黄连汤“昼三夜二”分时给药改善脓毒症相关CCI肌营养不良的多中心临床对照研究

注册号:

Registration number:

ITMCTR2024000045

最近更新日期:

Date of Last Refreshed on:

2024-04-16

注册时间:

Date of Registration:

2024-04-16

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

黄连汤“昼三夜二”分时给药改善脓毒症相关CCI肌营养不良的多中心临床对照研究

Public title:

A multicenter controlled clinical trial on the improvement of sepsis-associated CCI muscular dystrophy by time-sharing administration(Day-3-Night-2) of Huanglian Decoction

注册题目简写:

English Acronym:

研究课题的正式科学名称:

黄连汤“昼三夜二”分时给药改善脓毒症相关CCI肌营养不良的多中心临床对照研究

Scientific title:

A multicenter controlled clinical trial on the improvement of sepsis-associated CCI muscular dystrophy by time-sharing administration(Day-3-Night-2) of Huanglian Decoction

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:

邵冰

研究负责人:

蒋华

Applicant:

Shao bing

Study leader:

Jiang hua

申请注册联系人电话:

Applicant telephone:

+86 178 5616 6592

研究负责人电话:

Study leader's telephone:

+86 133 8277 4099

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:

pancake1111@163.com

研究负责人电子邮件:

Study leader's E-mail:

yfy0096@njucm.edu.cn

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:

江苏省南京市秦淮区汉中路155号

研究负责人通讯地址:

江苏省南京市秦淮区汉中路155号

Applicant address:

No.155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu Province, China

Study leader's address:

No.155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu 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:

南京中医药大学

Applicant's institution:

Nanjing 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:

2023NL-097-02

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:

南京中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/5/4 0:00:00

伦理委员会联系人:

王卯

Contact Name of the ethic committee:

Wang mao

伦理委员会联系地址:

江苏省南京市秦淮区汉中路155号

Contact Address of the ethic committee:

No.155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 86560515

伦理委员会联系人邮箱:

Contact email of the ethic committee:

2773582637@qq.com

研究实施负责(组长)单位:

南京中医药大学附属医院 江苏省中医院

Primary sponsor:

Jiangsu Provincial Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号

Primary sponsor's address:

No.155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京中医药大学附属医院 江苏省中医院

具体地址:

江苏省南京市秦淮区汉中路155号

Institution
hospital:

Jiangsu Provincial Hospital of Chinese Medicine

Address:

No.155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu Province, China

经费或物资来源:

2022年度省中医药科技发展计划项目

Source(s) of funding:

2022 Provincial TCM Science and Technology Development Program Projects

研究疾病:

脓毒症相关慢重症

研究疾病代码:

Target disease:

Sepsis-related Chronic Care Illnesses

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:

其它

Others

研究目的:

论证黄连汤“昼三夜二”分时服药,可延缓脓毒症相关CCI患者的肌营养不良,缩短ICU住院时间和提高总体临床预后。

Objectives of Study:

To demonstrate that HuanglianDecoction's "Day-3-Night-2" time-sharing can delay myotonic dystrophy, shorten the duration of ICU stay, and improve the overall clinical prognosis of patients with sepsis-associated CCI.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

纳入标准 ①符合脓毒症相关CCI诊断标准者。 ②年龄在18~85岁之间,性别不限。 ③接受肠内营养治疗。 ④无严重代谢性疾病和消化道其他疾病,如放射性肠炎、断肠综合征等。 ⑤知情同意,志愿受试。

Inclusion criteria

Inclusion Criteria ① Those who met the diagnostic criteria of sepsis-related CCI. ② Age between 18 and 85 years old, gender is not limited. ③ Receive enteral nutrition therapy. ④No serious metabolic disease and other diseases of the digestive tract, such as radiation enteritis and broken bowel syndrome. ⑤ Informed consent and volunteer to be tested.

排除标准:

排除标准 ① ICU滞留时间小于14天。 ②机械性肠梗阻、消化道大出血。 ③拒绝或无法进行肠内营养治疗。 ④频临死亡或复苏失败、无法配合或拒绝完成相关检查。 ⑤娠期、哺乳期妇女。 ⑥正在参加其他药物临床试验的患者。

Exclusion criteria:

Exclusion Criteria ① ICU stay less than 14 days. ② Mechanical intestinal obstruction, gastrointestinal hemorrhage. ③ Refusal or inability to perform enteral nutrition therapy. Frequent death or failure of resuscitation, inability to cooperate or refusal to complete the relevant examination. ⑤ Pregnant and lactating women. ⑥ Patients who are participating in clinical trials of other drugs.

