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Clinical Evaluation of ZiyinChushi Decoction in the Treatment of Atopic Dermatitis with Yin Deficiency and Dampness Accumulation Syndrome

注册号：

Registration number：

ITMCTR2022000042

最近更新日期：

Date of Last Refreshed on：

2022-07-29

注册时间：

Date of Registration：

2022-06-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

滋阴除湿汤治疗阴虚湿恋证特应性皮炎临床疗效评价

Public title：

Clinical Evaluation of ZiyinChushi Decoction in the Treatment of Atopic Dermatitis with Yin Deficiency and Dampness Accumulation Syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

滋阴除湿汤治疗阴虚湿恋证特应性皮炎临床疗效评价

Scientific title：

Clinical Evaluation of ZiyinChushi Decoction in the Treatment of Atopic Dermatitis with Yin Deficiency and Dampness Accumulation Syndrome

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：

CI2021A02302

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：

ChiCTR2200062185 ; ChiMCTR2200006386

申请注册联系人：

万祖霖

研究负责人：

沈冬

Applicant：

WAN Zu-lin

Study leader：

SHEN Dong

申请注册联系人电话：

Applicant telephone：

18810236016

研究负责人电话：

Study leader's telephone：

13661395388

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：

853826510@qq.com

研究负责人电子邮件：

Study leader's E-mail：

Shendong2011@sina.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：

北京市西城区中国中医科学院广安门医院

研究负责人通讯地址：

北京市西城区中国中医科学院广安门医院

Applicant address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China

Study leader's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China

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：

2022-122-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伦理委员会

Name of the ethic committee：

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

伦理委员会批准日期：

Date of approved by ethic committee：

2022/6/24 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

QIAO Jie

伦理委员会联系地址：

北京市西城区中国中医科学院广安门医院4号楼452室

Contact Address of the ethic committee：

Room 452, Floor 4, Building No.4, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-88001552

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：

北京市西城区中国中医科学院广安门医院

Primary sponsor's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, 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)：

北京市

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

具体地址：

北京市西城区中国中医科学院广安门医院

Institution
hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China

经费或物资来源：

中国中医科学院科技创新工程项目

Source(s) of funding：

Science and Technology Innovation Project of China Academy of Chinese Medical Sciences

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：

1、客观评价滋阴除湿汤的临床疗效及安全性，为滋阴除湿汤的推广、应用提供高质量循证证据。 2、发挥中医疗效优势，进一步继承传扬朱老的学术思想，拓展滋阴除湿汤的适用范围。

Objectives of Study：

1. Objectively evaluate the clinical efficacy and safety of Ziyinchushi Decoction, and provide high-quality evidence-based evidence for the promotion and application of Ziyinchushi Decoction. 2. Give full play to the advantages of traditional Chinese medicine, further inherit and spread the academic thought of Professor ZHU Ren-kang, and expand the scope of application of Ziyinchushi Decoction.

药物成份或治疗方案详述：

治疗组：将滋阴除湿汤配方颗粒倒入容器，加入适量热开水，搅拌混匀，温服，每日2次。 全身涂抹适量硅霜，每日2次。 对照组：将模拟剂配方颗粒倒入容器，加入适量热开水，搅拌混匀，温服，每日2次。 全身涂抹适量硅霜，每日2次。 疗程：总共治疗4周，每2周复诊1次。中途痊愈者可停止用药，纳入疗效统计。 处方优化与质量控制：由江阴天江药业有限公司负责制备，按我院提供处方在GMP条件下组织生产，采用中药配方颗粒混合包装的生产工艺及质量标准；并对药品生产质量负责及提供质量检验报告单。 治疗组药物与安慰剂成分：治疗组药物制备：药物成分包括生地黄、玄参、当归、丹参、茯苓、泽泻、白鲜皮、蛇床子。 安慰剂制备：由江阴天江药业有限公司负责制备，外观、重量、气味、色泽与滋阴除湿汤近似，不含药物。 硅霜准备：选用精心?硅霜（北京协和精细化学制品有限公司，京妆20160004号）。主要成分：水、聚二甲基硅氧烷、甘油、矿油、硬脂酸、硬脂醇、鲸蜡醇、山里醇聚醚-20蜂蜡、椰油酰胺DEA、羟苯乙酯。净含量：100g/支。

