一项评价不同剂量枳实总黄酮片对肠传输功能改善的有效性和安全性的多中心、随机、双盲、安慰剂平行对照试验

注册号:

Registration number:

ITMCTR2024000496

最近更新日期:

Date of Last Refreshed on:

2024-09-26

注册时间:

Date of Registration:

2024-09-26

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

一项评价不同剂量枳实总黄酮片对肠传输功能改善的有效性和安全性的多中心、随机、双盲、安慰剂平行对照试验

Public title:

The evaluatetion of the efficacy and safety of Aurantii Fructus Immaturus flavonoid tablets on the improvement of intestinal transport function with different dose: A multicentre randmoized double-blind placebo-parallel controlled trial

注册题目简写:

枳实总黄酮片对肠传送功能的改善

English Acronym:

Improvement of intestinal transport function by Aurantii Fructus Immaturus flavonoid tablets

研究课题的正式科学名称:

一项评价不同剂量枳实总黄酮片对肠传输功能改善的有效性和安全性的多中心、随机、双盲、安慰剂平行对照试验

Scientific title:

The evaluatetion of the efficacy and safety of Aurantii Fructus Immaturus flavonoid tablets on the improvement of intestinal transport function with different dose: A multicentre randmoized double-blind placebo-parallel controlled trial

研究课题的正式科学名称简写:

枳实总黄酮片对肠传送功能的改善

Scientific title acronym:

Improvement of intestinal transport function by Aurantii Fructus Immaturus flavonoid tablets

研究课题代号(代码):

Study subject ID:

ZSZH01

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:

白涛

研究负责人:

侯晓华

Applicant:

Tao Bai

Study leader:

Xiaohua Hou

申请注册联系人电话:

Applicant telephone:

15802734363

研究负责人电话:

Study leader's telephone:

027-8572605

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:

drbaitao@126.com

研究负责人电子邮件:

Study leader's E-mail:

houxh@hust.edu.cn

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

https://www.whuh.com/?userinfo=PgJP6Rw7oBgwafRcNYDuZ0EVwtP1KrQfFap0nPa8vSi65itDG7wp4g

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:

湖北省武汉市江汉区解放大道1277号协和医院

研究负责人通讯地址:

湖北省武汉市江汉区解放大道1277号协和医院

Applicant address:

Union Hospital 1277 Jiefang Avenue Jianghan District Wuhan City Hubei Province China

Study leader's address:

Union Hospital 1277 Jiefang Avenue Jianghan District Wuhan City Hubei 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:

华中科技大学同济医学院附属协和医院

Applicant's institution:

Union Hospital Tongji Medical College Huazhong University of Science and Technology

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:

UHCT240688

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee Union Hospital Tongji Medical College Huazhong University of Science and Technology

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/6 0:00:00

伦理委员会联系人:

褚圆圆

Contact Name of the ethic committee:

Yuanyuan Chu

伦理委员会联系地址:

湖北省武汉市江汉区解放大道1277号协和医院

Contact Address of the ethic committee:

Union Hospital 1277 Jiefang Avenue Jianghan District Wuhan City Hubei Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

027-85726375

伦理委员会联系人邮箱:

Contact email of the ethic committee:

whunionlunli@126.com

研究实施负责(组长)单位:

华中科技大学同济医学院附属协和医院

Primary sponsor:

Union Hospital Tongji Medical College Huazhong University of Science and Technology

研究实施负责(组长)单位地址:

湖北省武汉市江汉区解放大道1277号协和医院

Primary sponsor's address:

Union Hospital 1277 Jiefang Avenue Jianghan District Wuhan City Hubei 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

湖北省武汉市江汉区解放大道1277号

Institution
hospital:

Union Hospital Tongji medical college Huazhong University of Science and Technology

Address:

Union Hospital 1277 Jiefang Avenue Jianghan District Wuhan City Hubei Province China

经费或物资来源:

企事业单位委托项目(江西青峰药业有限公司)并资助

Source(s) of funding:

Jiangxi Qingfeng Pharmaceutical Trading Co. Ltd.

研究疾病:

慢性便秘

研究疾病代码:

Target disease:

Chronic constipation

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:

评价枳实总黄酮片3片(tid.)、6片(tid.)对肠传输功能延迟的改善作用。同时评价枳实总黄酮片3片(tid.)、6片(tid.)治疗功能性便秘的有效性,以及评价枳实总黄酮片3片(tid.)、6片(tid.)治疗功能性便秘的安全性。

Objectives of Study:

Evaluate the improvement of delayed intestinal transmission function by Aurantii Fructus Immaturus flavonoid tablets 3 tablets (tid.) and 6 tablets (tid.). To also evaluate the efficacy of Aurantii Fructus Immaturus flavonoid tablets 3 tablets (tid.) 6 tablets (tid.) in the treatment of functional constipation as well as to evaluate the safety of Aurantii Fructus Immaturus flavonoid tablets 3 tablets (tid.) 6 tablets (tid.) in the treatment of functional constipation.

