implement a randomized controlled trial utilizing precise moxibustion technology from a heat-sensitive moxibustion robot to evaluate drug addiction cravings negative emotions and sleep quality through VAS fNIRS PSQI HAMA and HAMD. This will confirm the effectiveness of heat-sensitive moxibustion in reducing drug addiction cravings among methamphetamine users and provide a new scientific basis for moxibustion-based drug withdrawal. It holds significant academic and application value to offer scientific insights for the research and development of new CM equipment for drug rehabilitation.

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符合美国精神障碍诊断与统计手册（DSM-V）中MA依赖的诊断标准；②年龄18～65岁；③受教育6年（含）以上；④治疗期间无其他药物或非药物治疗干预；⑤单纯吸食冰毒；⑥首次进强制戒毒所，有戒毒心理需求；⑦受试者自愿受试且能完成规定时间的热敏灸；⑧能正确表达得气感应；⑨已完成3个月的生理脱毒期，在试验过程中不解除出所；⑩神阙穴、膻中穴出现穴位热敏。

Inclusion criteria

① Meet the diagnostic criteria for MA dependence in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); ② Age 18-65 years old; (3) more than 6 years of education; (4) No other drug or non-drug therapeutic intervention during treatment; ⑤ simple use of methamphetamine; ⑥ First time into the compulsory drug rehabilitation center there is a psychological need for drug rehabilitation; ⑦ The subject is willing to be tested and can complete the prescribed time of heat-sensitive moxibustion; ⑧ can correctly express the qi sensation; ⑨ The 3-month physiological detoxification period has been completed and no detoxification has been completed during the test; ⑩ Shenque point and Danzhong point heat sensitivity.

排除标准：

①有需要服用药物的严重躯体或神经疾病，比如糖尿病、脑卒中、癫痫、外伤等；②患有精神障碍性疾病，如双相型障碍、精神分裂症等；③患有艾滋病、肺结核等传染性疾病；④过去5年除尼古丁、酒精以外的其他物质依赖；⑤妊娠或哺乳期者；⑥近1个月内接受过艾灸治疗；⑦同时参加其他临床研究者。

Exclusion criteria：

①A serious physical or neurological disease that requires medication such as diabetes stroke epilepsy trauma etc.; ② suffering from mental disorders such as bipolar disorder schizophrenia etc.; (3) suffering from infectious diseases such as AIDS and tuberculosis; Dependence on substances other than nicotine and alcohol in the past 5 years; (5) Pregnant or lactating; ⑥ Received moxibustion treatment in the past 1 month; ⑦ Participate in other clinical investigators at the same time.

研究实施时间：

Study execute time：

从From 2025-04-30

至To      2025-12-29

征募观察对象时间：

Recruiting time：

从From 2025-05-06

至To      2025-11-30

干预措施：

Interventions：

组别：

热敏灸组

样本量：

39

Group：

Heat sensitive moxibustion group

Sample size：

干预措施：

采用热敏灸机器人在神阙穴、膻中穴区以特定速率反复移动，当出现得气感应时，令机器人灸头的运行停顿，选择雀啄灸模式，施灸时灸头下限距离皮肤表面6cm左右，并在下限停留3s，上限距离皮肤表面12cm左右，并停留1s。每次施灸60min，每天1次，每周3次，共施灸4周。

干预措施代码：

Intervention：

The heat sensitive moxibustion robot was used to move repeatedly at a specific rate in Shenque and Danzhong points. When Deqi sensation occurred the operation of the robot moxibustion head was stopped. The fink-pecking moxibustion mode was selected. Moxibustion was applied for 60 minutes each time once a day 3 times a week for 4 weeks.

Intervention code：

组别：

假艾灸组

样本量：

39

Group：

false moxibustion group

Sample size：

干预措施：

采用热敏灸机器人在神阙穴、膻中穴区以特定速率反复移动，灸温以患者觉表面微热为度，选择雀啄灸模式，施灸时灸头下限距离皮肤表面10cm，并在下限停留3s，上限距离皮肤表面20cm左右，并停留1s。每次施灸60min，每天1次，每周3次，共施灸4周。

干预措施代码：

Intervention：

The heat sensitive moxibustion robot was used to move repeatedly at a specific rate in Shenque and Shanzhong points. The moxibustion temperature was determined by the slight heat on the patient's surface. The fin-pecking moxibustion mode was selected, and moxibustion was applied for 60min each time, once a day, 3 times a week, for a total of 4 weeks.

Intervention code：

样本总量 Total sample size ： 78

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江西省

市(区县)：

南昌市

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

江西中医药大学附属医院

单位级别：

三级甲等

Institution/hospital：

The Affiliated Hospital of Jiangxi University of CM

Level of the institution：

Grade 3A hospital

测量指标：

Outcomes：

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：

灸中入睡效应的脑电评估

指标类型：

次要指标

Outcome：

Eeg evaluation of sleep effect in moxibustion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟量表评分

指标类型：

主要指标

Outcome：

Visual analog scale Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

艾灸得气评估

指标类型：

次要指标

Outcome：

Evaluation of Deqi in moxibustion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

近红外脑功能成像分析

指标类型：

次要指标

Outcome：

Analysis of near-infrared brain function imaging

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：

次要指标

Outcome：

Hamilton Depression Scale 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：

汉密尔顿焦虑量表评分

指标类型：

次要指标

Outcome：

Hamilton Anxiety Scale Score

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：

没有

组织：

Sample Name：

none

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
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）：

本试验采用随机分配方法，三个中心均匀贡献，每个中心由统计人员采用SPSS 27.0随机数字表，产生随机号，然后密封装入不透光的信封，符合纳入标准的患者进入研究时，按信封中的随机分组安排将患者纳入相应的组别进行处理 。

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

The experiment adopted random assignment method. Statisticians used SPSS 27.0 random number table to generate random numbers then sealed the envelope into an opaque envelope and divided the data into male and female pools with a male-to-female ratio of nearly 2:1. Then the three centers were stratified and randomly distributed according to gender to ensure that each center contributed evenly when patients meeting the inclusion criteria entered the study. Patients were included in the corresponding group for treatment according to the randomized arrangement in the envelope.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

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）：

无

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

None

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：

1.病例记录表：每个入选病例都必须完成研究资料报告表（CRF）。全部临床试验资料进行妥善保存和管理，临床观察结果采用第三者记录方法填写在统一印刷的病例观察表上。 2.建立数据库：根据方案及病例观察表规定的观察项目，采用Excel软件建立数据库，数据分别独立进行双人录入；数据核查，随机抽取10％的研究资料报告表人工检查。 3.资料保密与汇总：在研究完成之前，我们将对干预期的登记资料进行严格的保密管理，以确保数据的安全性和隐私保护。待研究结束后，我们将对全部资料进行汇总分析。

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

1. Case Record Form: Each enrolled case must complete the Research Data Report Form (CRF). All clinical trial data were properly preserved and managed and clinical observation results were recorded by third party on uniformly printed case observation forms. 2. Database establishment: According to the protocol and observation items specified in the case observation table Excel software was used to establish the database and the data were independently entered by two persons; Data check randomly selected 10% of the research data report form manual check. 3. Data confidentiality and summary: Before the completion of the study we will conduct strict confidentiality management of the registered data during the intervention period to ensure data security and privacy protection. After the study we will make a summary analysis of all the data.

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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