研究实施时间:

Study execute time:

From 2023-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2023-09-01

To      2025-06-30

干预措施:

Interventions:

组别:

黄连汤组

样本量:

40

Group:

Huanglian Decoction Group

Sample size:

干预措施:

“昼三夜二”法给予肠内营养液,黄连汤服用时间同肠内营养液服用时间。其他时间点不予以鼻饲。

干预措施代码:

Intervention:

Enteral nutrient solution was given by the method of"Day 3 Night 2".Huanglian Decoction was given at the same time as the enteral nutrient solution. Nasogastric feeds were not given at the other time points.

Intervention code:

组别:

观察组

样本量:

40

Group:

Observation Group

Sample size:

干预措施:

“昼三夜二”法给予肠内营养液。其他时间点不予以鼻饲。

干预措施代码:

Intervention:

"Day 3 Night 2" method of administration of enteral nutritional solution. Nasal gavage was not given at other time points.

Intervention code:

组别:

对照组

样本量:

40

Group:

Control Group

Sample size:

干预措施:

持续泵入肠内营养液。

干预措施代码:

Intervention:

Continuous pumping of enteral nutrition solution.

Intervention code:

组别:

黄连汤对照组

样本量:

40

Group:

Huanglian Decoction Control Group

Sample size:

干预措施:

“昼三夜二”法给予肠内营养液。他时间点不予以鼻饲。常规时间服用黄连汤。

干预措施代码:

Intervention:

" Day 3 Night 2 " method was given enteral nutrition solution.Nasal feeding was not given at other time points. Huanglian Decoction was given at regular time.

Intervention code:

样本总量 Total sample size : 160

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省第二中医院

单位级别:

三甲

Institution/hospital:

Jiangsu Second Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中西医结合医院

单位级别:

三甲

Institution/hospital:

Jiangsu Combined Traditional Chinese and Western Medicine Hospital

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京市中医院

单位级别:

三甲

Institution/hospital:

Nanjing Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院江北分院

单位级别:

二乙

Institution/hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine Jiangbei Branch

Level of the institution:

Secondary B hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京中医药大学附属医院 江苏省中医院

单位级别:

三甲

Institution/hospital:

Jiangsu Provincial Hospital of Chinese Medicine

Level of the institution:

Tertiary hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院溧阳分院

单位级别:

二甲

Institution/hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine Liyang Branch

Level of the institution:

Secondary hospital

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院宿迁分院

单位级别:

三甲

Institution/hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine Suqian Branch

Level of the institution:

Tertiary hospital

测量指标:

Outcomes:

指标中文名:

SOFA评分

指标类型:

次要指标

Outcome:

SOFA 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:

血清营养指标:血红蛋白、白蛋白、前白蛋白和睾酮

指标类型:

次要指标

Outcome:

Serum nutritional indicators: haemoglobin, albumin, prealbumin and testosterone

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APACHE II评分

指标类型:

次要指标

Outcome:

APACHE II 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:

B超测量下的膈肌指标(厚度、变化率、移动度)

指标类型:

主要指标

Outcome:

Diaphragmatic indicators (thickness, rate of change, mobility) measured by ultrasound

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天和90天生存率

指标类型:

次要指标

Outcome:

28- and 90-day survival rates

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NUTRIC评分

指标类型:

次要指标

Outcome:

NUTRIC 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:

B超测量下的股中肌、股直肌和胫骨前肌肉厚度,股直肌横截面积

指标类型:

主要指标

Outcome:

Thickness of the median femoral, rectus femoris, and tibialis anterior muscles measured by ultrasound, and cross-sectional area of the rectus femoris muscle

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

B超测量下的腹腔内脂肪厚度,包括皮下脂肪及内脏脂肪厚度

指标类型:

主要指标

Outcome:

Ultrasound-measured intra-abdominal fat thickness, including subcutaneous and visceral fat thicknesses

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NRS2002评分

指标类型:

次要指标

Outcome:

NRS2002 score

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:

Faecal

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 85
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):

使用Excel建立随机数字表,受试者按照入组的先后顺序分别对应随机数字,实现分组。

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

A table of random numbers was created using Excel, and subjects were grouped according to the order in which they entered the group corresponding to the random numbers, respectively.

盲法:

Blinding:

None

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):

江苏省中医院临床研究数据采集及管理系统 https://edc.jshtcm.com/

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

Clinical Research Data Collection and Management System for Jiangsu Hospital of Traditional Chinese Medicine https://edc.jshtcm.com/

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:

江苏省中医院临床研究数据采集及管理系统 https://edc.jshtcm.com/

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

Clinical Research Data Collection and Management System for Jiangsu Hospital of Traditional Chinese Medicine https://edc.jshtcm.com/

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