A randomized double-blind study of Runzaozhiyang lotion in treatment of chronic hand eczema

注册号:

Registration number:

ITMCTR2025000287

最近更新日期:

Date of Last Refreshed on:

2025-04-21

注册时间:

Date of Registration:

2025-02-16

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

润燥止痒洗剂治疗慢性手部湿疹的随机双盲研究

Public title:

A randomized double-blind study of Runzaozhiyang lotion in treatment of chronic hand eczema

注册题目简写:

English Acronym:

研究课题的正式科学名称:

润燥止痒洗剂治疗慢性手部湿疹的随机双盲研究

Scientific title:

A randomized double-blind study of Runzaozhiyang lotion in treatment of chronic hand eczema

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:

臧瑞

研究负责人:

杨佼

Applicant:

Rui ZANG

Study leader:

Jiao YANG

申请注册联系人电话:

Applicant telephone:

18761697031

研究负责人电话:

Study leader's telephone:

13301099759

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:

3109811965@qq.com

研究负责人电子邮件:

Study leader's E-mail:

179610529@qq.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:

北京市西城区北线阁5号

研究负责人通讯地址:

北京市西城区北线阁5号

Applicant address:

5th North Xian Ge Xicheng District Beijing

Study leader's address:

5th North Xian Ge Xicheng District Beijing

申请注册联系人邮政编码:

Applicant postcode:

100053

研究负责人邮政编码:

Study leader's postcode:

100053

申请人所在单位:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen Hospital China Academy Of Chinese Medical Sciences

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:

2024-262-KY

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:

中国中医科学院广安门医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Guang'anmen Hospital China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/20 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Jie QIAO

伦理委员会联系地址:

北京市西城区北线阁5号

Contact Address of the ethic committee:

5th North Xian Ge Xicheng District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

‭(010) 8001552‬

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital China Academy Of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市西城区北线阁5号

Primary sponsor's address:

5th North Xian Ge Xicheng District Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'anmen Hospital China Academy Of Chinese Medical Sciences

Address:

5th North Xian Ge Xicheng District Beijing

经费或物资来源:

北京市卫生健康委员会首都卫生发展科研专项项目

Source(s) of funding:

Capitals Funds for Health Improvement and Research:

研究疾病:

慢性手部湿疹

研究疾病代码:

Target disease:

Chronic hand eczema

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:

1、通过观察润燥止痒洗剂对慢性手部湿疹的治疗作用,客观评价润燥止痒洗剂治疗慢性手部湿疹的临床疗效及安全性。 2、通过继承和挖掘祖国医学的宝贵遗产,挖掘有效的中药外治方法,寻找治疗慢性手部湿疹有效的中药洗液方剂。

Objectives of Study:

1. To observe the therapeutic effect of the moisturizing and anti-itching wash on chronic hand eczema and objectively evaluate its clinical efficacy and safety in the treatment of chronic hand eczema. 2. To inherit and explore the valuable heritage of traditional Chinese medicine uncover effective external treatment methods with Chinese herbal medicine and identify effective Chinese herbal wash formulas for the treatment of chronic hand eczema.

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《中国手部湿疹诊疗专家共识(2021 版)》中轻中度慢性手部湿疹的诊断标准(HECSI 评分:≤27 分); 2 符合《湿疹(湿疮)中医诊疗专家共识(2021 年)》中血虚风燥型慢性湿疹的诊断标准; 3 年龄 18 至 70 岁(包括 18 和 70 岁)的患者,男女均可; 4 主要受累部位为双手; 5 知情同意,并签署知情同意书,能坚持治疗者。

Inclusion criteria

1. Meets the diagnostic criteria for mild to moderate chronic hand eczema in the "Chinese Expert Consensus on the Diagnosis and Treatment of Hand Eczema (2021 Edition)" (HECSI score: ≤27). 2. Meets the diagnostic criteria for blood deficiency and wind-dry type chronic eczema in the "Expert Consensus on the Diagnosis and Treatment of Eczema" in Traditional Chinese Medicine (2021)". 3. Patients aged 18 to 70 years (inclusive) both male and female. 4. The primary affected area is both hands. 5. Informed consent has been obtained, and the patient is willing to adhere to the treatment.

