ChiCTR2400081002 版本V1.0 版本创建时间2024/02/20 11:37:32 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400081002 

最近更新日期：

Date of Last Refreshed on：

2024-02-20 11:37:27 

注册时间：

Date of Registration：

2024-02-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

火龙罐综合灸在GLP-1受体激动剂引起胃肠道反应的干预研究

Public title：

Effects on the intervention of fire-dragon pot in gastrointestinal reaction induced by GLP-1 receptor agonists

注册题目简写：

English Acronym：

研究课题的正式科学名称：

火龙罐综合灸在GLP-1受体激动剂引起胃肠道反应的干预研究

Scientific title：

Effects on the intervention of fire-dragon pot in gastrointestinal reaction induced by GLP-1 receptor agonists

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：

申婷婷 

研究负责人：

史倩云 

Applicant：

Tingting Shen 

Study leader：

Qianyun Shi 

申请注册联系人电话：

Applicant telephone：

+86 182 0341 0678

研究负责人电话：

Study leader's telephone：

+86 158 3419 5251

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：

651539702@qq.com

研究负责人电子邮件：

Study leader's E-mail：

596107048@qq.com

申请单位网址(自愿提供)：

Applicant 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：

山西省太原市杏花岭区府东街8号

研究负责人通讯地址：

山西省太原市杏花岭区府东街8号

Applicant address：

No.8, Fudong Street, Xinghualing District, Taiyuan City, Shanxi Province, China

Study leader's address：

No.8, Fudong Street, Xinghualing District, Taiyuan City, Shanxi 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：

山西中医药大学

Applicant's institution：

Shanxi University of Chinese Medicine

研究负责人所在单位：

山西省中西医结合医院

Affiliation of the Leader：

Shanxi Integrated Traditional Chinese and Western Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KYLL-2023-0105

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

山西省中西医结合医院

Name of the ethic committee：

Shanxi Integrated Traditional Chinese and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023-12-22 00:00:00

伦理委员会联系人：

王江

Contact Name of the ethic committee：

Jiang Wang

伦理委员会联系地址：

山西省太原市杏花岭区府东街8号

Contact Address of the ethic committee：

No.8, Fudong Street, Xinghualing District, Taiyuan City, Shanxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 351 215 0722

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：

山西省中西医结合医院

Primary sponsor：

Shanxi Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

山西省太原市杏花岭区府东街8号

Primary sponsor's address：

No.8, Fudong Street, Xinghualing District, Taiyuan City, Shanxi 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)：

山西

市(区县)：

太原

Country：

China

Province：

ShanXi

City：

TaiYuan

单位(医院)：

山西省中西医结合医院

具体地址：

山西省太原市杏花岭区府东街8号

Institution
hospital：

Shanxi Integrated Traditional Chinese and Western Medicine

Address：

No.8, Fudong Street, Xinghualing District, Taiyuan City, Shanxi Province, China

经费或物资来源：

火龙罐由厦门玄雕文化传播有限公司生产，批文号：20220831，中罐 艾条由蕲春华鼎生态艾业有限公司生产，规格：25*20mm 项目资金由山西省卫生健康委办公室

Source(s) of funding：

Fire dragon pot by xiamen xuan carving culture dissemination limited company production, approval number: 20220831, moderate Mugwort sticks produced by Herb Spring Huading Ecological Mugwort Industry Co., Ltd, specification: 25*20mm Project funding provided by the office of the Shanxi Provincial Health and Wellness Commission

Target disease：

Gastrointestinal reactions induced by GLP-1 receptor agonists

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

观察火龙罐综合灸对GLP-1受体激动剂引起胃肠道反应的治疗效果。  

Objectives of Study：

To observe the therapeutic effect of integrated moxibustion with fire dragon pot on gastrointestinal reactions induced by GLP-1 receptor agonists.

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2型糖尿病诊断标准者； ②符合胃肠道反应脾胃气虚的证型（患者应用GLP-1引起的胃肠道反应临床表现与胃脘痛脾胃气虚证型一致）； ③年龄大于18岁，小于75岁； ④签署知情同意书； ⑤BMI大于18.5者。

Inclusion criteria

① Meet the diagnostic criteria of type 2 diabetes mellitus; ② It is consistent with the syndrome type of spleen and stomach qi deficiency caused by gastrointestinal reaction (the clinical manifestations of gastrointestinal reaction caused by GLP-1 in patients are consistent with the syndrome type of spleen and stomach qi deficiency in stomach duct pain); ③ The age is more than 18 years old, less than 75 years old; ④ Sign informed consent; ⑤ BMI greater than 18.5.

