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祛湿止痒方治疗湿热浸淫型肛周湿疹的临床观察

注册号：

Registration number：

ITMCTR2025001139

最近更新日期：

Date of Last Refreshed on：

2025-06-09

注册时间：

Date of Registration：

2025-06-09

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

祛湿止痒方治疗湿热浸淫型肛周湿疹的临床观察

Public title：

Progress of Chinese and Western medicine in the treatment of perianal eczema

注册题目简写：

祛湿止痒方治疗湿热浸淫型肛周湿疹的临床观察

English Acronym：

Progress of Chinese and Western medicine in the treatment of perianal eczema

研究课题的正式科学名称：

祛湿止痒方治疗湿热浸淫型肛周湿疹的临床观察

Scientific title：

Progress of Chinese and Western medicine in the treatment of perianal eczema

研究课题的正式科学名称简写：

祛湿止痒方治疗湿热浸淫型肛周湿疹的临床观察

Scientific title acronym：

Progress of Chinese and Western medicine in the treatment of perianal eczema

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：

孙元亮

研究负责人：

孙元亮

Applicant：

YuanLiang Sun

Study leader：

YuanLiang Sun

申请注册联系人电话：

Applicant telephone：

15389877191

研究负责人电话：

Study leader's telephone：

15389877191

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：

1571288301@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1571288301@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：

陕西省咸阳市

研究负责人通讯地址：

陕西省咸阳市

Applicant address：

Xianyang Shaanxi

Study leader's address：

Xianyang Shaanxi

申请注册联系人邮政编码：

Applicant postcode：

712046

研究负责人邮政编码：

Study leader's postcode：

712046

申请人所在单位：

陕西中医药大学

Applicant's institution：

Shaanxi 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：

2025AKZYLL-KY005-01

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：

安康市中医医院涉及人的生物医学研究伦理分会

Name of the ethic committee：

Ankang Hospital of Traditional Chinese Medicine Ethics Sub-Committee on Biomedical Research Involving Human Beings

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/13 0:00:00

伦理委员会联系人：

李天怡

Contact Name of the ethic committee：

TianYi Li

伦理委员会联系地址：

陕西省安康市汉滨区巴山东路47号

Contact Address of the ethic committee：

No. 47 Bashan East Road Hanbin District Ankang City Shaanxi Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0915-8183569

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2009akzykjk@163.com

研究实施负责（组长）单位：

安康市中医医院肛肠科

Primary sponsor：

Ankang Hospital of Traditional Chinese Medicine Department of Anus and Intestines

研究实施负责（组长）单位地址：

安康市中医医院内科楼西附楼3层

Primary sponsor's address：

3F West Annex Internal Medicine Building Ankang Traditional Chinese Medicine Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

安康市

Country：

China

Province：

Shaanxi Province

City：

Ankang prefecture level city

单位(医院)：

安康市中医医院

具体地址：

陕西省安康市汉滨区巴山东路47号

Institution
hospital：

Ankang Traditional Chinese Medicine Hospital

Address：

No. 47 Bashan East Road Hanbin District Ankang City Shaanxi Province China

经费或物资来源：

本研究项目无经费或物资支持，主要来源于患者就诊后的所产生的诊疗费。即由患者自筹。

Source(s) of funding：

This research project is funded or supported by no financial or material resources mainly derived from the medical expenses incurred after patients seek treatment.That is the patient should raise funds themselves.

研究疾病：

肛周湿疹（肛门湿疡）

研究疾病代码：

A08.03.09

Target disease：

Perianal Eczema (anal wet ulcer）

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：

通过中药干预治疗湿热浸淫型肛周湿疹，观察其临床疗效，总结经验，开展规范的临床对照试验，优化中医药治疗湿热浸淫型肛周湿疹的方案，提高诊疗水平。

Objectives of Study：

Through the intervention of traditional Chinese medicine in the treatment of damp-heat-immersed perianal eczema the clinical efficacy was observed experience was summarized and standardized clinical controlled trials were carried out to optimize the protocol of traditional Chinese medicine in the treatment of damp-heat-immersed perianal eczema and to improve the level of diagnosis and treatment.