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: 自愿参加并签署知情同意书 2: 年龄≥18岁的男性或女性受试者 3: 研究开始时女性受试者未怀孕或处于哺乳期, 研究期间男性和女性受试者避孕 4: 筛选前3年内三级医院结肠镜检查正常, 或研究者判断为轻度异常但不能解释便秘症状者。受试者如有肠息肉,息肉状态应为无需立即治疗(需要治疗标准:息肉直接>0.5cm或数量>3个, 或有明显的绒毛组织等), 肠道息肉摘除者至少1月后无出血情况可参加本研究 5: 符合罗马IV功能性便秘诊断标准: 诊断前症状出现至少6个月,近3个月符合以下标准(罗马IV功能性便秘的修订诊断标准要求)。受试者报告在不用泻剂时很少出现稀粪,不符合肠易激综合征的罗马IV诊断标准;不适用手法辅助排便(如用手指协助排便、盆地支持排便); 报告每周自发排便少于3次。且受试者报告以下情况至少两种: 1/4 (25%)以上的排便感到费力、1/4 (25%)以上的排便为干球粪或硬粪(Bristol粪便性状量表1-2型)、1/4 (25%)以上的排便有不尽感、1/4 (25%)以上的排便有肛门直肠梗阻/堵塞感 6: 肠道传输功能检测确定为肠道传输功能降低 7: 受试者治疗前14天内评估至少完成10天的筛选期日记卡 8: 受试者同意从签署知情同意到末次访视期间,不做任何新的生活方式的重大改变

Inclusion criteria

1: Voluntary participation and signed informed consent 2: Male or female subjects ≥18 years of age 3: Female subjects who are not pregnant or breastfeeding at the start of the study and male and female subjects who are using contraception during the study 4: Normal colonoscopy at a tertiary care hospital within 3 years prior to screening or those with mild abnormalities in the judgement of the investigator that do not explain the symptoms of constipation. Subjects who have intestinal polyps with a polyp status that does not require immediate treatment (criteria for needing treatment: polyps directly >0.5cm or number >3 or visible villous tissue etc.) and intestinal polyp removers who have had no bleeding for at least 1 month are eligible to participate in the study 5: Meet the Rome IV diagnostic criteria for functional constipation: symptoms for at least 6 months prior to diagnosis and the following criteria for the last 3 months (as required by the revised Rome IV diagnostic criteria for functional constipation). The subject reports few loose stools when laxatives are not used which does not meet the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS); does not use manoeuvre-assisted defecation (e.g. finger-assisted defecation pelvic support for defecation); and reports spontaneous defecation less than 3 times per week. Subjects report at least two of the following: 1/4 (25%) or more straining to pass stools 1/4 (25%) or more dry bulbous or hard stools (Bristol Stool Profile Scale type 1-2) 1/4 (25%) or more incomplete stools 1/4 (25%) or more anorectal obstruction/blockages 6: Decreased intestinal transport function as determined by intestinal transport function testing 7: Subject completes a screening period diary card for at least 10 days as assessed within 14 days prior to treatment 8: Subject agrees not to make any new major lifestyle changes between the time of signing informed consent and the final visit

排除标准:

1: 已知对研究药物或补救药物过敏或禁忌 2: 存在当前不能解释且临床显著的报警症状 3: 已知继发性因素引起的便秘(多发性硬化、帕金森病、脊髓损伤等) 4: 已知的肠道器质性疾病(如:炎症性肠病、肠梗阻等) 5: 结肠传输试验显示为出口梗阻型 6: 受试者有腹痛、腹部不适的其他慢性疾病可能干扰疗效评估(如:慢性胰腺炎、子宫内膜异位等) 7: 活动期消化性溃疡 8: 接受过胃肠道手术 9: 存在恶性肿瘤病史 10: 酒精滥用或严重的精神疾患 11: 已知的临床有意义的肝肾功能损伤、活动性病毒性肝炎、糖尿病周围神经病变等器质性疾病 12: 受试者在首次服药前72小时内使用了补救药物(比沙可啶)或任何其他泻剂、栓剂或灌肠 13: 受试者报告在为期2周的治疗前评估期的两周中的任何一周内,使用补救药物比沙可啶≥3天 14: 其他研究者认为不适宜参与研究的受试者

Exclusion criteria:

1: Known allergy or contraindication to the study drug or remedial drug 2: Presence of currently unexplained and clinically significant alarm symptoms 3: Known constipation due to secondary factors (multiple sclerosis Parkinson's disease spinal cord injury etc.) 4: Known organic diseases of the intestine (e.g. inflammatory bowel disease intestinal obstruction etc.) 5: Colonic transport test showing an outlet obstruction type 6: Other chronic conditions in which the subject has abdominal pain abdominal discomfort that may interfere with efficacy assessment (e.g. chronic pancreatitis endometriosis etc.) 7: Active peptic ulcer 8: Previous gastrointestinal surgery 9: Presence of a history of malignancy 10: Alcohol abuse or severe psychiatric disorders 11: Known clinically significant liver or renal impairment active viral hepatitis diabetic peripheral neuropathy and other organic diseases 12: Subject has used a remedial medication (bisacodyl) or any other laxative suppository or enema within 72 hours prior to the first dose of medication 13: Subject reported use of the remedial drug bisacodyl for ≥3 days during any of the two weeks of the 2-week pre-treatment assessment period 14: Subjects deemed by the investigator to be unsuitable to participate in the study

研究实施时间:

Study execute time:

From 2024-10-01

To      2026-10-01

征募观察对象时间:

Recruiting time:

From 2024-10-01

To      2026-10-01

干预措施:

Interventions:

组别:

枳实总黄酮片低剂量组

样本量:

20

Group:

Aurantii Fructus Immaturus flavonoid tablets low dose group

Sample size:

干预措施:

枳实总黄酮片3片(tid.)