Description for medicine or protocol of treatment in detail：

Treatment group: Pour the formula granules of nourishing yin and dehumidifying soup into a container, add an appropriate amount of hot water, stir and mix well, and take it warm, 2 times a day. Apply an appropriate amount of silicone cream all over the body, 2 times a day. Control group: Pour the simulant formula granules into a container, add an appropriate amount of hot water, stir and mix well, and take it warm, twice a day. Apply an appropriate amount of silicone cream all over the body, 2 times a day. Course of treatment: A total of 4 weeks of treatment, with a follow-up visit every 2 weeks. Those who recovered in the middle can stop taking the medicine and be included in the curative effect statistics. Preparation of decoction-free granules for nourishing yin and dehumidifying soup: Ziyinchushi Decoction is the experience formula of Professor ZHU Ren-kang, a famous skin surgery expert in our country. It has a good effect in clinical treatment of eczema and dermatitis. The distributed papules or dry patches are accompanied by a little exudation, accompanied by a red or pale tongue, little or clean fur, or slightly greasy roots. The main components of the current nourishing yin and dampness decoction are: Rehmannia glutinosa, Scrophulariaceae, Angelica sinensis, Salvia miltiorrhiza, Poria, Alisma, white fresh skin, and Cnidium. Prescription optimization and quality control: Jiangyin Tianjiang Pharmaceutical Co., Ltd. is responsible for the preparation, and organizes production according to the prescription provided by our hospital under GMP conditions, adopts the production process and quality standards of traditional Chinese medicine formula granules mixed packaging; is responsible for the quality of drug production and provides quality inspection reports. Treatment group drug and placebo components: Preparation of medicine for the treatment group: The medicine ingredients include Rehmannia glutinosa, Scrophulariaceae, Angelica sinensis, Salvia miltiorrhiza, Poria cocos, Alisma orientalis, fresh white skin, and Cnidium. Placebo preparation: It is prepared by Jiangyin Tianjiang Pharmaceutical Co., Ltd. The appearance, weight, smell, color and luster are similar to those of Nourishing Yin and Dehumidifying Decoction, without drugs. Choose Jingxin? Silicon Cream (Beijing Xiehe Fine Chemicals Co., Ltd., Beijing Cosmetic No.20160004). Main Ingredients: Water, Dimethicone, Glycerin, Mineral Oil, Stearic Acid, Stearyl Alcohol, Cetyl Alcohol, Beheneth-20 Beeswax, Cocamide DEA, Ethyl Paraben. Net content: 100g/piece.

纳入标准：

1 符合《中国特应性皮炎诊疗指南》，张建中等提出的中国AD诊断标准； 2 年龄18至70岁（包括18和70岁）； 3 SCORAD评分为25至50分（包括25和50分）； 4 符合中医“阴虚湿恋证”诊断标准； 5 签署知情同意书。

Inclusion criteria

1 Meet the Chinese AD diagnostic criteria proposed by ZHANG Jian-zhong in the "Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis"; 2 Age 18 to 70 (including 18 and 70); 3 SCORAD score of 25 to 50 (including 25 and 50); 4 Meet the diagnostic criteria of "Yin Deficiency and Damp Love Syndrome" in traditional Chinese medicine; 5 Sign the informed consent.

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（如急性过敏性皮炎、银屑病、红斑狼疮）的患者；或在皮损部位有瘢痕、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 合并心、脑血管、肝、肾、胃肠道、造血系统、内分泌等严重的原发性疾病的患者，以及患有精神疾病的患者； 3 妊娠、哺乳期妇女及近3个月准备怀孕者； 4 治疗前28天内应用过生物制剂；治疗前14天内系统使用过抗组胺药、糖皮质激素、免疫抑制剂等治疗药物的患者；或治疗前7天内外用糖皮质激素、钙调神经磷酸酶抑制剂等治疗药物的患者； 5 试验观察期间正在参加其他临床试验者； 6 对本研究药物过敏者。

