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推拿敷贴配合饮食管理治疗婴幼儿迁慢性腹泻的推广示范研究
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注册号：

Registration number：

 ChiCTR2400082822 

最近更新日期：

Date of Last Refreshed on：

 2024-04-09 10:04:42 

注册时间：

Date of Registration：

 2024-04-09 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

推拿敷贴配合饮食管理治疗婴幼儿迁慢性腹泻的推广示范研究

Public title：

Promotion and demonstration study on the combination of tuina patches and dietary management in the treatment of chronic diarrhea in infants and young children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

推拿敷贴配合饮食管理治疗婴幼儿迁慢性腹泻的推广示范研究

Scientific title：

Promotion and demonstration study on the combination of tuina patches and dietary management in the treatment of chronic diarrhea in infants and young children

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：

杨兵宾 

研究负责人：

郭凯 

Applicant：

Yang Bingbin 

Study leader：

Guo Kai 

申请注册联系人电话：

Applicant telephone：

 +86 157 1135 8716

研究负责人电话：

Study leader's
telephone：

+86 136 8104 3781

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：

 yangbingbin7254@163.com

研究负责人电子邮件：

Study leader's E-mail：

 liangweilong1208@126.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：

北京市朝阳区中环南路6号

研究负责人通讯地址：

北京市朝阳区中环南路6号

Applicant address：

6 Zhonghuan South Road, Chaoyang District, Beijing

Study leader's address：

6 Zhonghuan South Road, Chaoyang 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：

中国中医科学院望京医院

Applicant's institution：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

研究负责人所在单位：

中国中医科学院望京医院

Affiliation of the Leader：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 WJEC-KT-2022-033-P002

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：

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-07-06 00:00:00

伦理委员会联系人：

王浩

Contact Name of the ethic committee：

Wang Hao

伦理委员会联系地址：

北京市朝阳区中环南路6号

Contact Address of the ethic committee：

6 Zhonghuan South Road, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8473 9681

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：

中国中医科学院望京医院

Primary sponsor：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市朝阳区中环南路6号

Primary sponsor's address：

6 Zhonghuan South Road, Chaoyang 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)：

朝阳区

Country：

China

Province：

Beijing

City：

Chaoyang District

单位(医院)：

中国中医科学院望京医院

具体地址：

北京市朝阳区中环南路6号

Institution
hospital：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

Address：

6 Zhonghuan South Road, Chaoyang District, Beijing

经费或物资来源：

首都卫生发展科研专项

Source(s) of funding：

Capital Health Development Research Special Project

研究疾病：

婴幼儿迁慢性腹泻  

Target disease：

Chronic diarrhea in infants and young children

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1 总体目标 通过小儿推拿敷贴配合饮食管理治疗婴幼儿迁慢性腹泻的综合方案在北京基层社区医院进行的临床应用及推广，研究该项技术在临床推广应用的有效模式及可行性、疗效的稳定性、推广应用的影响因素，临床的可推广性及卫生经济与社会效益。 2 具体目标 （1）选取 5 家社区医院开展推广，每家社区医院采用该项疗法治疗迁慢性腹泻患儿 30 例。 （2）通过社区医师采用该项技术治愈迁慢性腹泻婴幼儿的病例数、疗效分析、以及社区医师、患儿及家长对该项技术的安全性、有效性、经济性、稳定性等不同维度的评价，分析该项技术的推广成效。 （3）通过汇总社区医师医疗信息调查问卷、患儿及家长依从性、满意度调查问卷，分析影响该项技术社区家庭推广应用的相关因素。 （4）通过推广应用过程带来的卫生经济及社会效益，评价该项技术的推广成效，初步建立该项技术社区推广模式，成立推广示范单位。待本项技术在北京社区医院进行有效开展并积累丰富的经验后，可向北京市其他医院及全国各个省、市、自治区基层医院进行技术推广。  

Objectives of Study：

1 Overall Objective Through the clinical application and promotion of the comprehensive program of pediatric massage application combined with diet management in the treatment of chronic infantile diarrhea in Beijing primary community hospitals, the effective mode and feasibility of the clinical application of this technology, the stability of the curative effect, the influencing factors of the promotion and application, the clinical popularization and the health economic and social benefits were studied. 2 Targets (1) Five community hospitals were selected for the promotion, and 30 children with chronic diarrhea were treated with this therapy in each community hospital. (2) To analyze the promotion effect of the technology by analyzing the number of cases and efficacy of the technology used by community doctors to cure infants with chronic diarrhea, and the evaluation of different dimensions of the technology by community doctors, children and parents, such as safety, effectiveness, economy and stability. (3) By summarizing the medical information questionnaires of community physicians, compliance and satisfaction questionnaires of children and their parents, the related factors affecting the promotion and application of this technology in community families were analyzed. (4) To evaluate the promotion effect of this technology through the health economic and social benefits brought by the application process, and to establish the community promotion model of this technology, and to set up a promotion demonstration unit. After this technology has been effectively carried out in Beijing community hospitals and rich experience has been accumulated, it can be promoted to other hospitals in Beijing and primary hospitals in all provinces, cities and autonomous regions of China.