排除标准:

1 患有任何可能影响实验结果评价的全身性或活动性的其他皮肤疾病(如银屑病)等,或在患处有瘢痕、纹身、胎记或其他色素性皮肤病等会影响对皮肤病变的评价的患者; 2 用药部位并发明确的细菌、病毒或真菌感染,需要抗感染治疗的患者; 3 合并了心、脑血管、肝、肾或造血系统等严重的原发性疾病的患者,以及患有精神疾病的患者; 4 治疗前30天内系统应用过糖皮质激素、免疫抑制剂的患者;90天内应用生物制剂和小分子药物治疗的患者;1周内外用过糖皮质激素、维甲酸类药物的患者; 5 对试验药物中任何成分有过敏病史的患者; 6 妊娠或哺乳期妇女,三个月内有生育计划者; 7 近3个月参加其他药物临床试验者。

Exclusion criteria:

1. Patients with any systemic or active skin diseases (such as psoriasis) that may affect the evaluation of experimental results or with scars, tattoos, birthmarks, or other pigmented skin conditions at the affected site that could interfere with the assessment of skin lesions. 2. Patients with confirmed bacterial, viral, or fungal infections at the application site who require anti-infection treatment. 3. Patients with serious underlying diseases such as cardiovascular, cerebrovascular, liver, kidney, or hematologic system disorders, as well as those with mental disorders. 4. Patients who have used systemic corticosteroids or immunosuppressants within 30 days before treatment; patients who have received biologics or small-molecule drug treatments within 90 days; patients who have used topical corticosteroids or retinoid drugs within the past week. 5. Patients with a history of allergies to any components of the trial medication. 6. Pregnant or breastfeeding women or women who plan to conceive within the next three months. 7. Patients who have participated in other clinical drug trials in the past 3 months.

研究实施时间:

Study execute time:

From 2024-01-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2025-03-01

To      2026-06-30

干预措施:

Interventions:

组别:

对照组

样本量:

61

Group:

Control group

Sample size:

干预措施:

润燥止痒洗剂模拟剂(颗粒剂)+糠酸莫米松乳膏

干预措施代码:

Intervention:

Moisturizing and anti-itching wash placebo (granules) + mometasone furoate cream

Intervention code:

组别:

治疗组

样本量:

61

Group:

Treatment group

Sample size:

干预措施:

润燥止痒洗剂(颗粒剂)+模拟糠酸莫米松乳膏

干预措施代码:

Intervention:

Moisturizing and anti-itching wash (granules) + simulated mometasone furoate cream

Intervention code:

样本总量 Total sample size : 122

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

中国中医科学院广安门医院

单位级别:

三甲

Institution/hospital:

Guang'anmen Hospital China Academy Of Chinese Medical Sciences

Level of the institution:

Tertiary Grade-A Hospital

测量指标:

Outcomes:

指标中文名:

湿疹患者自我评价POEM评分

指标类型:

次要指标

Outcome:

Patient Eczema Self-Assessment Score(POEM Score)

Type:

Secondary indicator

测量时间点:

第0天、14天、28天

测量方法:

POEM评分量表由7个问题组成,每个问题的答案反映了湿疹症状的严重程度,每个问题的答案根据频率或严重程度进行评分(0至4分)。评分总和即为 POEM 评分,总分范围为0至28分,得分越高表示湿疹的症状越严重,影响患者的生活质量越大。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

The POEM scoring scale consists of 7 questions, each reflecting the severity of eczema symptoms. The answers to each question are scored based on frequency or severity (from 0 to 4 points). The total score is the sum of the points, with a range from 0 to 28. The higher the score, the more severe the eczema symptoms and the greater the impact on the patient's quality of life.

