运脾化湿清肺汤治疗脾虚型特应性皮炎及对苦味受体相关蛋白调控的临床研究

注册号:

Registration number:

ITMCTR2024000143

最近更新日期:

Date of Last Refreshed on:

2024-07-30

注册时间:

Date of Registration:

2024-07-30

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

运脾化湿清肺汤治疗脾虚型特应性皮炎及对苦味受体相关蛋白调控的临床研究

Public title:

Clinical Study on the Treatment of Spleen Deficiency Syndrome's Atopic Dermatitis with Yunpi Huashi Qingfei Decoction and Its Regulation on Bitter Taste Receptor

注册题目简写:

English Acronym:

研究课题的正式科学名称:

运脾化湿清肺汤治疗脾虚型特应性皮炎及对苦味受体相关蛋白调控的临床研究

Scientific title:

Clinical Study on the Treatment of Spleen Deficiency Syndrome's Atopic Dermatitis with Yunpi Huashi Qingfei Decoction and Its Regulation on Bitter Taste Receptor

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:

徐晓倩

研究负责人:

宋瑜

Applicant:

Xu Xiaoqian

Study leader:

Song Yu

申请注册联系人电话:

Applicant telephone:

13761525444

研究负责人电话:

Study leader's telephone:

13501752835

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:

1071944125@qq.com

研究负责人电子邮件:

Study leader's E-mail:

sonyui@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:

上海市徐汇区宛平南路725号

研究负责人通讯地址:

上海市徐汇区宛平南路725号

Applicant address:

No.725, Wanping South Road, Xuhui District, Shanghai

Study leader's address:

No.725, Wanping South Road, Xuhui District, Shanghai

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:

上海中医药大学附属龙华医院

Applicant's institution:

Longhua Hospital Shanghai University of Traditional 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:

2024LCSY029

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:

上海中医药大学附属龙华医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/25 0:00:00

伦理委员会联系人:

陈晓云

Contact Name of the ethic committee:

Chen Xiaoyun

伦理委员会联系地址:

上海市徐汇区宛平南路725号

Contact Address of the ethic committee:

No.725, Wanping South Road, Xuhui District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

64385700

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lhtcmirb@sina.com

研究实施负责(组长)单位:

上海中医药大学附属龙华医院

Primary sponsor:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市徐汇区宛平南路725号

Primary sponsor's address:

No.725, Wanping South Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

中国

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

具体地址:

上海市徐汇区宛平南路725号

Institution
hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Address:

No.725, Wanping South Road, Xuhui District, Shanghai

经费或物资来源:

上海中医药大学附属龙华医院

Source(s) of funding:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

研究疾病:

特应性皮炎

研究疾病代码:

Target disease:

Atopic dermatitis

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:

探讨运脾化湿清肺汤对脾虚型特应性皮炎患者的整体疗效以及治疗前后对苦味受体相关蛋白调控的影响。

Objectives of Study:

To investigate the overall curative effect of Yunpi Huashi Qingfei Decoction on patients with spleen deficiency atopic dermatitis and the influence of the regulation of bitter receptor related proteins before and after treatment.

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)符合西医Williams诊断标准。 2)符合中医脾虚证诊断标准。 3)皮损严重程度属于轻中度(ESAI≤21分)。 4)患者年龄在8岁以上,60岁以下,性别、民族不限。 5)对本临床项目知情同意(若患者为未成年,则需取得本人及法定监护人同意),且配合随访及研究者。

Inclusion criteria

1) Conforming to the Western medicine Williams diagnostic criteria. 2) Conforming to the diagnostic criteria of spleen deficiency syndrome in Traditional Chinese Medicine. 3) The severity of skin lesions belongs to mild to moderate (ESAI ≤ 21 points). 4) Patients' age is above 8 years old and below 60 years old, regardless of gender and ethnicity. 5) Giving informed consent to this clinical project (if the patient is a minor, the consent of the patient and the legal guardian is required), and cooperating with the follow-up and researchers.