干预措施代码:

Intervention:

Aurantii Fructus Immaturus flavonoid tablets 3 tablets (tid.)

Intervention code:

组别:

枳实总黄酮片高剂量组

样本量:

20

Group:

Aurantii Fructus Immaturus flavonoid tablets high dose group

Sample size:

干预措施:

枳实总黄酮片6片(tid.)

干预措施代码:

Intervention:

Aurantii Fructus Immaturus flavonoid tablets 6 tablets (tid.)

Intervention code:

组别:

安慰剂组

样本量:

20

Group:

Placebo 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 : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属邵逸夫医院

单位级别:

三甲医院

Institution/hospital:

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属协和医院

单位级别:

三甲医院

Institution/hospital:

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjing

City:

单位(医院):

天津医科大学总医院

单位级别:

三甲医院

Institution/hospital:

Tianjin Medical University General Hospital

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

山东

市(区县):

滨州

Country:

China

Province:

Shandong

City:

Binzhou

单位(医院):

滨州医学院附属医院

单位级别:

三甲医院

Institution/hospital:

Affiliated Hospital of Binzhou Medical College

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

湖北

市(区县):

宜昌

Country:

China

Province:

Hubei

City:

Yichang

单位(医院):

宜昌市中心人民医院

单位级别:

三甲医院

Institution/hospital:

Yichang Central People's Hospital

Level of the institution:

Tertiary hospita

国家:

中国

省(直辖市):

湖北

市(区县):

咸宁

Country:

China

Province:

Hubei

City:

Xianning

单位(医院):

咸宁市中心医院

单位级别:

三甲医院

Institution/hospital:

Xianning Central Hospital

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

江西

市(区县):

赣州

Country:

China

Province:

Jiangxi

City:

Ganzhou

单位(医院):

赣南医学院第一附属医院

单位级别:

三甲医院

Institution/hospital:

The First Affiliated Hospital of Gannan Medical College

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

湖北

市(区县):

仙桃

Country:

China

Province:

Hubei

City:

Xiantao

单位(医院):

仙桃市第一人民医院

单位级别:

三甲医院

Institution/hospital:

Xiantao First People's Hospital

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省中医药

单位级别:

三甲医院

Institution/hospital:

Zhejiang Provincial Traditional Chinese Medicine

Level of the institution:

Tertiary hospita

国家:

中国

省(直辖市):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

南昌大学第一附属医院

单位级别:

三甲医院

Institution/hospital:

The First Affiliated Hospital of Nanchang University

Level of the institution:

Tertiary hospita

测量指标:

Outcomes:

指标中文名:

生活质量

指标类型:

次要指标

Outcome:

Quality of life

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规检查结果

指标类型:

副作用指标

Outcome:

Results of routine blood tests

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便性状

指标类型:

次要指标

Outcome:

Stool consistency

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补救药物的使用

指标类型:

次要指标

Outcome:

Use of remedial medicines

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能检查结果

指标类型:

副作用指标

Outcome:

Liver and kidney function test results

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便频率(CSBM、SBM)

指标类型:

次要指标

Outcome:

frequency of defecation (CSBM SBM)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

副作用指标

Outcome:

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:

首次SBM/CSBM

指标类型:

次要指标

Outcome:

First SBM/CSBM

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗满意度

指标类型:

次要指标

Outcome:

Treatment satisfaction

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结肠传输时间

指标类型:

主要指标

Outcome:

Colonic transit time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便秘应答率(CSBM+1)

指标类型:

次要指标

Outcome:

Response rate for constipation (CSBM+1)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图结果

指标类型:

副作用指标

Outcome:

Electrocardiogram results

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标

Outcome:

Adverse events

Type:

Adverse events

测量时间点:

研究全过程

测量方法:

受试者报告、体格检查及实验室检查

Measure time point of outcome:

The whole process of research

Measure method:

Subject report physical examination and laboratory tests

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:

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 200
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

由统计单位应用SAS(9.4或更高版本)产生随机数列

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

Generation of random number series by statistical units applying SAS (version 9.4 or higher)

盲法:

双盲(对受试者和研究者均隐藏分组)

Blinding:

Double-blind (hidden groups for both subjects and investigators)

是否共享原始数据:

IPD sharing:

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):

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

NA

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:

病历记录表及电子采集和管理系统

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

Electronic Data Capture and Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统