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Evaluation of therapeutic effect of auricular point therapy combined with traditional Chinese medicine on psoriasis complicated with insomnia

注册号：

Registration number：

ITMCTR2025000574

最近更新日期：

Date of Last Refreshed on：

2025-03-22

注册时间：

Date of Registration：

2025-03-22

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

耳穴疗法联合中药治疗银屑病合并失眠的疗效评价

Public title：

Evaluation of therapeutic effect of auricular point therapy combined with traditional Chinese medicine on psoriasis complicated with insomnia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳穴疗法联合中药治疗银屑病合并失眠的疗效评价

Scientific title：

Evaluation of therapeutic effect of auricular point therapy combined with traditional Chinese medicine on psoriasis complicated with insomnia

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：

官科汶

研究负责人：

卢传坚

Applicant：

Kewen Guan

Study leader：

Chuanjian Lu

申请注册联系人电话：

Applicant telephone：

+86 15815618940

研究负责人电话：

Study leader's telephone：

+86 13822250116

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：

993614762@qq.com

研究负责人电子邮件：

Study leader's E-mail：

lcj@gzucm.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：

广东省广州市越秀区大德路111号

研究负责人通讯地址：

广东省广州市越秀区大德路111号

Applicant address：

111 Dade Road Yuexiu District Guangzhou Guangdong China

Study leader's address：

111 Dade Road Yuexiu District Guangzhou Guangdong 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：

广州中医药大学第二临床医学院

Applicant's institution：

The Second School of Clinical Medicine of Guangzhou 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：

YF-2024-264-02

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：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/26 0:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Xiaoyan Li

伦理委员会联系地址：

广东省广州市越秀区大德路111号

Contact Address of the ethic committee：

111 Dade Road Yuexiu District Guangzhou Guangdong China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 81887233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

15913123537@163.com

研究实施负责（组长）单位：

广东省中医院

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College Guangzhou University of Traditional Chinese Medicine)

研究实施负责（组长）单位地址：

广东省广州市越秀区大德路111号

Primary sponsor's address：

111 Dade Road Yuexiu District Guangzhou Guangdong 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东省中医院

具体地址：

广东省广州市越秀区大德路111号

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College Guangzhou University of Traditional Chinese Medicine)

Address：

111 Dade Road Yuexiu District Guangzhou Guangdong China

经费或物资来源：

研究生课题

Source(s) of funding：

postgraduate project

研究疾病：

轻中度寻常型银屑病伴失眠

研究疾病代码：

Target disease：

mild-to-moderate psoriasis vulgaris complicated with insomnia

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：

初步评估耳穴压丸联合中药固本祛湿化瘀方治疗银屑病合并失眠的临床疗效和安全性，以及研究方案的可行性，以便优化正式试验的研究设计。

Objectives of Study：

To explore the feasibility and acceptability of the trial protocol as well as collect preliminary data on the efficacy and safety of auricular point pressing seeds combined with oral traditional Chinese medicine granules（Gubenqushihuayu granules) for participants with mild-to-moderate psoriasis vulgaris complicated with insomnia.Results from this pilot trial will be used to optimise the design of a future full-scale study.

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年龄18-75岁，男女不限。 ②符合轻中度寻常型银屑病的诊断标准（PASI＜10分，且BSA＜10%）。 ③符合失眠症的诊断标准，PSQI＞7。 ④患者对本研究知情并同意，自愿参与，签署知情同意书者。

Inclusion criteria

① Age 18-75 years old male or female. ② It meets the diagnostic criteria of mild to moderate psoriasis vulgaris (PASI < 10 BSA < 10%). ③ Meet the diagnostic criteria of insomnia PSQI > 7. ④ Patients informed and agreed to this study voluntarily participated and signed informed consent form.

