ChiCTR2300074340 版本V1.0 版本创建时间2023/08/03 18:39:44 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：

 ChiCTR2300074340 

最近更新日期：

Date of Last Refreshed on：

 2023-08-03 18:39:26 

注册时间：

Date of Registration：

 2023-08-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

辛开苦降法干预非糜烂性胃食管反流病合并焦虑抑郁患者内脏敏感性的 RCT 研究

Public title：

RCT study on the intervention of visceral sensitivity in patients with non erosive gastroesophageal reflux disease combined with anxiety and depression using Xin Kai Ku Jiang method

注册题目简写：

English Acronym：

研究课题的正式科学名称：

辛开苦降法干预非糜烂性胃食管反流病合并焦虑抑郁患 者内脏敏感性的 RCT 研究

Scientific title：

RCT study on the intervention of visceral sensitivity in patients with non erosive gastroesophageal reflux disease combined with anxiety and depression using Xin Kai Ku Jiang method

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：

魏仕兵 

研究负责人：

来要良 

Applicant：

wei shi bing 

Study leader：

lai yao liang 

申请注册联系人电话：

Applicant telephone：

 +86 138 1126 9618

研究负责人电话：

Study leader's
telephone：

+86 136 9144 6877

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：

 wsbsp60@126.com

研究负责人电子邮件：

Study leader's E-mail：

 yaoliang010@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：

北京市西城区万明路13号

研究负责人通讯地址：

北京市西城区万明路13号

Applicant address：

13 Wanming Road, Xicheng District, Beijing

Study leader's address：

13 Wanming Road, Xicheng 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：

北京市宣武中医医院

Applicant's institution：

Beijing Xuanwu Traditional Chinese Medical Hospital

研究负责人所在单位：

北京市宣武中医医院

Affiliation of the Leader：

Beijing Xuanwu Traditional Chinese Medical Hospital

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：

 2023-002-02

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：

北京市宣武中医医院伦理委员会

Name of the ethic committee：

Xuan Wu TCM Hospital Beijing IRB

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-06-05 00:00:00

伦理委员会联系人：

关慧泉

Contact Name of the ethic committee：

Guan Hui Quan

伦理委员会联系地址：

北京市西城区万明路13号

Contact Address of the ethic committee：

13 Wanming Road, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8377 6562

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：

北京市宣武中医医院

Primary sponsor：

Beijing Xuanwu Traditional Chinese Medical Hospital

研究实施负责（组长）单位地址：

北京市西城区万明路13号

Primary sponsor's address：

13 Wanming Road, Xicheng 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

市(区县)：

北京

Country：

china

Province：

beijing

City：

beijing

单位(医院)：

北京市科学技术委员会

具体地址：

北京市通州区运河东大街57号院1号楼

Institution
hospital：

Beijing Municipal Science & Technology Commission

Address：

Building 1, Courtyard 57 Yunhe East Street, Tongzhou District, Beijing

国家：

中国

省(直辖市)：

北京市

市(区县)：

北京

Country：

china

Province：

beijing

City：

beijing

单位(医院)：

中关村科技园区管理委员会

具体地址：

北京市通州区运河东大街57号院1号楼

Institution
hospital：

Administrative Commission of Zhongguancun Science Park

Address：

Building 1, Courtyard 57 Yunhe East Street, Tongzhou District, Beijing

经费或物资来源：

北京市科学技术委员会、中关村科技园区管理委员会

Source(s) of funding：

Beijing Municipal Science & Technology Commission , Administrative Commissionof Zhongguancun Science Park

