ChiCTR2300077230 版本V1.1 版本创建时间2024/05/15 19:47:09 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：

 ChiCTR2300077230 

最近更新日期：

Date of Last Refreshed on：

 2023-11-02 08:50:39 

注册时间：

Date of Registration：

 2023-11-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

多维度评价腧穴敏化特征与机制研究

Public title：

Multi-dimensional evaluation of sensitization characteristics and mechanisms of acupoints research

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多维度评价腧穴敏化特征与机制研究

Scientific title：

Multi-dimensional evaluation of sensitization characteristics and mechanisms of acupoints research

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：

王雪松 

研究负责人：

佘延芬 

Applicant：

Wang Xuesong 

Study leader：

She Yanfen 

申请注册联系人电话：

Applicant telephone：

 +86 183 3215 6793

研究负责人电话：

Study leader's
telephone：

+86 158 3395 5508

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：

 wangxuesong@hebcm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 sheyanfen@163.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：

河北省石家庄市桥西区新石南路326号

研究负责人通讯地址：

河北省石家庄市鹿泉区杏苑路3号

Applicant address：

No. 326, Xinshinan Road, Qiaoxi District, Shijiazhuang City, Hebei Province, China

Study leader's address：

No.3 Xingyuan Road, Luquan District, Shijiazhuang City, Hebei 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：

河北中医药大学

Applicant's institution：

Hebei University of Chinese Medicine

研究负责人所在单位：

河北中医药大学

Affiliation of the Leader：

Hebei University of 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：

 YXLL202212031,YXLL202307003

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：

河北中医学院伦理委员会

Name of the ethic committee：

Ethics Committee of Hebei University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-11-30 00:00:00

伦理委员会联系人：

高维娟

Contact Name of the ethic committee：

Gao Weijuan

伦理委员会联系地址：

河北省石家庄市鹿泉区杏苑路3号

Contact Address of the ethic committee：

No.3 Xingyuan Road, Luquan District, Shijiazhuang City, Hebei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 188 0311 6767

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：

河北中医药大学

Primary sponsor：

Hebei University of Chinese Medicine

研究实施负责（组长）单位地址：

河北省石家庄市桥西区新石南路326号

Primary sponsor's address：

No. 326, Xinshinan Road, Qiaoxi District, Shijiazhuang City, Hebei 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)：

河北

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

河北中医药大学

具体地址：

河北省石家庄市鹿泉区杏苑路3号

Institution
hospital：

Hebei University of Chinese Medicine

Address：

No.3 Xingyuan Road, Luquan District, Shijiazhuang City, Hebei Province, China

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Bingjing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁5号

Institution
hospital：

Guang'anmen Hospita CHINA ACADEMY OF CHINESE MEDICAL SCIENCES

Address：

No.5 Beixiangge, Xicheng District, Beijing

国家：

中国

省(直辖市)：

江西

市(区县)：

Country：

China

Province：

Jiangxi

City：

单位(医院)：

江西中医药大学附属医院

具体地址：

江西省南昌市八一大道445号

Institution
hospital：

Affiliated Hospital of Jiangxi University of Chinese Medicine

Address：

No. 445, Bayi Avenue, Nanchang, Jiangxi Province, China

国家：

中国

省(直辖市)：

四川

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都中医药大学附属医院

具体地址：

四川省成都市十二桥路37号

Institution
hospital：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Address：

No.37, Shijiqiao Road, Chengdu, Sichuan, China

经费或物资来源：

国家重点研发计划资助项目（No. 2022YFC3500601）

Source(s) of funding：

National Key Research and Development Program of China (No. 2022YFC3500601)

研究疾病：

慢性萎缩性胃炎、溃疡性结肠炎、腹泻型肠易激综合征、功能性消化不良、健康人  

Target disease：

Chronic atrophic gastritis, ulcerative colitis, diarrhea-type irritable bowel syndrome, functional dyspepsia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

由于胃肠疾病的发病机制复杂，多数治疗药物存在临时起效、停药复发等问题，严重影响患者生活质量，加重社会医疗负担。针灸治疗胃肠疾病临床疗效显著，可缓解患者腹痛、改善排便频率和性状、调节情绪。敏化腧穴具有“小刺激大反应”的特点，是揭示针灸疗效特异性的关键切入点。本课题以正常人、功能性消化不良、萎缩性胃炎、肠易激综合征和溃疡性结肠炎患者为研究对象，通过多中心、大样本的横断面研究，结合审、视、切、扪、循、按6 种传统揣穴方法，采用多种客观可视化技术，观察温度、血流、痛阈以及结节/条索的变化，归纳胃肠疾病腧穴敏化规律。  