药物成份或治疗方案详述：

治疗组：祛湿止痒方：苦参30g、连翘25g、紫草20g、苍术15g、白矾20g、滑石20g、千里光15g、百部20g、蛇床子20g、刺蒺藜（炒）15g。 对照组：地奈德乳膏（重庆华邦制药有限公司，国药准字H20060725）规格15g/盒，成分：地奈德。 用药方法、疗程：a.治疗组：每次取200ml的祛湿止痒方汤剂，取适量可完全覆盖湿疹部位大小的无菌纱布浸于药液中，用温水洗净患处后，研究参与者呈侧卧位或俯卧位，将浸泡于药液中的纱布拧至不滴水后湿敷于患处，每5min更换一次纱布，始终让纱布保持湿润状态，每次 15min，结束后用无菌纱布覆盖，早晚各一次。b.对照组：研究参与者用温水洗净患处后，采取侧卧位或俯卧位，然后使用医用棉签在患处涂抹地奈德乳膏，纱布覆盖，早晚各一次。

Description for medicine or protocol of treatment in detail：

Treatment group: dispel dampness and relieve itching formula: 30g of bitter ginseng 25g of forsythia 20g of comfrey 15g of atractylodes macrocephala 20g of alum 20g of talcum 15g of chrysanthemum 20g of centella asiatica 20g of snakebeds 15g of tribulus terrestris (fried). Control group: Dinaid cream (Chongqing Huabang Pharmaceutical Co. Ltd. State Drug License H20060725) specification 15g/box ingredients: Dinaid. Medication method course of treatment: a. Treatment group: each time to take 200 ml of expectorant dampness and relieving itching formula soup take the appropriate amount can completely cover the size of eczema parts of the sterile gauze immersed in the liquid with warm water to wash the affected area the study participant was in the lateral position or prone position will be immersed in the liquid in the gauze twisted to the non-dripping wet compresses on the affected area every 5min replacement of the gauze always allow the gauze to maintain a wet state every time! 15min covered with sterile gauze at the end once in the morning and once in the evening. b. Control group: after the study participants washed the affected area with warm water they took the lateral position or prone position and then used medical swabs to apply Dinocaprolactone cream on the affected area covered with gauze once in the morning and once in the evening.

纳入标准：

①符合中医和西医的诊断标准。②18岁-70岁（包含18岁和70岁）。③身体状态较为良好。④肛门发育无畸形及肛门功能正常。⑤肛周皮肤无感染性疾病。⑥自愿签署知情同意书。

Inclusion criteria

① Meet the diagnostic criteria of TCM and Western medicine. ② 18-70 years old (including 18 and 70 years old). ③ Physical condition is relatively good. ④ No deformity in anal development and normal anal function. ⑤ No infectious disease of perianal skin. ⑥ Voluntarily sign the informed consent form.

排除标准：

①首次就诊前14天内使用过激素、抗组胺药物或是其他影响治疗和评估肛周湿疹药物。②合并有混合痔、肛痈、肛瘘、肛裂等具有手术指征的肛肠类疾病，及手术后切口未愈合。③合并有严重的心、肝、肾病，高血压、糖尿病、冠心病等疾病。④具有精神、神经功能障碍及认知功能障碍。⑤月经期、妊娠期、哺乳期或有妇科疾病（阴道炎、寄生虫感染等）。⑥对本次试验所使用的药物过敏或是过敏体质。⑦合并出现有生殖器疱疹、尖锐湿疣、淋病等传染性疾病。

Exclusion criteria：

① Have used hormone antihistamine or other drugs that affect the treatment and evaluation of perianal eczema within 14 days before the first visit. ② Combined with mixed hemorrhoids anal carbuncle anal fistula anal fissure and other anorectal diseases with surgical indications and the incision has not healed after surgery. ③ Combined with serious heart liver kidney disease hypertension diabetes coronary heart disease and other diseases. ④Have mental and neurological dysfunction and cognitive dysfunction. ⑤ During menstruation pregnancy breastfeeding or with gynecological diseases (vaginitis parasitic infections etc.). ⑥ Hypersensitivity or allergy to the drugs used in this trial. ⑦ Have a combination of infectious diseases such as genital herpes condyloma acuminatum gonorrhea or other infectious diseases.