排除标准：

①妊娠糖尿病患者及特殊类型糖尿病患者； ②严重心肝肾功能不全患者或其他原发性重大疾病者； ③近期有DM其他急性、慢性并发症（糖尿病酮症酸中毒、高渗性昏迷、糖尿病肾病、糖尿病视网膜病变等疾病）以及并发感染者； ④服用糖皮质激素和使用其他影响血糖的药物； ⑤患者有消化性溃疡、消化道肿瘤（或术后）、门静脉所致的食管胃底静脉曲张、胃食管反流症、消化道感染； ⑥精神智力障碍，不能清楚描述主观感受者； ⑦对艾条过敏者； ⑧皮肤粘膜破溃者。

Exclusion criteria：

① Gestational diabetes mellitus and special type diabetes mellitus; ② Patients with severe heart, liver and renal insufficiency or other major primary diseases; ③ Other acute and chronic complications of DM (diabetic ketoacidosis, hyperosmolar coma, diabetic nephropathy, diabetic retinopathy, etc.) and co-infected patients have recently been diagnosed; ④ Taking glucocorticoids and using other drugs that affect blood sugar; ⑤ The patient had peptic ulcer, digestive tract tumor (or postoperative), esophageal fundus varices caused by portal vein, gastroesophageal reflux disease, and digestive tract infection; ⑥ Mental and intellectual disabilities, unable to clearly describe subjective feelings; ⑦ Allergic to moxa sticks; ⑧ The skin mucosa ruptured.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-01 00:00:00 至 To 2025-03-31 00:00:00  

干预措施：

Interventions：

组别：

火龙罐综合灸组

样本量：

40

Group：

The Integrated Moxibustion with Fire Dragon Pot group

Sample size：

干预措施：

在常规治疗基础上应用火龙罐综合灸治疗，分腰背部、腹部及相应穴位，时间为30min。腰背部治疗：①提前准备合适罐体，嘱患者俯卧，充分暴露腰背部，涂抹适量艾草精油；②点燃火龙罐内艾柱，燃烧均匀后，捧起火龙罐并于腰背部适宜位置落罐；③通过揉、碾、推、按、点、摇等一系列手法，旋转、摇震罐体，使火龙罐充分作用于督脉、膀胱经，重点点揉肝俞、脾俞、胃俞等穴位。腹部治疗：①嘱患者调整体位，取仰卧位并充分暴露腹部，操作手法同上，操作时注意控制力度，并沿大肠形态走向，由左上腹推移至下腹，自上而下沿降结肠的外形轮廓匀速反复推动；②利用火龙罐“莲花瓣”刺激中脘、气海、关元、天枢，手法以按、点、压为主；③患者保持半卧位，选取双侧足三里，进行火龙罐综合灸，手法以点、灸为主，以患者有温热感且无灼痛感为度，时间为3~5min/穴。如发现患者出现皮肤发红、痛痒、心慌、面色苍白等症状，立即停止治疗，让患者卧床休息。④治疗过程中注意控制行罐的速度，动作宜轻柔，遵循先近后远的原则，并留意罐内温度，避免烫伤皮肤。每日行罐1次，连续5天后休息2天，7天为1个疗程，共2个疗程。

干预措施代码：

Intervention：

On the basis of conventional treatment, the application of dragon pot integrated moxibustion treatment, divided into the lumbar back, abdomen and the corresponding acupuncture points, the time for 30 min. lumbar back treatment: ① prepare the proper canister in advance, ask the patient to lie prone, fully expose the lumbar back, and apply an appropriate amount of mugwort oil; ② ignition of moxa columns in the fire dragon pot, burn evenly, hold up the fire dragon canister and the lumbar back in the appropriate position of the drop canisters; ③ through a series of techniques such as kneading, crushing, push, pressure, pointing, shaking, etc., rotating, shaking the canister to make the full effect of the ducal chi, the bladder meridian, focusing on kneading the liver yu, spleen yu, stomach yu and other points. Through a series of maneuvers, rotate and shake the jar to make the fire dragon jar fully act on the dushi meridian and bladder meridian, focusing on acupoints such as the liver, spleen and stomach. Abdominal treatment: ① ask the patient to adjust the position, take the supine position and fully expose the abdomen, the operation is the same as above, the operation of attention to controlling the strength, and along the large intestine form towards the left upper abdomen to the lower abdomen, top to bottom along the outline of the shape of the descending colon uniformly and repeatedly pushed; ② the use of fire cans, "Lotus Petal" stimulation in the epigastric, Qihai, Guanyuan, Tianshu ①The use of "lotus petals" to stimulate the middle epigastric region, Qihai, Guanyuan, Tianshu, mainly by pressing, pointing, pressing; ③Patients to maintain a semi-recumbent position, select bilateral foot Sanli, the Dragon jar integrated moxibustion, the technique to point, moxibustion, in order to the patient to have a sense of warmth and no burning pain as the degree of time for 3 ~ 5min / point. If the patient is found to have symptoms such as reddening of the skin, pain and itching, panic, pallor, etc., immediately stop the treatment and let the patient rest in bed. ④ During the treatment, pay attention to control the speed of traveling cans, the action should be gentle, follow the principle of first near and then far, and pay attention to the temperature of the cans to avoid scalding the skin. Do not burn the skin. Do the canning once a day, rest for 2 days after 5 consecutive days, 7 days for a course of treatment, a total of 2 courses of treatment.