研究疾病：

非糜烂性胃食管反流病  

Target disease：

Non -erosion gastroesophageal reflux disease

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

非糜烂性胃食管反流病（ Non - erosive reflux disease , NERD )是消化系统常见的疾病之一。近年来许多研究均显示了精神心理因素与胃食管反流病也存在密切的联系。精神心理因素会影响个人对反流症状的感知，导致感知的阈值降低，改变了食管对刺激的感知，加重反流症状；而长期反流症状引起的不适感又会加重患者的心理负担。因此NERD合并焦虑抑郁在临床中极为常见。由于精神心理障碍与NERD的发生、发展可能互为因果、相互影响，单独处理共病中的单一疾病均无法彻底改善患者症状，因此对这种共病的研究成为当前消化心身医学研究的热点和难点。PPI联合抗焦虑抑郁药物治疗有一定的疗效，但是存在抗焦虑抑郁药物使用不规范，从而导致药物滥用，出现药物毒副作用、药物耐受和依赖性等问题。我院名老中医认为本病的基本病机是寒热错杂、虚实夹杂、肝胃郁热。故辛开苦降，清肝和胃为基本治则。因此本研究采用辛开苦降法治疗NERD合并焦虑抑郁患者，目的在于评价辛开苦降法治疗NERD合并焦虑抑郁的临床疗效、明确辛开苦降法对NERD合并焦虑抑郁患者内脏敏感性的调节作用及相关机制。  

Objectives of Study：

Non erosive reflux disease (NERD) is one of the common diseases in the digestive system. In recent years, many studies have shown a close relationship between psychological factors and gastroesophageal reflux disease. Psychological factors can affect an individual's perception of reflux symptoms, leading to a decrease in the threshold of perception, altering the esophagus's perception of stimuli, and exacerbating reflux symptoms; The discomfort caused by long-term reflux symptoms can exacerbate the psychological burden on patients. Therefore, NERD combined with anxiety and depression is extremely common in clinical practice. Due to the mutual causality and influence between the occurrence and development of mental and psychological disorders and NERD, treating a single comorbidity alone cannot completely improve patient symptoms. Therefore, research on this comorbidity has become a hot and difficult topic in current digestive, psychosomatic medicine research. The combination of PPI and anti anxiety and depression drugs has a certain therapeutic effect, but there are problems with non-standard use of anti anxiety and depression drugs, leading to drug abuse, drug toxicity, drug tolerance, and dependence. Our hospital's renowned traditional Chinese medicine believes that the basic pathogenesis of this disease is a mixture of cold and heat, deficiency and excess, and liver and stomach stagnation. Therefore, the basic treatment principle is to clear the liver and stomach, with the opening of bitterness and lowering of bitterness. Therefore, this study adopts the Xin Kai Ku Jiang method to treat NERD patients with anxiety and depression, with the aim of evaluating the clinical efficacy of Xin Kai Ku Jiang method in treating NERD patients with anxiety and depression, and clarifying the regulatory effect and related mechanisms of Xin Kai Ku Jiang method on visceral sensitivity in NERD patients with anxiety and depression.

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、临床症状符合NERD合并轻中度焦虑抑郁中西医诊断标准；2、年龄在18-65岁之间，性别不限；3、无重度焦虑抑郁状态，无自杀倾向；4、受试者知情，自愿签署知情同意书。

Inclusion criteria

1. The clinical symptoms meet the diagnostic criteria of traditional Chinese medicine and Western medicine for NERD combined with mild to moderate anxiety and depression; 2. Between the ages of 18 and 65, regardless of gender; 3. No severe anxiety or depression, no suicidal tendencies; 4. The subject is informed and voluntarily signs an informed consent form.

排除标准：

糜烂性胃炎、胃溃疡、十二指肠溃疡等胃部器质性疾病者；妊娠期、哺乳期妇女；有结缔组织疾病、糖尿病等内分泌代谢疾病者、更年期综合症者；具有严重的原发性心、肝、肺、肾、血液或影响其生存的严重疾病者；法律规定的残疾患者（盲，聋，哑，智力障碍，精神障碍，肢体残疾）；怀疑或确有酒精、药物滥用病史；根据研究者的判断、具有降低入组可能性或使入组复杂化的其他病变，如工作环境经常变动等易造成失访的情况；过敏体质，如对两种或以上药物或食物过敏史者；或已知对本药成分过敏者；正在参加其他药物临床试验的患者；处于重度焦虑抑郁状态，有自杀倾向的患者。