药物成份或治疗方案详述：

（1）临床病例治疗方案：推拿、中药敷贴、饮食管理。 ①推拿 每日1次，每次30分钟。推拿手法：脾经：拇指末节螺纹面或拇指桡侧边缘。补脾经：旋推拇指末节螺纹面或将患儿拇指屈曲，循拇指桡侧边缘向掌根方向直推100次。大肠经：食指的桡侧缘，自食指尖至虎口成一直线。补大肠：以拇指桡侧或指面在穴位上作直线推法，自指尖推向虎口100次。小肠经：小指尺侧边缘，自指尖到指根成一直线。清小肠：由指根向指尖直推50次。板门：手掌大鱼际平面。揉板门：顺时针或逆时针指端揉50次。内八卦：手掌面以内劳宫为圆心，从内劳宫至中指根横纹约2/3为半径的圆周上，运内八卦：用运法顺时针方向掐运50次。揉脐：中指端揉50次。逆时针为补，顺时针为泻。天枢：脐旁2寸。顺时针或逆时针食指和无名指指端揉50次。揉天枢和揉脐可同时进行。揉腹：掌心对准肚脐，掌面逆时针徐徐用力，3-5分钟。七节骨：第四腰椎与尾骨端成直线。推上七节骨：用拇指桡侧面或食、中指自下而上直推100次。龟尾：尾椎骨端与肛门之间。揉龟尾：中指端顺时针揉100次，顺时针环揉肛周100次。捏脊：穴位位于脊柱两侧。先在背部撒上滑石粉，轻轻按摩几遍，使皮肤润滑，肌肉放松，自骶尾部向上提捏至大椎，每捏3下向上提1次，共捏5次。 ②中药敷贴 根据中医辨证分型属于脾虚泻者予以健脾止泻散外敷-采用我院四川新绿色药业科技发展股份有限公司生产的中药配方颗粒调和上海黄酒制成药饼,直径为2cm,厚0.5cm,置于医用胶贴中央,敷于脐部、双侧脾腧。每日1次,每次4-6h,冬春季每次可适当延长。治则:健脾益气,温阳止泻，基本方：健脾止泻散(太子参10g，茯苓10g，白术10g，扁豆10g，陈皮10g，山药10g，甘草6g，莲子肉10g，砂仁10g，薏苡仁15g，桔梗6g，石榴皮10g，檀香6g等)。 ③饮食管理 补液：推荐使用自制补液米汤500ml米汤兑半啤酒盖盐（约1.75g），间隔5-10分钟予患儿口服一次，尽可能多的补充液体，腹泻次数减少后可逐渐减少每日摄入量。 饮食方面：母乳喂养者继续母乳喂养，暂停辅食，母乳喂养的母亲应注意进食清淡易消化的饮食。母乳喂养前需喂服米汤水至少20ml，两次母乳间多次补充米汤水加盐溶液；采用人工喂养的患儿则可采用等量米汤稀释牛奶或配方奶粉的方式，最初稀释比例为1:1，然后根据病情的好转情况，逐渐由1:2、1:3添加到正常浓度，使用腹泻奶粉或深度水解蛋白奶粉者亦可按照此比例换回正常奶粉；每天加喂1-2次大米糊，已使用米粉者换成自制大米糊，米糊里不放糖；6个月以上小儿可选用较稠的大米粥或烂面条，内可加少量新鲜蔬菜、肉末。水果类可使用温和的苹果、桃等，做成新鲜的果泥少量食用，不可吃西瓜、香蕉、梨、火龙果、猕猴桃等寒凉水果，切忌饮用果汁；双糖不耐受者，由于不同程度的原发或继发双糖酶缺乏，食用含双糖包括蔗糖，乳糖，麦芽糖饮食可使腹泻加重，应用去双糖饮食；过敏性腹泻如果排除双糖不耐受者，应考虑是否对蛋白质过敏，如牛奶，应改用其他饮食。 （2）入组医生：迁慢性腹泻理论知识培训；推拿、敷贴及饮食管理治疗迁慢性腹泻的技术培训。 