Intervention code：

组别：

常规护理组

样本量：

40

Group：

Routine care group

Sample size：

干预措施：

①情志护理：对患者采用心理疏导，认真倾听患者关于病情的述说，帮助其缓解患者紧张情绪，并给予耐心解释，让患者可以了解相关知识。②饮食调护：让患者遵照糖尿病饮食并低脂少渣饮食，不吃纯粗粮、生冷瓜果、油腻及刺激性食物。③病情观察：观察患者是否有腹痛、腹泻、腹胀、便秘、黏液便、便后窘迫感等消化道症状以及是否有头昏、心烦、失眠、焦虑、抑郁等症状。④生活起居：注意控制好房内温湿度，保持开窗通风，确保环境舒适；同时注意避免腹部受寒。⑤用药护理：遵医嘱正确给药，必要时可加用缓解胃肠道症状的药物对症治疗。

干预措施代码：

Intervention：

①Emotional care: adopt psychological counseling for patients, listen carefully to patients about their conditions, help them relieve their tension, and give patient explanations, so that patients can understand the relevant knowledge. ② Dietary care: let the patient follow the diabetic diet and low-fat and low-slag diet, do not eat pure coarse grains, cold fruits and vegetables, greasy and stimulating food. ③ Observation: Observe whether the patient has digestive symptoms such as abdominal pain, diarrhea, bloating, constipation, mucus stools, post-stool embarrassment, etc. as well as symptoms such as dizziness, heartburn, insomnia, anxiety and depression. ④Living and living: pay attention to control the temperature and humidity in the room, keep the windows open and ventilate the room to ensure a comfortable environment; at the same time, pay attention to avoiding the abdomen from being cold. ⑤Medication care: follow the doctor's instructions to give the correct medication, if necessary, can be added to relieve gastrointestinal symptoms of the drug symptomatic treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

  

Country：

China 

Province：

Shanxi 

City：

 

单位(医院)：

山西省中西医结合医院 

单位级别：

三甲 

Institution
hospital：

Shanxi Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

胃肠疾病中医证候评分表

指标类型：

主要指标

Outcome：

Gastrointestinal Diseases Chinese Medicine Symptoms Scoring Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃肠功能激素水平

指标类型：

次要指标

Outcome：

Hormone levels for gastrointestinal function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血细胞分析、肝功能（ALT、AST）、肾功能（BUN、Cr）

指标类型：

附加指标

Outcome：

Blood cell analysis, liver function (ALT, AST), kidney function (BUN, Cr)

Type：

Additional 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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究由李梦薇从随机数字表中随机抽取一行数字，奇数入观察组，偶数入对照组。符合纳入排除标准的患者按照出现胃肠道反应的时间及对应数字表中的数字分为对照组和实验组。

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

In this study, Mengwei Li will randomly select a row of numbers from a random number table. Odd numbers will be included in the observation group and even numbers will be included in the control group. Patients who meet the inclusion and exclusion criteria will be divided into control group and experimental group according to the time of gastrointestinal reactions and the numbers in the corresponding numerical table.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

科室的医务人员不清楚患者的分组情况，操作护士只知道给予患者火龙罐综合灸并不清楚患者的分组情况。数据收集人员不清楚患者的分组情况。

Blinding：

The medical staff of the department was not aware of the grouping of patients, and the operating nurse only knew to give the patients integrated moxibustion with fire dragon pot and was not aware of the grouping of patients. The data collector was not aware of the grouping of patients.

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）：

时间：2026-01-01，方式：公共管理平台ResMan

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

Publication time: 2026-01-01, publication method: public management platform ResMan

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：

数据由经过培训的研究生统一收集，两名研究生核对后入录电脑Excel表格。后使用公共管理平台ResMan 进行数据管理。

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

The data were collected by the trained graduate students and checked by two graduate students before being recorded in the computer Excel table. After that, the public management platform ResMan is used for data management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-02-20 11:37:27