Objectives of Study：

Due to the complex pathogenesis of gastrointestinal diseases, most of the therapeutic drugs have the problems of temporary onset and recurrence after stopping, which seriously affects the quality of life of patients and aggravates the burden of social healthcare. Acupuncture and moxibustion treatment for gastrointestinal diseases is clinically effective in relieving abdominal pain, improving the frequency and character of bowel movements, and regulating emotions. Sensitized acupoints are characterized by "small stimulation and large response", which is a key entry point to reveal the specificity of acupuncture efficacy. In this study, we took normal people, functional dyspepsia, atrophic gastritis, irritable bowel syndrome and ulcerative colitis patients as the research subjects, and summarized the sensitization pattern of acupoints for gastrointestinal diseases through a multicenter and large-sample cross-sectional study, combining six traditional acupoint methods of scrutiny, visualization, incision, searching, following and pressing, and observing the changes of temperature, blood flow, pain threshold and nodule/stripe by adopting a variety of objective visualization techniques.

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.功能性消化不良 （1）纳入标准 ①符合罗马IV功能性消化不良的诊断标准：中上腹痛；早饱不适感；餐后饱胀不适；中上腹部烧灼感；②年龄20-70岁，性别不限；③常规检查未发现可解释上述症状的器质性或代谢性疾病的疾病；④症状出现至少6个月，近3个月持续存在；⑤有警报症状的患者需提供近2年内的胃镜检查报告； 2.腹泻型肠易激综合征 （1）纳入标准：①符合上述罗马IV腹泻型肠易激综合征亚型诊断标准：与排便相关；伴有排便频率改变；伴有粪便性状（外观）改变（Bristol粪便性状6型或7型＞1/4，且Bristol粪便性状1型或2型＜1/4）；②年龄20-70岁，性别不限；③发作时伴有排便频率改变；④症状出现至少6个月，近3个月持续存在；⑤有警报症状的患者需要提供近2年内的结肠镜检查报告； 3.慢性萎缩性胃炎 （1）纳入标准：①符合上述萎缩性胃炎专家的诊断标准：满足胃镜诊断：a.内镜下见胃黏膜红白相间，白相为主，皱襞变平甚至消失；b.部分黏膜血管显露，可伴有黏膜颗粒或结节状等表现；c.或其他关于萎缩相关的描述（满足其中一条）；或者满足病理诊断：a.胃黏膜萎缩或固有腺体萎缩；b.胃黏膜肠上皮化生；c.胃黏膜异型增生；d.或其他关于萎缩相关的描述（满足其中一条）；②年龄20-70岁，性别不限；③提供近2年内的胃镜或病理检查报告； 4.溃疡性结肠炎 （1）纳入标准：①符合成人溃疡性结肠炎诊断标准：持续或反复发作的腹泻；黏液脓血便伴腹痛；里急后重；病程在6周以上；②年龄20-70岁，性别不限；③结直肠镜、钡灌肠、CT或MRI显示结肠显像见典型溃疡性结肠炎改变；④需提供近2年内的结直肠镜检查报告； 5.正常人 （1）纳入标准：①经体检合格的正常人，无心、肝、肺、肾等重要脏器疾患；②年龄20-70岁（与疾病组人群进行年龄和性别匹配招募）；③经检查无胃肠系统疾病；