指标中文名:

皮肤病生活质量DLQI评分

指标类型:

次要指标

Outcome:

Dermatology Life Quality Index (DLQI) Score

Type:

Secondary indicator

测量时间点:

第0天、14天、28天

测量方法:

DLQI是评估皮肤病患者生活质量的一个工具,涵盖了与皮肤病相关的症状和日常生活的影响。该量表由10个问题组成,涉及皮肤病对患者生活的各个方面,如情绪、工作、社交活动等。每个问题的评分范围是0至3,分数越高表示皮肤病对生活质量的影响越大。最终得分是所有问题得分的总和,得分越高,患者生活质量受损的程度越严重。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

DLQI is a tool used to assess the quality of life of patients with dermatological conditions, covering the symptoms related to the skin condition and its impact on daily life. The scale consists of 10 questions that address various aspects of life affected by the skin condition, such as emotions, work, and social activities. Each question is scored from 0 to 3, with higher scores indicating a greater impact of the skin condition on quality of lif

指标中文名:

皮疹面积

指标类型:

次要指标

Outcome:

Rash area

Type:

Secondary indicator

测量时间点:

第0天、14天、28天

测量方法:

本次实验仅观察手部皮损,故选择单个较典型的皮损为靶皮损,分别于治疗前和实验结束后测量其面积,按测量得出的面积大小,计算缩小的百分数作为比较。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

This experiment only observed hand lesions, so a single, typical lesion was selected as the target lesion. The area of the lesion was measured before treatment and after the experiment ended. Based on the measured area, the percentage of reduction was calculated for comparison.

指标中文名:

研究者整体评分IGA评分

指标类型:

次要指标

Outcome:

IGA score

Type:

Secondary indicator

测量时间点:

第0天、14天、28天

测量方法:

IGA评分是一种由研究者或临床医生基于患者的皮肤状况进行评估的方法。它通常用于湿疹或其他皮肤病的临床试验中,评估疾病的严重程度。IGA评分通过观察皮肤病的表现(如红肿、渗出、厚度等)来进行评分。评分通常为五分制。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

IGA Score is an assessment method used by researchers or clinicians based on the patient's skin condition. It is commonly used in clinical trials for eczema or other skin diseases to assess the severity of the disease. The IGA score is determined by observing the presentation of the skin disease (such as redness, exudation, thickness, etc.). The scoring is typically a 5-point scale.

指标中文名:

瘙痒严重程度评分

指标类型:

主要指标

Outcome:

NRS score

Type:

Primary indicator

测量时间点:

第0天、14天、28天

测量方法:

NRS 由一条类似于视觉模拟量表(visual analogue scale,VAS) 线段的水平线段组成,通常也以“没有瘙痒”和“极度瘙痒”或“所经 历过的最剧烈的瘙痒”作为起始点与终点的锚定语,并分别以“0”和 “10” 标记, 0 分代表无瘙痒, 10 分代表能想象到的最严重的瘙痒, 得分越高, 瘙痒程度越重。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

The NRS consists of a horizontal line segment similar to a visual analogue scale (VAS), typically anchored with phrases like "no itching" and "extreme itching" or "the most severe itching ever experienced" at the start and end points, respectively, and marked as "0" and "10". A score of 0 represents no itching, and a score of 10 represents the most intense itching imaginable. The higher the score, the greater the severity of the itch.

指标中文名:

手部湿疹严重指数(HECSI)评分

指标类型:

主要指标

Outcome:

HECSI score

Type:

Primary indicator

测量时间点:

第0天、14天、28天

测量方法:

将每只手分为指尖、手指(指尖以外)、手掌、手背及腕部,无皮损改变、轻度、中度、重度分别记0、1、2、3分。皮损包括红斑、丘疹、水疱、皲裂、鳞屑、水肿,每个部位总分为各皮损评分之和。

Measure time point of outcome:

Day 0, Day 14, Day 28

Measure method:

Each hand is divided into the following areas: fingertip, fingers (excluding fingertips), palm, dorsum of the hand, and wrist. For each area, the severity of lesions is scored as 0 (no change), 1 (mild), 2 (moderate), or 3 (severe). Lesions include erythema, papules, vesicles, fissures, scales, and edema. The total score for each area is the sum of the scores for each type of lesion.