排除标准：

①妊娠、哺乳期妇女，或研究周期内计划妊娠者。 ②心理测量量表SAS标准分＞50分或SDS标准分＞53分，或合并其他精神疾病的患者。 ③合并有呼吸系统、循环系统、皮肤的严重原发性疾病，常规用药无法控制的患者；合并严重感染、结核和肝炎等传染病史、淋巴细胞增生、造血系统异常、肿瘤、重度肾功能不全的患者；合并有严重水、电解质及酸碱平衡紊乱的患者；合并原发或继发性免疫缺陷及超敏患者；合并严重精神类疾病患者。 ④有明显严重躯体症状影响睡眠质量者，如骨关节疼痛、睡眠呼吸暂停、不宁腿等。 ⑤1周内使用中药或中成药、局部疗法（抗生素、激素类外用药、维生素 D3 类似物、钙调磷酸酶抑制剂、角质剥脱剂等）治疗者；2周内使用口服类系统治疗（甲氨蝶呤、阿维 A、环孢素 A、富马酸酯等）或紫外光治疗者；5个生物制剂半衰期之内的治疗者。 ⑥已知对本研究中所用药物、材料过敏及含有相关药物成分过敏的患者。 ⑦耳穴局部皮肤具有银屑病皮损、脓肿、溃破、感染、冻疮、瘢痕者。 ⑧正在参加其它药物临床试验者或4周内参加过其它临床试验者。 ⑨研究者认为不适合纳入的患者。

Exclusion criteria：

① Pregnant and lactating women or those who plan pregnancy during the study period. ② Patients with SAS standard score > 50 or SDS standard score > 53 in psychometric scale or patients complicated with other mental diseases. ③ Patients with serious primary diseases of respiratory system circulatory system and skin that can't be controlled by routine medication; Patients with severe infection history of infectious diseases such as tuberculosis and hepatitis lymphocyte proliferation abnormal hematopoietic system tumor and severe renal insufficiency; Patients with severe water electrolyte and acid-base balance disorder; Patients with primary or secondary immunodeficiency and hypersensitivity; Patients with severe mental illness. ④ Those who have obvious serious physical symptoms that affect sleep quality such as joint pain sleep apnea restless legs etc. ⑤ Patients who are treated with traditional Chinese medicine or Chinese patent medicine and local therapy (antibiotics hormones for external use vitamin D3 analogues calcineurin inhibitors exfoliating agents etc.) within one week; Oral systemic therapy (methotrexate Avia cyclosporine A fumarate etc.) or ultraviolet light therapy within 2 weeks; Five therapists within the half-life of biological agents. ⑥ Patients who are known to be allergic to drugs and materials used in this study and those who are allergic to related pharmaceutical ingredients. ⑦ Patients with psoriasis lesions abscesses ulceration infection chilblain and scars on the local skin of auricular points. ⑧ Those who are participating in clinical trials of other drugs or have participated in other clinical trials within 4 weeks. ⑨Patients that researchers think are not suitable for inclusion.

研究实施时间：

Study execute time：

从From 2024-10-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-10-01

至To      2025-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

假耳穴联合中药口服

干预措施代码：

Intervention：

Auricular point therapy with no therapeutic effect+oral traditional Chinese medicine granules（Guben Qushi Huayu formula）

Intervention code：

组别：

试验组

样本量：

20

Group：

Experimental group

Sample size：

干预措施：

耳穴压丸联合中药口服

干预措施代码：

Intervention：

Auricular point pressing seeds + oral traditional Chinese medicine granules（Guben Qushi Huayu formula）

Intervention code：

样本总量 Total sample size ： 40

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广东省中医院

单位级别：

三级甲等

Institution/hospital：

Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College Guangzhou University of Traditional Chinese Medicine)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

睡眠日记

指标类型：

次要指标

Outcome：

Sleep diary

Type：

Secondary indicator

测量时间点：

患者每日记录

测量方法：

由患者填写表格

Measure time point of outcome：

Recorded by patients every day

Measure method：

Fill in the form by the subjects

指标中文名：

BSA

指标类型：

次要指标

Outcome：

Body Surface Area (BSA)

Type：

Secondary indicator

测量时间点：

于基线、治疗过程每2周记录一次，病情加重随时访视、记录。

测量方法：

由研究者进行评分

Measure time point of outcome：

Assessments were recorded at baseline and every 2 weeks during the treatment process, with additional visits and records made whenever the condition worsened.