研究实施时间：

Study execute time：

从From 2025-03-13

至To      2026-03-12

征募观察对象时间：

Recruiting time：

从From 2025-07-01

至To      2026-03-12

干预措施：

Interventions：

组别：

治疗组

样本量：

30

Group：

Treatment group

Sample size：

干预措施：

祛湿止痒方

干预措施代码：

Intervention：

Dispel dampness and relieve itching formula

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

地奈德乳膏

干预措施代码：

Intervention：

Dinaid cream

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)：

陕西省

市(区县)：

安康市

Country：

China

Province：

Shaanxi Province

City：

Ankang prefecture level city

单位(医院)：

陕西中医药大学附属安康市中医医院

单位级别：

三级甲等

Institution/hospital：

Shaanxi University of Chinese Medicine Affiliated Ankang Traditional Chinese Medicine Hospital

Level of the institution：

Level 3A

测量指标：

Outcomes：

指标中文名：

瘙痒评分

指标类型：

主要指标

Outcome：

Pruritus Score

Type：

Primary indicator

测量时间点：

在入组当日、治疗第14天及治疗结束后的第30天、第60天、第90天测量

测量方法：

根据患者的临床表现，结合疗效观察指标（症状评分）进行量化评估，分值0-3分，分4级判定

Measure time point of outcome：

Measured on the day of enrollment, on the 14th day of treatment, and on the 30th, 60th, and 90th days after the end of treatment.

Measure method：

Quantitative assessment based on the patient's clinical manifestations, combined with efficacy observation indicators (symptom scores), with a score of 0-3 and 4 levels of judgment.

指标中文名：

皮肤病生活质量评分

指标类型：

次要指标

Outcome：

Dermatology Life Quality Index

Type：

Secondary indicator

测量时间点：

在入组当日、治疗第14天及治疗结束后的第30天、第60天、第90天测量

测量方法：

根据患者的临床表现， 结合皮肤病生活质量量表，以问答的方式进行评估

Measure time point of outcome：

Measured on the day of enrollment, on the 14th day of treatment, and on the 30th, 60th, and 90th days after the end of treatment.

Measure method：

The assessment is based on the patient's clinical presentation and is based on the Dermatologic Quality of Life Scale (DQOLS), which is a question-and-answer format.

指标中文名：

肛周潮湿评分

指标类型：

次要指标

Outcome：

Perianal moisture Score

Type：

Secondary indicator

测量时间点：

在入组当日、治疗第14天及治疗结束后的第30天、第60天、第90天测量

测量方法：

根据患者的临床表现，结合疗效观察指标（症状评分）进行量化评估，分值0-3分，分4级判定

Measure time point of outcome：

Measured on the day of enrollment, on the 14th day of treatment, and on the 30th, 60th, and 90th days after the end of treatment.

Measure method：

Quantitative assessment based on the patient's clinical manifestations, combined with efficacy observation indicators (symptom scores), with a score of 0-3 and 4 levels of judgment.

指标中文名：

疗效判定

指标类型：

次要指标

Outcome：

Efficacy Evaluation

Type：

Secondary indicator

测量时间点：

在治疗结束后的第30天、第60天、第90天测量

测量方法：

以《中药新药临床研究指导原则》中的疾病疗效判定标准为主，根据前期的量化指标分别算出治疗前和治疗后的症状总积分，然后根据“尼莫地平法”公式得出有效率，分4级判定。

Measure time point of outcome：

Measured on days 30, 60, and 90 after the end of treatment.