Exclusion criteria：

Patients with gastric organic diseases such as erosive gastritis, gastric ulcer, and duodenal ulcer; Pregnant and lactating women; People with connective tissue diseases, diabetes and other endocrine and metabolic diseases, and menopausal syndrome; Individuals with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival; Disabled patients (blind, deaf, mute, intellectually disabled, mentally disabled, physically disabled) as stipulated by law; Suspected or confirmed history of alcohol or drug abuse; According to the judgment of the researcher, other pathological changes that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, may lead to loss of follow-up; Allergic constitution, such as a history of allergies to two or more drugs or foods; Or known to be allergic to the ingredients of this medicine; Patients participating in clinical trials of other drugs; Patients who are in a state of severe anxiety and depression and have a tendency to commit suicide.

研究实施时间：

Study execute time：

从 From 2022-11-01 00:00:00至 To 2025-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-09-01 00:00:00 至 To 2025-07-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 45

Group：

the Test group

Sample size：

干预措施：

给予辛开苦降法配方颗粒（清半夏9g，黄芩10g，黄连8g，吴茱萸3g，太子参10g，紫苏梗 10g，白芍10g，厚朴 10g，浙贝母10g，郁金10g，柴胡10g，枳壳10g），口服1 剂/日，两包/剂，早晚各1 次，1 包/次，服用前以80 摄氏度热水将配方颗粒充分溶解，温度适口后服用；同时口服泮托拉唑肠溶胶囊模拟剂，1 个/次，1 次/日；口服氟哌噻吨美利曲辛片（黛力新）模拟剂，早晨及中午各1粒。疗程为4周。

干预措施代码：

Intervention：

Administer Xin Kai Ku Jiang Fa formula granules (9g of Pinellia ternata, 10g of Scutellaria baicalensis, 8g of Coptis chinensis, 3g of Fructus Evodiae, 10g of Radix Pseudostellariae, 10g of Perilla frutescens, 10g of Radix Paeoniae Alba, 10g of Magnolia officinalis, 10g of Fritillaria thunbergii, 10g of Turmeric, 10g of Bupleurum chinense, and 10g of Fructus Aurantii), orally take one dose per day, two packs per dose, one in the morning and one in the evening, one pack per dose per dose. Dissolve the formula granules thoroughly in hot water at 80 degrees Celsius before taking, and take at; At the same time, take orally pantoprazole enteric coated capsule simulant, once a time, once a day; Oral administration of flupenthizumab and melitracin tablets (Deanxit) as a simulated agent, taking 1 tablet in the morning and 1 tablet in the afternoon. The treatment period is 4 weeks.

Intervention code：

组别：

对照组

样本量：

 45

Group：

the Control group

Sample size：

干预措施：

给予泮托拉唑肠溶胶囊（40mg×7个/盒）口服，1个/次，1次/日；氟哌噻吨美利曲辛片（黛力新，0.5mg:10mg×20片/盒）口服，早晨及中午各1粒；同时服用中药配方颗粒模拟剂（以糊精赋形物为主，加入治疗组中药剂量的1/10，以保留中药特有气味），口服1 剂/日，两包/剂，早晚各1 次，1 包/次，服用前以80 摄氏度热水将配方颗粒充分溶解，温度适口后服用。疗程为4周。

干预措施代码：

Intervention：

Give Pantoprazole enteric coated capsules (40mg × 7 pieces/box) orally, 1 piece/time, 1 time/day; Flupenthizumab Melitracen Tablets (Deanxit, 0.5mg: 10mg) × 20 tablets/box) orally, 1 tablet in the morning and 1 tablet in the afternoon; Simultaneously take a traditional Chinese medicine formula particle simulation agent (mainly composed of dextrin shaper, added to 1/10 of the treatment group's traditional Chinese medicine dose to retain the unique odor of traditional Chinese medicine), orally take one dose per day, two packs per dose, once in the morning and once in the evening, one pack per dose. Before taking, dissolve the formula particles thoroughly in 80 degrees Celsius hot water, and take it at a suitable temperature. The treatment period is 4 weeks.