Inclusion criteria

1. Functional dyspepsiaInclusion criteria ① meet the diagnostic criteria of Rome IV functional dyspepsia: middle and upper abdominal pain; Early satiety discomfort; Fullness and discomfort after meals; Burning sensation in the middle and upper abdomen; Age 20-70 years old, gender is not limited; (3) No organic or metabolic disease that can explain the above symptoms was found in routine examination; ④ Symptoms appear for at least 6 months and persist for nearly 3 months; ⑤ Patients with warning symptoms should provide gastroscopy reports in the past 2 years; 2. Diarrheal irritable bowel syndrome Inclusion criteria: ① Meeting the diagnostic criteria of Rome IV diarrheal irritable bowel syndrome subtype: related to defecation; Accompanied by changes in bowel frequency; Accompanied by changes in fecal traits (appearance) (Bristol fecal traits type 6 or 7 > 1/4, and Bristol fecal traits type 1 or 2 < 1/4); Age 20-70 years old, gender is not limited; (3) accompanied by a change in the frequency of defecation; ④ Symptoms appear for at least 6 months and persist for nearly 3 months; (5) Patients with alarm symptoms should provide colonoscopy reports within the last 2 years; 3. Chronic atrophic gastritis (1) Inclusion criteria: ① Meet the above diagnostic criteria of atrophic gastritis experts: meet the gastroscopy diagnosis: a. Under the endoscope, the gastric mucosa showed red and white phases, mainly white phases, and the folds were flattened or even disappeared. b. Some mucosal blood vessels are exposed, which may be accompanied by mucosal granules or nodules; c. or other descriptions of atrophy (meet one of them); Or meet the pathological diagnosis: a. gastric mucosa atrophy or intrinsic gland atrophy; b. Gastric mucosa intestinal metaplasia; c. Gastric mucosal dysplasia; d. or other descriptions of atrophy (meet one of them); Age 20-70 years old, gender is not limited; ③ Provide gastroscopy or pathological examination reports in the past 2 years; 4. Ulcerative colitis (1) Inclusion criteria: ① meet the diagnostic criteria for adult ulcerative colitis: persistent or recurrent diarrhea; Mucous, pus and blood stool with abdominal pain; Posterior hypersomia; The course of the disease is more than 6 weeks; Age 20-70 years old, gender is not limited; (3) Colonoscopy, barium enema, CT or MRI showed changes in typical ulcerative colitis. (4) The colonoscopy report within the last 2 years should be provided; 5. Normal People (1) Inclusion criteria: ① Normal people who have passed the physical examination and suffer from diseases of important organs such as heart, liver, lung and kidney; (2) Age 20-70 years old (age and gender matching recruitment with disease group); ③ No gastrointestinal diseases were detected;

排除标准：

1.功能性消化不良 （1）①意识不清、不能表达主观不适症状者及精神病患者；②患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；③探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；④患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；⑤近一周发热、前一天剧烈运动导致肌肉酸痛者；⑥备孕、妊娠期或哺乳期妇女； 2.腹泻型肠易激综合征 （1）排除标准：①便秘型/混合型IBS，炎性肠病、克罗恩病等器质性肠病者； ②意识不清、不能表达主观不适症状者及精神病患者；③患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；④探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；⑤患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；⑥近一周发热、剧烈运动导致肌肉酸痛者；⑦备孕、妊娠期或哺乳期妇女； 3.慢性萎缩性胃炎 （1）排除标准：①伴有胃溃疡、十二指肠溃疡、特殊类型胃炎或消化道出血；②胃镜或病理活检已示癌变者，影像学检查提示癌转移者；③意识不清、不能表达主观不适症状者及精神病患者；④患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；⑤探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；⑥患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；⑦近一周发热、前一天剧烈运动导致肌肉酸痛者；⑧备孕、妊娠期或哺乳期妇女； 4.溃疡性结肠炎 （1）排除标准：①病变类型为急性爆发型；②感染性肠病、克罗恩病、缺血性肠病、放射性肠炎等患者；③合并严重并发症者，如中毒性肠扩张、肠梗阻、肠穿孔、大出血等，合并结肠癌、直肠癌者，及结肠切除术史；④意识不清、不能表达主观不适症状者及精神病患者；⑤探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；⑥患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；⑦近一周发热、前一天剧烈运动导致肌肉酸痛者；⑧备孕、妊娠期或哺乳期妇女； 5.正常人 （1）排除标准：①患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；②探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；③近一周发热、前一天剧烈运动导致肌肉酸痛者；