Description for medicine or protocol of treatment in detail：

(1)Treatment plan for clinical cases: massage, traditional Chinese medicine application, diet management. ① Tuina Once a day for 30 minutes each time. Massage technique: Spleen meridian: the threaded surface of the distal segment of the thumb or the radial edge of the thumb. Bu Pi Jing: Rotate and push the threaded surface of the distal segment of the thumb or bend the thumb of the patient, and push it 100 times along the radial edge of the thumb towards the palm root direction. Large intestine meridian: The radial edge of the index finger forms a straight line from the tip of the index finger to the mouth of the tiger. Supplementing the large intestine: Use the radial or fingertip of the thumb to perform a straight line pushing method on the acupoint, pushing it 100 times from the fingertip towards the tiger's mouth. Small intestine meridian: The edge of the ulnar side of the little finger forms a straight line from the fingertip to the root of the finger. Clear the small intestine: Push 50 times from the root of the finger to the tip of the finger. Plate door: flat surface of the palm's greater thenar. Rubbing the door: Rub the fingertips clockwise or counterclockwise 50 times. Inner Bagua: The inner palace of labor on the palm of the hand is the center of the circle, with a radius of about 2/3 of the horizontal pattern from the inner palace of labor to the root of the middle finger. Exercise the inner Bagua: Use the movement method to pinch clockwise 50 times. Rub the navel: Rub the middle finger 50 times. Counterclockwise for replenishment, clockwise for diarrhea. Tianshu: 2 inches beside the navel. Rub the fingertips of the index and ring fingers clockwise or counterclockwise 50 times. Rubbing the Tianshu and navel can be done simultaneously. Rubbing the abdomen: Align the palm with the navel, and slowly apply force counterclockwise on the palm for 3-5 minutes. Seven section bone: The fourth lumbar vertebra is in a straight line with the end of the coccyx. Push up the seven bones: Use the radial side of the thumb or the index and middle fingers to push from bottom to top 100 times. Tail of the penis: Between the end of the coccyx and the anus. Rubbing turtle tail: Rub the middle finger clockwise 100 times, and rub the anal area clockwise 100 times. Spinal compression: Acupoints are located on both sides of the spine. First, sprinkle talcum powder on the back, gently massage several times to lubricate the skin and relax the muscles. Lift and pinch from the sacral tail up to the greater vertebrae, once every 3 times, for a total of 5 times. ② Traditional Chinese medicine patches According to the traditional Chinese medicine syndrome differentiation, patients with spleen deficiency and diarrhea should be treated with Jianpi Zhixie Powder for external application. The traditional Chinese medicine formula particles produced by Sichuan New Green Pharmaceutical Technology Development Co., Ltd. and mixed with Shanghai Huangjiu are used to make medicinal cakes, with a diameter of 2cm and a thickness of 0.5cm. They are placed in the center of a medical adhesive and applied to the navel and bilateral spleen acupoints. Once a day, 4-6 hours each time, and each time can be appropriately extended in winter and spring. Treatment principles: invigorate the spleen and nourish qi, warm yang and stop diarrhea. Basic formula: invigorate the spleen and stop diarrhea powder (10g of Radix Pseudostellariae, 10g of Poria cocos, 10g of Atractylodes macrocephala, 10g of Leng Dou, 10g of Chenpi, 10g of Yam, 6g of Glycyrrhiza uralensis, 10g of Lotus Seed Meat, 10g of Sandalwood, 15g of Coix seed, 6g of Platycodon grandiflorus, 10g of Pomegranate Peel, 6g of Sandalwood, etc.). ③ Dietary management Fluid replacement: It is recommended to use homemade 500ml of rice soup mixed with half beer and salt (about 1.75g) for fluid replacement. The patient should take it orally every 5-10 minutes and try to replenish as much fluid as possible. After reducing the frequency of diarrhea, the daily intake can be gradually reduced. In terms of diet: Breastfed individuals should continue breastfeeding and suspend complementary feeding. Mothers who breastfeed should pay attention to eating a light and easily digestible diet. Before breastfeeding, it is necessary to feed at least 20ml of rice soup, and supplement the rice soup with salt solution multiple times between two rounds of breastfeeding; Children who are fed artificially can use an equal amount of rice soup to dilute milk or formula milk. The initial dilution ratio is 1:1, and then gradually increase from 1:2 to 1:3 according to the improvement of the condition to the normal concentration. Those who use diarrhea milk powder or deeply hydrolyzed protein milk powder can also switch back to normal milk powder according to this ratio; Add rice paste 1-2 times a day, and those who have used Rice noodles will change to homemade rice paste, without sugar in the rice paste; Children over 6 months old can choose thicker rice porridge or rotten noodles with a small amount of fresh vegetables and minced meat. Mild apples, peaches, and other fruits can be used to make fresh puree and consumed in small amounts. Cold fruits such as watermelons, bananas, pears, dragon fruit, kiwifruit, etc. should not be eaten. It is important to avoid drinking fruit juice; Individuals with disaccharide intolerance, due to varying degrees of primary or secondary disaccharide enzyme deficiency, consuming a diet containing disaccharides such as sucrose, lactose, and maltose can exacerbate diarrhea. Therefore, a disaccharide diet should be used; If excluding individuals with disaccharide intolerance, allergic diarrhea should consider whether they are allergic to proteins, such as milk, and switch to other diets. (2)Enrolled doctors: training on theoretical knowledge of chronic diarrhea; Technical training of massage, application and diet management in the treatment of chronic diarrhea. 