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 

市(区县)：

  

Country：

china

Province：

beijing

City：

单位(医院)：

 北京市宣武中医医院 

单位级别：

 三级 

Institution
hospital：

Beijing Xuanwu Traditional Chinese Medical Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

胆囊收缩素

指标类型：

次要指标

Outcome：

cholecystokinin

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃动素

指标类型：

次要指标

Outcome：

motilin

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多通道阻抗-pH检测值

指标类型：

次要指标

Outcome：

multi-channel impedance pH detection values

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃电图

指标类型：

次要指标

Outcome：

Electrogastrography

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

P物质

指标类型：

次要指标

Outcome：

substance P

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

5羟色胺

指标类型：

次要指标

Outcome：

5-hydroxytryptamine

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多巴胺

指标类型：

次要指标

Outcome：

dopamine

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

白介素-6

指标类型：

次要指标

Outcome：

interleukin-6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

白介素-10

指标类型：

次要指标

Outcome：

interleukin-10

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

降钙素基因相关肽

指标类型：

次要指标

Outcome：

Calcitonin gene related peptide

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主要症状积分

指标类型：

主要指标

Outcome：

Main symptom 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：

汉密尔顿焦虑量表

指标类型：

主要指标

Outcome：

Hamilton Anxiety 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：

汉密尔顿抑郁量表

指标类型：

主要指标

Outcome：

Hamilton Depression Scale

Type：

Primary 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：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

大便

组织：

Sample Name：

stool

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 65 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）：

项目负责人采用SPSS软件产生随机序列

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

The project leader uses SPSS software to generate random sequence

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：

根据随机数字表，按试验组和对照组进行随机编号，并将编号注明在包装袋上。将受试者药物每一周剂量包装成 1份，采用相同的外包装，并注明代码。保证中药颗粒剂、模拟剂、安慰剂在外观、形状、颜色上基本一致。研究者按照受试者入选的顺序服药（如为16号），将随机代码号（如16）填写在病历记录表上，并通知药房发放相应的随机代码号相同的试验药品。

Blinding：

According to the random number table, randomly number the test group and control group, and indicate the number on the packaging bag. Package the subject's medication in 1 portion per week, using the same outer packaging and indicating the code. Ensure that traditional Chinese medicine granules, simulants, and placebos are basically consistent in appearance, shape, and color. The researcher takes the medication in the order in which the subjects are selected (such as number 16), fills in the random code number (such as number 16) on the medical record form, and notifies the pharmacy to distribute the corresponding experimental drug with the same random code number.

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）：

不共享

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

not shared

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）经筛查纳入试验者填写临床信息采集表，（2）临床调查应在安静、舒适的环境下进行，保证过程不受干扰，（3）填写临床信息采集表一律采用黑色签字笔，（4）观察表的填写必须真实、准确、清晰、不得随意涂改，错误之处如需纠正，需横线居中划出，并签署修改者姓名及修改时间，（5）CRF 表应妥善保管，放置妥善，不得随意放置丢弃。（6）用EpiData3.0 建立数据库，由两人独立进行数据录入，如遇不一致，需溯源原始资料，并通过课题组内2 名以上专家讨论处理，数据录入后进行二次检验，再由另外两人进行修改，直至两个数据库完全一致。数据录入完成后锁定，将数据交试验统计学专业人员进行统计分析。

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

(1) After screening, participants who have been included in the trial should fill out the clinical information collection form. (2) The clinical investigation should be conducted in a quiet and comfortable environment to ensure that the process is not disturbed. (3) All clinical information collection forms should be filled out with black signature pens. (4) The filling out of the observation form must be true, accurate, clear, and cannot be arbitrarily altered. If any errors need to be corrected, they should be marked in the center with a horizontal line, and the name of the modifier and the modification time should be signed, (5) CRF forms should be properly kept and placed, and should not be placed or discarded arbitrarily. (6) Establish a database using EpiData3.0 and allow two individuals to independently input data. If there is any inconsistency, the original data needs to be traced and processed through discussions with two or more experts in the research group. After the data is entered, a secondary inspection is conducted, and the other two individuals make modifications until the two databases are completely consistent. After the data entry is completed, lock it and hand it over to experimental statistics professionals for statistical analysis.

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：

  2023-08-03 18:39:26