Measure method：

Based on the criteria for determining the efficacy of the disease in the "Guiding Principles for Clinical Research of New Chinese Medicines", the total points of symptoms before and after treatment were calculated according to the quantitative indexes in the previous stage, and then the effective rate was derived according to the formula of the "Nimodipine Method", which was divided into 4 levels of judgment.

指标中文名：

皮损形态

指标类型：

次要指标

Outcome：

Patterns of skin lesions

Type：

Secondary indicator

测量时间点：

在入组当日、治疗第14天及治疗结束后的第30天、第60天、第90天测量

测量方法：

根据患者的临床表现，结合疗效观察指标（症状评分）进行量化评估，分值0-3分，分4级判定

Measure time point of outcome：

Measured on the day of enrollment, on the 14th day of treatment, and on the 30th, 60th, and 90th days after the end of treatment.

Measure method：

Quantitative assessment based on the patient's clinical manifestations, combined with efficacy observation indicators (symptom scores), with a score of 0-3 and 4 levels of judgment.

指标中文名：

复发情况

指标类型：

次要指标

Outcome：

Recurrence Status

Type：

Secondary indicator

测量时间点：

治疗14天后，针对本次试验后获得痊愈和显效的患者，在治疗结束后的1个月（第30天）、2个月（第60天）、3个月（第90天）进行电话随访，了解其身体状况及日常生活和过去有无变化，必要时嘱患者来院复查。

测量方法：

复发病例的判断标准为：治愈后肛周皮肤再次出现瘙痒、丘疹、潮湿等临床表现。根据患者的临床表现，结合疗效观察指标（症状评分）进行量化评估，分值0-3分，分4级判定

Measure time point of outcome：

After 14 days of treatment, patients who were cured and showed significant effects after this trial were followed up by telephone at 1 month (30th day), 2 months (60th day), and 3 months (90th day) after the end of the treatment, to find out whether there were any changes in their physical condition and daily life, and to ask the patients to come to the hospital for review if necessary.

Measure method：

The criteria of recurrence are: itching, pimples, wetness and other clinical manifestations of the perianal skin after cure. According to the patient's clinical manifestations, combined with the efficacy observation index (symptom score) for quantitative assessment, the score 0-3 points, divided into 4 levels of judgment.

指标中文名：

皮损面积

指标类型：

次要指标

Outcome：

Lesion area

Type：

Secondary indicator

测量时间点：

在入组当日、治疗第14天及治疗结束后的第30天、第60天、第90天测量

测量方法：

根据患者的临床表现，结合疗效观察指标（症状评分）进行量化评估，分值0-3分，分4级判定

Measure time point of outcome：

Measured on the day of enrollment, on the 14th day of treatment, and on the 30th, 60th, and 90th days after the end of treatment.

Measure method：

Quantitative assessment based on the patient's clinical manifestations, combined with efficacy observation indicators (symptom scores), with a score of 0-3 and 4 levels of judgment.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

No

Tissue：

No

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 70 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）：

由研究者根据随机数表法将研究参与者随机纳入治疗组和对照组两个组别

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

Participants were randomized into the treatment and control groups by the researcher according to the randomization table method.

盲法：

无

Blinding：

No

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）：

-

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

-

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：

通过病例记录表采集数据信息，然后将收集的信息用计算机Excel方法进行数据双人录入和管理，数据管理确保研究数据的真实性、完整性和准确性，保证临床研究数据的可溯源性。研究资料专人专柜保存至少10年，防火、防虫、防潮、防盗。电子版上传至伦理办公室和科研管理部门，同时做好容灾备份。

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

The data information was collected through the medical record sheet and then the collected information was used for data entry and management by computerized Excel method for two-person data entry and management and the data management ensured the authenticity completeness and accuracy of the study data and guaranteed the traceability of the clinical study data. The research data are kept in special cabinets for at least 10 years and are protected against fire insects moisture and theft. The electronic version is uploaded to the Ethics Office and the research management department and disaster-tolerant backup is done at the same time.

数据管理委员会：

Data Managemen Committee：

无

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):

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