中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400083207
最近更新日期： Date of Last Refreshed on：	2024-04-18 11:46:59
注册时间： Date of Registration：	2024-04-18 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	健脾养肝丸治疗IBS-D肝郁脾虚型患者的疗效观察
Public title：	An observational study on the therapeutic effect of Jianpi Yanggan Pill in the treatment of IBS-D patients with liver-depression and spleen-deficiency phenotype
注册题目简写：
English Acronym：
研究课题的正式科学名称：	健脾养肝丸治疗IBS-D肝郁脾虚型患者的疗效观察
Scientific title：	An observational study on the therapeutic effect of Jianpi Yanggan Pill in the treatment of IBS-D patients with liver-depression and spleen-deficiency phenotype
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：	马可	研究负责人：	马可
Applicant：	Ke Ma	Study leader：	Ke Ma
申请注册联系人电话： Applicant telephone：	+86 131 1695 6823	研究负责人电话： Study leader's telephone：	+86 131 1695 6823
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：	406909561@qq.com	研究负责人电子邮件： Study leader's E-mail：	406909561@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：	云南省昆明市光华街120号	研究负责人通讯地址：	云南省昆明市光华街120号
Applicant address：	120 Guanghua Street, Kunming, Yunnan Province	Study leader's address：	120 Guanghua Street, Kunming, Yunnan Province
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：	云南省中医药大学第一附属医院
Applicant's institution：	The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
研究负责人所在单位：	云南省中医药大学第一附属医院
Affiliation of the Leader：	The First Affiliated Hospital of Yunnan University 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：	XW[2022]伦审字(008)	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：	云南省中医药大学第一附属医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2023-12-11 00:00:00
伦理委员会联系人：	马军
Contact Name of the ethic committee：	Jun Ma
伦理委员会联系地址：	云南省昆明市西山区西园路48号
Contact Address of the ethic committee：	No.48 Xiyuan Road, Xishan District, Kunming, Yunnan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 871 6363 5609	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：

云南省中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

云南省昆明市光华街120号

Primary sponsor's address：

120 Guanghua Street, Kunming, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	云南省	市(区县)：
Country：	china	Province：	yunnan	City：
单位(医院)：	云南省中医药大学第一附属医院	具体地址：	云南省昆明市光华街120号
Institution hospital：	The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine	Address：	120 Guanghua Street, Kunming, Yunnan Province

经费或物资来源：

云南省中医药基础研究联合专项

Source(s) of funding：

Yunnan Provincial Joint Program for Basic Research in Traditional Chinese Medicine

研究疾病：

腹泻型肠易激综合征

Target disease：

Diarrhea-predominant irritable bowel syndrome

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：

验证健脾养肝丸对腹泻型肠易激综合征（肝郁脾虚型）患者临床症状、肠道低度炎症及肠道菌群的改善作用。

Objectives of Study：

Verification of the improvement of clinical symptoms, intestinal low-grade inflammation and intestinal flora in patients with diarrhea-type irritable bowel syndrome (liver-depression and spleen-deficiency phenotype) by Jianpi Yanggan Pills.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Western medical diagnostic criteria.
Referring to the "IBS-D Rome IV Diagnostic Criteria" published by the Rome Commission in 2016, the diagnostic criteria are recurrent abdominal pain, with episodes of at least 1 day per week in the last 3 months, accompanied by 2 or more of the following:
(1)Associated with defecation;
(2) Accompanied by a change in the frequency of defecation;
(3)Accompanied by a change in fecal character (appearance): >1/4 (25%) of the bowel movements are Bristol fecal character type 6 or 7 and <1/4 (25%) of the bowel movements are Bristol fecal character type 1 or 2 (refer to Exhibit 4), the symptoms have been present for at least 6 months prior to the diagnosis and the above diagnostic criteria have been fulfilled in the last 3 months.
2. Diagnostic criteria of Chinese medicine:
The diagnostic criteria of Chinese medicine "diarrhea disease (liver depression and spleen deficiency)" were met;
Diarrhea-type irritable bowel syndrome belongs to the category of "diarrhea disease" in traditional Chinese medicine, and the TCM diagnostic criteria for IBS-D patients included in this study were formulated with reference to the "Expert Consensus Opinions on Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)", which refers to the "Liver Depression and Spleen Deficiency Certificate" of the Diarrhea Disease. 
Primary symptoms: (1) abdominal pain i.e. diarrhea, pain reduction after diarrhea; (2) impatience and irritability.
Secondary symptoms: (1) distension and fullness in both sides; (2) dullness; (3) tiredness.
Tongue and pulse: tongue is pale and fat, may also have teeth marks, moss is thin and white; pulse is stringy. 
Diagnosis: 2 main symptoms, plus 2 secondary symptoms, refer to the tongue and pulse, then diagnosis can be made.
3. The age range of the subjects is between 18-70 years old; 
4. patients with cognitive ability, can actively cooperate to ensure the continuity of treatment and regular follow-up; 
5. colonoscopy (pathological biopsy if necessary), the results suggest no organic lesions, the timeliness of the examination is limited to within the last six months; 
6.fecal routine + fecal occult blood, blood routine, urine routine, liver function, renal function, electrocardiogram did not see obvious abnormalities;
7.Subjects understand the significance of participating in this subject and the possible adverse reactions in clinical research, and voluntarily join the experiment and sign the informed consent, the process of obtaining informed consent should be in accordance with the provisions of the Good Clinical Practice (GCP) for drug clinical trials.