Exclusion criteria：

1. Functional dyspepsia(1) Patients with unclear consciousness, unable to express subjective discomfort symptoms and mental patients; Have chronic diseases that may cause indigestion, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; ③ Detection of acupoints with local scar, skin disease and peripheral nervous system diseases; (4) People with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; ⑤ Those who have fever for nearly a week and muscle soreness caused by strenuous exercise the day before; ⑥ Pregnant, pregnant or lactating women; 2. Diarrheal irritable bowel syndrome (1) Exclusion criteria: ① Patients with constipated/mixed IBS, inflammatory bowel disease, Crohn's disease and other organic bowel diseases; ② Patients with unconsciousness, unable to express subjective discomfort symptoms and mental patients; Have chronic diseases that may cause indigestion symptoms, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; ④ To detect local scar, skin disease and peripheral nervous system disease at acupoints; (5) People with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; ⑥ People with fever and muscle soreness caused by intense exercise in the past week; ⑦ Pregnant, pregnant or lactating women; 3. Chronic atrophic gastritis (1) Exclusion criteria: ① accompanied by gastric ulcer, duodenal ulcer, special type of gastritis or gastrointestinal bleeding; ② Gastroscopy or pathological biopsy has shown cancer, imaging examination suggests cancer metastasis; ③ Patients with unconsciousness, unable to express subjective discomfort symptoms and mental patients; Have chronic diseases that may cause indigestion, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; ⑤ Detection of acupoints with local scars, skin diseases and peripheral nervous system diseases; ⑥ suffer from diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; ⑦ Those with fever for nearly a week and muscle soreness caused by intense exercise the day before; Women who are pregnant, pregnant or breastfeeding; 4. Ulcerative colitis (1) Exclusion criteria: ① The lesion type was acute outbreak type; ② Patients with infectious enteropathy, Crohn's disease, ischemic enteropathy, radiation enteritis, etc. ③ Patients with severe complications, such as toxic intestinal dilation, intestinal obstruction, intestinal perforation, massive hemorrhage, colon cancer, rectal cancer, and history of colectomy; (4) Patients with unclear consciousness, unable to express subjective discomfort symptoms and mental patients; ⑤ Detection of acupoints with local scars, skin diseases and peripheral nervous system diseases; ⑥ suffer from diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; ⑦ Those with fever for nearly a week and muscle soreness caused by intense exercise the day before; Women who are pregnant, pregnant or breastfeeding; 5. Normal People (1) Exclusion criteria: ① patients with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; ② Detection of acupoints with local scar, skin disease and peripheral nervous system diseases; ③ Those who have fever for nearly a week and muscle soreness caused by strenuous exercise the day before;

研究实施时间：

Study execute time：

从 From 2023-11-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-02 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

慢性萎缩性胃炎

样本量：

 300

Group：

Chronic atrophic gastritis

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

溃疡性结肠炎

样本量：

 300

Group：

Ulcerative colitis

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

腹泻型肠易激综合征

样本量：

 300

Group：

Diarrheal irritable bowel syndrome

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

功能性消化不良

样本量：

 300

Group：

Functional dyspepsia

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

正常组

样本量：

 300

Group：

Normal control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 河北中医药大学 

单位级别：

 大学 

Institution
hospital：

Hebei University of Chinese Medicine

Level of the institution：

University

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国中医科学院广安门医院 

单位级别：

 三甲 

Institution
hospital：

Guang'anmen Hospita CHINA ACADEMY OF CHINESE MEDICAL SCIENCES

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

  

Country：

China

Province：

Jiangxi

City：

单位(医院)：

 江西中医药大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Jiangxi University of Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 成都中医药大学附属医院 

单位级别：

 大学 

Institution
hospital：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

穴位体表温度

指标类型：

主要指标

Outcome：

Body Surface Temperature at Acupuncture Points

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穴区体表平均血流灌注量

指标类型：

主要指标

Outcome：

Mean body surface perfusion in the acupoint area

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穴区压痛阈值

指标类型：

主要指标

Outcome：

Pressure pain threshold at acupoints

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穴区深部血流频谱

指标类型：

次要指标

Outcome：

Spectrum of deep blood flow in the acupoint area

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穴区ROI血流信号比

指标类型：

次要指标

Outcome：

ROI blood flow signal ratio in acupoint area

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 20 岁 years
最大 Max age 70 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）：

不适用

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

N/A

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）：

待试验结束后，原始数据请联系研究负责人进行获取。

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

Please contact the study leader to obtain the raw data when the experiment is completed.

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：

使用电子采集和管理系统(Electronic Data Capture, EDC)收集和管理数据

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

Collection and management of data using Electronic Data Capture (EDC) systems

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-11-02 08:50:35