排除标准:

1)有严重内科、外科疾病患者; 2)女性正在妊娠或准备妊娠及处于哺乳期的女性; 3)有精神类疾病病史者; 4)近2周内使用过TCS、TCI等治疗皮肤病药物的患者; 5)近二周内使用免疫抑制剂、抗生素、生物制剂治疗者; 6)对试验药物中任何成分过敏的患者。

Exclusion criteria:

1) Patients with severe internal medicine or surgical diseases; 2) Females who are pregnant or preparing for pregnancy and those in the lactation period; 3) Patients with a history of mental disorders; 4) Patients who have used TCS, TCI and other drugs for treating skin diseases within the recent two weeks; 5) Patients who have used immunosuppressants, antibiotics and biological agents for treatment within the recent two weeks; 6) Patients allergic to any component of the experimental drug.

研究实施时间:

Study execute time:

From 2024-04-25

To      2025-07-31

征募观察对象时间:

Recruiting time:

From 2024-04-25

To      2025-07-31

干预措施:

Interventions:

组别:

安慰剂对照组

样本量:

24

Group:

Placebo control group

Sample size:

干预措施:

安慰剂颗粒

干预措施代码:

Intervention:

Placebo granule

Intervention code:

组别:

运脾化湿清肺汤试验组

样本量:

48

Group:

Yunpi Huashi Qingfei decoction experimental group

Sample size:

干预措施:

运脾化湿清肺汤中药颗粒

干预措施代码:

Intervention:

Yunpi Huashi Qingfei decoction granule

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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

单位级别:

三甲

Institution/hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

Urine routine test

Type:

Adverse events

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标

Outcome:

Liver and kidney function test

Type:

Adverse events

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

Measure method:

指标中文名:

NRS评分

指标类型:

次要指标

Outcome:

NRS Score

Type:

Secondary indicator

测量时间点:

第0周,第1周,第2周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 1, week 2, week 4

Measure method:

指标中文名:

Easi评分

指标类型:

主要指标

Outcome:

Easi Score

Type:

Primary indicator

测量时间点:

第0周,第1周,第2周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 1, week 2, week 4

Measure method:

指标中文名:

中医证候评分

指标类型:

次要指标

Outcome:

TCM syndrome score

Type:

Secondary indicator

测量时间点:

第0周,第1周,第2周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 1, week 2, week 4

Measure method:

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

Blood routine test

Type:

Adverse events

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

Measure method:

指标中文名:

NOS

指标类型:

次要指标

Outcome:

NOS

Type:

Secondary indicator

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

Measure method:

指标中文名:

TAS2R38

指标类型:

次要指标

Outcome:

TAS2R38

Type:

Secondary indicator

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

Measure method:

指标中文名:

NO

指标类型:

次要指标

Outcome:

NO

Type:

Secondary indicator

测量时间点:

第0周,第4周

测量方法:

Measure time point of outcome:

Week 0, week 4

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

使用后保存

说明

Fate of sample 

Preservation after use

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 8
Min age years
最大 60
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):

研究者按照随机数字表法产生随机序列

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

Researchers generate random sequences according to a random number table method

盲法:

由专人按盲底对药品进行分装编盲,为每个受试者分配一个药盒,药盒中包含治疗期内用药,药盒的标签上写上编号,盒内所有药品的标签也写上相同编号,并为每个病例准备一个应急信件,信封标有病人的药物编号,密封的信纸内注明了该病例的所属组别,供紧急揭盲时用。施盲对象:符合标准的特应性皮炎患者及研究者本人。

Blinding:

The medicine will be sorted according to the blind bottom by a specially-assigned person, and each subject will be assigned a medicine box, which contains drugs used during the treatment period. The label of the medicine box shall be numbered, and the label of all drugs in the box shall also be numbered. An emergency letter shall be prepared for each case, with the envelope marked with the patient's drug number and the group of the case indicated on the sealed letter paper for emergency blinding.Blind subjects: atopic dermatitis patients who met the criteria and the researcher himself.

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):

None

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

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

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):

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