纳入标准：

Inclusion criteria

排除标准：

（1）临床病例排除标准： ①新生儿、高热、重度脱水、全身中毒症状严重者； ②细菌性痢疾、阿米巴痢疾、伤寒等疾病； ③脐部或周围皮肤有皮疹或皮肤破损者； ④正在使用其他临床实验药物者。 （2）临床医生排除标准： ①工作岗位不稳定或工作时间不固定，无法保证本项目培训和临床病例收集者； ②缺乏耐心，无法胜任小儿推拿工作及科研工作者。

Exclusion criteria：

(1) Exclusion criteria of clinical cases: ① Neonates, high fever, severe dehydration, and severe systemic poisoning symptoms; ② Bacillary dysentery, amebic dysentery, typhoid and other diseases; ③ Skin rash or skin damage on the umbilicus or surrounding skin; ④ Those who are using other clinical experimental drugs. (2) Clinician exclusion criteria: ① The job position is unstable or the working hours are not fixed, which cannot guarantee the training and clinical case collection of this project; ② Lack of patience, unable to be competent for pediatric massage work and scientific research workers.

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-02 00:00:00 至 To 2024-07-31 00:00:00

干预措施：

Interventions：

组别：

临床评价受试者

样本量：

 150

Group：

Clinical evaluation subjects

Sample size：

干预措施：

推拿、中药敷贴、饮食管理

干预措施代码：

Intervention：

Tuina, traditional Chinese medicine patches, dietary management

Intervention code：

组别：

纳入的基层医院的医生

样本量：

 10

Group：

Doctors of included primary hospitals

Sample size：

干预措施：

迁慢性腹泻理论知识培训；推拿、敷贴及饮食管理治疗迁慢性腹泻的技术培训

干预措施代码：

Intervention：

Training on theoretical knowledge of chronic diarrhea; Technical training of massage, application and diet management in the treatment of chronic diarrhea.

Intervention code：

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)：

 北京市朝阳区望京社区卫生服务中心 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Wangjing Community Health Service Center in Chaoyang District, Beijing

Level of the institution：

community health service center

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属复兴医院月坛社区卫生服务中心 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Yuetan Community Health Service Center of Fuxing Hospital Affiliated to Capital Medical University

Level of the institution：

community health service center

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京市朝阳区东风社区卫生服务中心 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Dongfeng Community Health Service Center in Chaoyang District, Beijing

Level of the institution：

community health service center

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京市石景山区中医院 

单位级别：

 二级 

Institution
hospital：

Beijing Shijingshan District Traditional Chinese Medicine Hospital

Level of the institution：

Secondary B

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京市西城区展览路医院 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Exhibition Road Hospital in Xicheng District, Beijing

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

大便次数及性状

指标类型：

主要指标

Outcome：

Fecal frequency and characteristics

Type：

Primary indicator

测量时间点：

入组第0、3、7天

测量方法：

Measure time point of outcome：

Days 0, 3 and 7 after enrollment

Measure method：

指标中文名：

中医症候积分量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Symptom Score Scale

Type：

Secondary indicator

测量时间点：

入组第0、3、7天

测量方法：

Measure time point of outcome：

Days 0, 3 and 7 after enrollment

Measure method：

指标中文名：

医师考核成绩

指标类型：

主要指标

Outcome：

Physician assessment results

Type：

Primary indicator

测量时间点：

测量方法：

理论考核+技能考核评分

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粪便

组织：

Sample Name：

feces

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 0.2 岁 years
最大 Max age 3 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是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）：

日期：2024年12月31日；方式：上传到临床试验公共管理平台ResMan (www.medresman.org.cn)

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

Date: 31 December 2024; Methods: Upload to the Clinical Trial Public Management Platform ResMan (www.medrescman. org. cn)

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：

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-04-09 10:04:14
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