Clinical efficacy evaluation of Jieyu Dawei Formula for postprandial discomfort syndrome (liver stomach disharmony syndrome) in functional dyspepsia with mild anxiety and depression

注册号:

Registration number:

ITMCTR2025000071

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

解郁达胃方对功能性消化不良餐后不适综合征伴轻度焦虑抑郁(肝胃不和证)的临床疗效评价

Public title:

Clinical efficacy evaluation of Jieyu Dawei Formula for postprandial discomfort syndrome (liver stomach disharmony syndrome) in functional dyspepsia with mild anxiety and depression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

解郁达胃方对功能性消化不良餐后不适综合征伴轻度焦虑抑郁(肝胃不和证)的临床疗效评价

Scientific title:

Clinical efficacy evaluation of Jieyu Dawei Formula for postprandial discomfort syndrome (liver stomach disharmony syndrome) in functional dyspepsia with mild anxiety and depression

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:

石磊

研究负责人:

石磊

Applicant:

Shi Lei

Study leader:

Shi Lei

申请注册联系人电话:

Applicant telephone:

15110026632

研究负责人电话:

Study leader's telephone:

15110026632

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:

klmysl1205@126.com

研究负责人电子邮件:

Study leader's E-mail:

klmysl1205@126.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:

北京市丰台区方庄芳星园一区六号北京中医药大学东方医院

研究负责人通讯地址:

北京市丰台区方庄芳星园一区六号北京中医药大学东方医院

Applicant address:

Dongfang Hospital Beijing University of Chinese Medicine No. 6 Fangzhuang Fangxingyuan District 1 Fengtai District Beijing

Study leader's address:

Dongfang Hospital Beijing University of Chinese Medicine No. 6 Fangzhuang Fangxingyuan District 1 Fengtai 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:

北京中医药大学东方医院

Applicant's institution:

Dongfang Hospital Beijing University of Chinese Medicine

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:

JDF-IRB-2024031402

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:

北京中医药大学东方医院临床研究伦理委员会

Name of the ethic committee:

IRB of Dongfang Hospital Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/9 0:00:00

伦理委员会联系人:

夏芸

Contact Name of the ethic committee:

Xia Yun

伦理委员会联系地址:

北京市丰台区方庄芳星园一区六号北京中医药大学东方医院

Contact Address of the ethic committee:

Dongfang Hospital Beijing University of Chinese Medicine No. 6 Fangzhuang Fangxingyuan District 1 Fengtai District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-67654807

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dfyyec@126.com

研究实施负责(组长)单位:

北京中医药大学东方医院

Primary sponsor:

Dongfang Hospital Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市丰台区方庄芳星园一区六号北京中医药大学东方医院

Primary sponsor's address:

Dongfang Hospital Beijing University of Chinese Medicine No. 6 Fangzhuang Fangxingyuan District 1 Fengtai 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):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市中医管理局

具体地址:

北京市通州区达济街6号院

Institution
hospital:

Beijing Administration of Traditional Chinese Medicine

Address:

No. 6 Daji Street Tongzhou District Beijing

经费或物资来源:

北京市中医管理局

Source(s) of funding:

Beijing Administration of Traditional Chinese Medicine

研究疾病:

功能性消化不良

研究疾病代码:

Target disease:

Functional dyspepsia

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

明确解郁达胃方对功能性消化不良餐后不适综合征伴轻度焦虑抑郁(肝胃不和证)的临床疗效及安全性。

Objectives of Study:

Clarify the clinical efficacy and safety of Jieyu Dawei Formula for functional dyspepsia with postprandial discomfort syndrome accompanied by mild anxiety and depression (liver stomach disharmony syndrome).

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)符合功能性消化不良餐后不适综合征的西医诊断标准; (2)符合轻度焦虑和(或)轻度抑郁诊断,即50≤SAS≤59分和(或)53≤SAS≤62分; (3)符合肝胃不和证的中医证候诊断标准; (4)年龄在 18~80 岁之间; (5)自愿参加并签署知情同意书。

Inclusion criteria

(1) Meets the Western diagnostic criteria for functional dyspepsia postprandial discomfort syndrome; (2) Meets the diagnosis of mild anxiety and/or mild depression i.e. 50 ≤ SAS ≤ 59 points and/or 53 ≤ SAS ≤ 62 points; (3) Meets the traditional Chinese medicine diagnostic criteria for liver stomach disharmony syndrome; (4) Age between 18 and 80 years old; (5) Voluntarily participate and sign an informed consent form.

排除标准:

(1)消化系统器质性疾病引起的消化不良,如消化性溃疡、反流性食管炎、糜烂性胃炎、萎缩性胃炎、消化道肿瘤、消化道出血、肝胆胰腺疾病、胃轻瘫、肠梗阻、炎症性肠病等; (2)Hp 检查阳性或正在行四联药物根除HP者; (3)进行性吞咽困难,持续性呕吐及无意识的体重下降者; (4)有胃肠外科手术史者(阑尾切除术除外); (5)免疫功能缺陷(如白血病、肿瘤患者等),或近 3 个月内使用免疫抑制剂或糖皮质激素者; (6)合并严重心功能不全,肝(ALT/AST超过正常值上限1.5倍)、肾功能(血肌酐超过正常值上限1.5倍)、造血系统异常者; (7)具有严重的原发性心、脑、肝、肺、肾、血液或影响其生存的严重疾病者; (8)法律规定的残疾患者(盲、聋、哑、智力障碍、精神障碍、肢体残疾); (9)妊娠(育龄期妇女妊娠试验阳性者)或哺乳期妇女,近期有生育计划的患者; (10)对本制剂药物组成成分过敏者; (11)近3个月参加过或正在参加其他药物临床试验者,或服用的药物可能对试验药物的有效性评估产生影响; (12)怀疑或确有酒精、药物滥用病史,或服用的药物可能对试验药物的有效性评估产生影响(如抑酸/制酸药、非甾体类抗炎药、抗胆碱能药物、糖皮质激素、抗焦虑抑郁药等); (13)研究者认为不适宜参加临床试验者。