Measure method：

Graded by investigators

指标中文名：

DLQI

指标类型：

次要指标

Outcome：

Dermatology Life Quality Index (DLQI)

Type：

Secondary indicator

测量时间点：

于基线、治疗第8周进行评估。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were conducted at baseline and at the 8th week of treatment.

Measure method：

Calculated by the scale filled in by the subjects

指标中文名：

SAS

指标类型：

次要指标

Outcome：

Self-rating anxiety scale(SAS)

Type：

Secondary indicator

测量时间点：

于基线、治疗第8周进行评估。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were conducted at baseline and at the 8th week of treatment.

Measure method：

Calculated by the scale filled in by the subjects

指标中文名：

PASI

指标类型：

次要指标

Outcome：

Psoriasis area and severity index(PASI)

Type：

Secondary indicator

测量时间点：

于基线、治疗过程每2周记录一次，病情加重随时访视、记录。

测量方法：

由研究者进行评分

Measure time point of outcome：

Assessments were recorded at baseline and every 2 weeks during the treatment process, with additional visits and records made whenever the condition worsened.

Measure method：

Graded by investigators

指标中文名：

PSQI

指标类型：

主要指标

Outcome：

Pittsburgh sleep quality index（PSQI）

Type：

Primary indicator

测量时间点：

于基线、治疗第4、8周进行评估。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were conducted at baseline, and at the 4th and 8th weeks of treatment.

Measure method：

Calculated by the scale filled in by the subjects

指标中文名：

ISI

指标类型：

次要指标

Outcome：

Insomnia Severity Index(ISI)

Type：

Secondary indicator

测量时间点：

于基线、治疗期每2周记录一次。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were recorded at baseline and every 2 weeks during the treatment period.

Measure method：

Calculated by the scale filled in by the subjects

指标中文名：

SDS

指标类型：

次要指标

Outcome：

Self-rating depression scale(SDS)

Type：

Secondary indicator

测量时间点：

于基线、治疗第8周进行评估。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were conducted at baseline and at the 8th week of treatment.

Measure method：

Calculated by the scale filled in by the subjects

指标中文名：

PGA

指标类型：

次要指标

Outcome：

Physician Global Assessment (PGA)

Type：

Secondary indicator

测量时间点：

于基线、治疗过程每2周记录一次，病情加重随时访视、记录。

测量方法：

由研究者进行评分

Measure time point of outcome：

Assessments were recorded at baseline and every 2 weeks during the treatment process, with additional visits and records made whenever the condition worsened.

Measure method：

Graded by investigators

指标中文名：

VAS

指标类型：

次要指标

Outcome：

Itch visual analogue scale (VAS)

Type：

Secondary indicator

测量时间点：

于基线、治疗过程每2周记录一次，病情加重随时访视、记录。

测量方法：

通过患者填写的量表测量

Measure time point of outcome：

Assessments were recorded at baseline and every 2 weeks during the treatment process, with additional visits and records made whenever the condition worsened.

Measure method：

Calculated by the scale filled in by the subjects

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粪便

组织：

Sample Name：

Feces specimen

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 specimen

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：

Blood specimen

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 岁
Min age years
最大 75 岁
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）：

分层随机分配操作由广东省中医院临床研究方法学重点研究室人员采用SAS 9.2软件完成程序编写和随机化的操作。

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

Guangdong Provincial Hospital of Chinese Medicine

盲法：

单盲（对受试者、其他研究者隐藏分组，仅耳穴治疗师知晓分组）

Blinding：

Single blind (For subjects and other researchers the grouping is hidden and only the auricular point therapy operator knows the grouping.)

是否共享原始数据：

IPD sharing：

否

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）：

不适用。

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

Not applicable.

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：

数据采集使用CRF表。数据管理时应用Epidata 3.1将CRF表中的研究指标进行统一编码建立本课题专用的数据库，由双人进行独立录入，核查修改至录入信息确认无误后锁定数据库。

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

Data will be collected by the pre-designed case report form. Epidata 3.1 will be used to code the research indexes in the CRF to establish a dataset for this project. Then research data will be entered by two independent researchers. The dataset will be locked when the research data are confirmed.

数据管理委员会：

Data Managemen Committee：

有

Yes

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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