排除标准：

1、已知有药物滥用史或酗酒史者；或对试验药物过敏者； 2、由全身性疾病、中毒、寄生虫感染、恶性肿瘤等原因引起的腹泻； 3、对本药过敏者，或服用其它中药或莫沙必利等影响结果判定者； 4、合并心脑血管、肝、肾、内分泌、自身免疫性疾病和血液系统等器质性疾病，长期服用免疫抑制剂、尘肺、精神疾病患者及吸毒人员； 5、患精神分裂症、癫痫等严重精神疾病或病情危重，难以对该药的有效性和安全性作出确切说明者； 6、妊娠或哺乳期者； 7、虽符合中西医诊断标准但正在参加其他临床研究者； 8、资料不全影响疗效判断者。

Exclusion criteria：

1. Those with a known history of drug abuse or alcoholism; or those who are allergic to the test drug; 2. diarrhea caused by systemic diseases, poisoning, parasitic infections, malignant tumors and other causes; 3. those who are allergic to this drug, or taking other Chinese medicines or mosapride, etc. that affect the determination of the results; 4. Combined cardiovascular, cerebrovascular, hepatic, renal, endocrine, autoimmune diseases and hematological system and other organic diseases, long-term use of immunosuppressants, pneumoconiosis, patients with mental illness and drug addicts; 5. People suffering from schizophrenia, epilepsy and other serious mental illness or critical condition, it is difficult to make a precise statement on the effectiveness and safety of the drug; 6. Pregnant or lactating persons; 7. Those who are participating in other clinical studies although meeting the diagnostic criteria of Chinese and Western medicine; 8. Those whose incomplete information affects the judgment of efficacy.

研究实施时间：

Study execute time：

从 From 2024-04-20 00:00:00至 To 2024-11-20 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-04-20 00:00:00 至 To 2024-10-20 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	experimental group	Sample size：	40
干预措施：	口服健脾养肝丸	干预措施代码：
Intervention：	Oral Jianpi Yanggan Pill	Intervention code：

组别：	对照组	样本量：	40
Group：	control group	Sample size：	40
干预措施：	口服双歧杆菌乳杆菌三联活菌片	干预措施代码：
Intervention：	oral bifidobacterium bifidum Lactobacillus triplex tablets	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南省	市(区县)：	昆明市
Country：	china	Province：	yunnan	City：	Kunming
单位(医院)：	云南省中医药大学第一附属医院	单位级别：	三级
Institution hospital：	The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	腹痛症状评分	指标类型：	主要指标
Outcome：	Abdominal Pain Symptoms 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：	腹泻症状评分	指标类型：	主要指标
Outcome：	Diarrhea Symptoms 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：	肠易激综合征症状严重程度评分	指标类型：	主要指标
Outcome：	Irritable Bowel Syndrome Symptom Severity 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：	中医证候分级	指标类型：	主要指标
Outcome：	Grading of Chinese Medicine 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：	肠道菌群	指标类型：	次要指标
Outcome：	intestinal flora	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	IBS 生活质量问卷评分	指标类型：	次要指标
Outcome：	IBS Quality of Life Questionnaire scores	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	汉密尔顿焦虑评分	指标类型：	次要指标
Outcome：	Hamilton Anxiety 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：	血清炎症因子	指标类型：	次要指标
Outcome：	serum inflammatory factor	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：	粪便	组织：
Sample Name：	faeces	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：	血液	组织：
Sample Name：	hematology	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：

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	18	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）：

事先通过使用SPSS 24.0软件中随机数字生成器功能，将1-80的连续数字随机平均分为治疗组和对照组；依照患者初次就诊时间的先后顺序，对确定纳入患者进行编号，根据患者编号所在组别，对患者采取不同的治疗手段。

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

By using the random number generator function in SPSS 24.0 software, the consecutive numbers from 1 to 80 were randomly divided into the treatment group and the control group; according to the order of the time of the patients' first visit to the clinic, the patients were numbered, and according to the group in which the patient number was located, the patients were treated by different therapeutic means .

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：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	实验完成后6个月内公开在百度云网盘
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Experiment within 6 months after the completion of the public in baidu cloud network location
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：	数据采集主要包括纸质版的病例记录表（CRF表）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection mainly includes the paper case record form (CRF form)
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2024-04-18 11:46:53