采集人体标本:

Collecting sample(s)
from participants:

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

分别在第0天和第28天留取

Fate of sample 

Destruction after use

Note:

Retain on day 0 and day 28 respectively

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

分别在第0天和第28天留取

Fate of sample 

Destruction after use

Note:

Retain on day 0 and day 28 respectively

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 70
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):

由独立的第三方采用计算机编盲 a.统一编号:将纳入病例采用随机数字表,随机分为A、B两组,每组61例。首先将总体中的所有研究对象进行统一编号,001~122,充分混合,使各样本编号均匀分布,符合“机会均等 的原则。 b. 确定行名:在表上任选一行数字,由该行数字决定起点行的数。如选择25行,即从上往下第25行为起点行。若选择的数大于50,则用该数减去50,将所得余数为起点行。若选择0或00行,则以第50行为起点行。 c.确定列名:列名的确定方法与行名的确定方法相同。 d.录取号码:行名和列名决定后,以起始行数和起始列数的交叉点处的数为起始点,按一定顺序方向(如自左向右或自右向左,从上往下或由下而上)进行依次录取号码,遇到大于总体的号码或重复的号码,舍去不要,直至录取到所抽取的样本数满额为止。

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

Randomization by an independent third party using computer blinding: a. Uniform numbering: The cases included in the study are randomly assigned to Group A and Group B with 61 cases in each group using a random number table. All research subjects in the population are first assigned uniform numbers from 001 to 122, and these numbers are well mixed to ensure that the sample numbers are evenly distributed in accordance with the principle of "equal opportunity." b. Determining row names: A random row of numbers is selected from the table to determine the starting row number. For example, if the 25th row is chosen, it becomes the starting row. If the selected number is greater than 50, subtract 50 from it, and the remainder will be the starting row. If the selected row is 0 or 00, the 50th row will be used as the starting row. c. Determining column names: The method for determining the column name is the same as for the row name. d. Assigning case numbers: After determining the row and column namenames, case number is assigned based on the intersection point of the starting row and column. Numbers are then recorded sequentially in a set direction (e.g. left to right right to left top to bottom or bottom to top). If a number greater than the total number of cases or a duplicate number is encoencountered,is discarded. This process continues until the required number of sample cases is reached.

盲法:

Blinding:

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):

no

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

no

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:临床研究数据记录在研究病例和病例记录表(Case Record Form, CRF)中。 数据管理:原始研究文件保存在临床观察单位,病例报告表数据在研究过程中保存在临床观察单位,同时以电子数据形式及时提交给指定的数据管理中心,试验结束后纸质病例报告表需要同时保存在临床研究负责单位,以便随时备查。原始研究数据保存的期限为5年。临床研究的数据记录通过网络定期打包上报到临床研究数据管理中心进行管理,在数据上报过程中发现问题须及时纠正,以减轻后期数据核查的工作量。采用双录方式及时进行数据录入,并进行数据跟踪报告。

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

**Data Collection**: Clinical research data is recorded in the study case files and Case Record Forms (CRFs). **Data Management**: Original research documents are stored at the clinical observation site and data from case report forms are kept at the clinical observation site during the study. At the same time electronic data is promptly submitted to the designated data management center. After the trial ends the paper case report forms need to be kept at the clinical research responsible unit for future reference. The retention period for the original research data is 5 years. Clinical research data is regularly packaged and reported to the clinical research data management center for management via the network. Any issues identified during the reporting process must be corrected promptly to reduce the workload for subsequent data verification. A double-entry method is used for timely data entry and data tracking reports are conducted.

数据管理委员会:

Data Managemen Committee:

No

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above