Exclusion criteria:

(1) Digestive disorders caused by organic diseases of the digestive system such as peptic ulcers reflux esophagitis erosive gastritis atrophic gastritis gastrointestinal tumors gastrointestinal bleeding hepatobiliary and pancreatic diseases gastroparesis intestinal obstruction inflammatory bowel disease etc; (2) Individuals who test positive for Hp or are undergoing quadruple therapy to eradicate HP; (3) Individuals with progressive dysphagia persistent vomiting and unconscious weight loss; (4) Individuals with a history of gastrointestinal surgery (excluding appendectomy); (5) Individuals with immune dysfunction (such as leukemia cancer patients etc.) or those who have used immunosuppressants or glucocorticoids in the past 3 months; (6) Patients with severe heart failure liver (ALT/AST exceeding 1.5 times the upper limit of normal) kidney function (blood creatinine exceeding 1.5 times the upper limit of normal) and hematopoietic system abnormalities; (7) Individuals with severe primary heart brain liver lung kidney blood or serious diseases that affect their survival; (8) Disabled patients as defined by law (blind deaf mute intellectually disabled mentally disabled physically disabled); (9) Pregnant (women of childbearing age who test positive for pregnancy) or lactating women and patients who have recently planned to have children; (10) Individuals who are allergic to the components of this medication; (11) Individuals who have participated in or are currently participating in clinical trials of other drugs in the past 3 months or whose medication may have an impact on the efficacy evaluation of the investigational drug; (12) Suspecting or having a history of alcohol or drug abuse or taking drugs that may affect the effectiveness evaluation of the investigational drug (such as acid suppressants/antacids nonsteroidal anti-inflammatory drugs anticholinergic drugs glucocorticoids antidepressants etc.); (13) Researchers believe that participants are not suitable for clinical trials.

研究实施时间:

Study execute time:

From 2024-11-01

To      2025-08-31

征募观察对象时间:

Recruiting time:

From 2025-03-01

To      2025-08-31

干预措施:

Interventions:

组别:

治疗组

样本量:

36

Group:

Treatment group

Sample size:

干预措施:

解郁达胃方

干预措施代码:

Intervention:

Jieyu Dawei Formula

Intervention code:

组别:

对照组

样本量:

36

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

样本总量 Total sample size : 72

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):

北京中医药大学东方医院

单位级别:

三级

Institution/hospital:

Dongfang Hospital Beijing University of Chinese Medicine

Level of the institution:

Grade III

测量指标:

Outcomes:

指标中文名:

肾功能(BUN)

指标类型:

副作用指标

Outcome:

Renal function (BUN)

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候评分

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Syndrome 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:

肾功能(Cr)

指标类型:

副作用指标

Outcome:

Renal function (Cr)

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

Urinalysis

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性消化不良生存质量评分

指标类型:

次要指标

Outcome:

Functional dyspepsia quality of life 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:

心电图

指标类型:

副作用指标

Outcome:

Electrocardiogram

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般生命体征

指标类型:

副作用指标

Outcome:

General vital signs

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

Blood routine

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单项症状疗效

指标类型:

次要指标

Outcome:

Single symptom efficacy

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SAS自评量表评分

指标类型:

次要指标

Outcome:

SAS Self Rating 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:

不良反应

指标类型:

副作用指标

Outcome:

Adverse reactions

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能(ALT)

指标类型:

副作用指标

Outcome:

Liver function (ALT)

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规+潜血

指标类型:

副作用指标

Outcome:

Routine stool test+occult blood test

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要症状严重程度有效率

指标类型:

主要指标

Outcome:

Effective rate of severity of main symptoms

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

莫沙必利片使用量

指标类型:

次要指标

Outcome:

Dosage of Mosapride tablets

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SDS自评量表评分

指标类型:

次要指标

Outcome:

SDS Self Rating 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:

肝功能(AST)

指标类型:

副作用指标

Outcome:

Liver function (AST)

Type:

Adverse events

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:

胃黏膜

组织:

Sample Name:

Gastric mucosa

Tissue:

人体标本去向

使用后保存

说明

保存10年,用于后续研究

Fate of sample 

Preservation after use

Note:

Save for 10 years for subsequent scientific research

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存

说明

保存10年,用于后续研究

Fate of sample 

Preservation after use

Note:

Save for 10 years for subsequent scientific research

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后保存

说明

保存10年,用于后续研究

Fate of sample 

Preservation after use

Note:

Save for 10 years for subsequent scientific research

标本中文名:

粪便

组织:

Sample Name:

Stool

Tissue:

人体标本去向

使用后保存

说明

保存10年,用于后续研究

Fate of sample 

Preservation after use

Note:

Save for 10 years for subsequent scientific research

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
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):

由统计专业人员利用SAS软件产生的随机数字按照统一序号产生序列。

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

The random numbers generated by statistical professionals using SAS software are sequenced according to a uniform number.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

2026年1月1日后,联系课题负责人共享数据

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

Contact the project leader to share data after January 1, 2026

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:

数据采集采用CRF表 数据管理由专人在系统录入核对、管理数据

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

Data collection adopts CRF table Data management is carried out by dedicated personnel who input verify and manage data in the system

数据管理委员会:

Data Managemen Committee:

No

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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