Exclusion criteria：

1 Patients with any other systemic or active skin diseases (such as acute allergic dermatitis, psoriasis, lupus erythematosus) that may affect the evaluation of the test results; or have scars, tattoos, birthmarks or other pigments at the skin lesions Patients with sexual dermatosis, etc., which can affect the evaluation of skin lesions; 2. Patients with serious primary diseases such as heart, cerebrovascular, liver, kidney, gastrointestinal tract, hematopoietic system, endocrine, etc., as well as patients with mental diseases; 3. Pregnant, lactating women and those who are about to become pregnant in the past 3 months; 4. Patients who have used biological agents within 28 days before treatment; patients who have systematically used antihistamines, glucocorticoids, immunosuppressants and other therapeutic drugs within 14 days before treatment; or topical glucocorticoids and calcineurin within 7 days before treatment Patients with therapeutic drugs such as inhibitors; 5 Those who are participating in other clinical trials during the trial observation period; 6 Those who are allergic to the drug in this study.

研究实施时间：

Study execute time：

从From 2022-07-25

至To      2024-10-31

征募观察对象时间：

Recruiting time：

从From 2022-07-25

至To      2024-03-31

干预措施：

Interventions：

组别：

治疗组

样本量：

32

Group：

Treatment Group

Sample size：

干预措施：

治疗组：将滋阴除湿汤配方颗粒倒入容器，加入适量热开水，搅拌混匀，温服，每日2次。全身涂抹适量硅霜，每日2次。

干预措施代码：

A

Intervention：

Pour the formula granules of nourishing yin and dehumidifying soup into a container, add an appropriate amount of hot water, stir and mix well, and take it warm, 2 times a day. Apply an appropriate amount of silicone cream all over the body, 2 times a day.

Intervention code：

组别：

对照组

样本量：

32

Group：

Control Group

Sample size：

干预措施：

对照组：将模拟剂配方颗粒倒入容器，加入适量热开水，搅拌混匀，温服，每日2次。全身涂抹适量硅霜，每日2次。

干预措施代码：

B

Intervention：

Control group: Pour the simulant formula granules into a container, add an appropriate amount of hot water, stir and mix well, and take it warm, twice a day. Apply an appropriate amount of silicone cream all over the body, 2 times a day.

Intervention code：

样本总量 Total sample size ： 64

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

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 Hospital

测量指标：

Outcomes：

指标中文名：

中医症状/体征记录

指标类型：

次要指标

Outcome：

TCM symptom/sign record

Type：

Secondary indicator

测量时间点：

第0，14±3，28±3天

测量方法：

Measure time point of outcome：

0, 14±3, 28±3 days

Measure method：

指标中文名：

皮肤病生活质量指数量表（DLQI）

指标类型：

次要指标

Outcome：

Dermatology Life Quality Index (DLQI）

Type：

Secondary indicator

测量时间点：

第0，14±3，28±3天

测量方法：

Measure time point of outcome：

0, 14±3, 28±3 days

Measure method：

指标中文名：

特应性皮炎评分（SCORAD）

指标类型：

主要指标

Outcome：

Scoring Atopic Dermatitis Index (SCORAD)

Type：

Primary indicator

测量时间点：

第0，14±3，28±3天

测量方法：

Measure time point of outcome：

0, 14±3, 28±3 days

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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）：

随机化：借助SAS统计软件PROC PLAN过程语句，给定种子数，确定段长。产生64例受试者所接受处理(试验组和对照组)的随机安排，即列出流水号为01-64所对应的治疗分配(即随机编码表)。

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

Randomization: With the help of the SAS statistical software PROC PLAN procedure statement, the number of seeds is given, and the segment length is determined. Generate a random arrangement of the treatments (experimental group and control group) received by 64 subjects, that is, list the treatment assignments

盲法：

双盲安慰剂对照（受试者、评价者盲）。

Blinding：

Double-blind placebo-controlled (subject, rater blinded).

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）：

无

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：

采用病例报告表（CRF）记录研究数据，并及时录入系统。临床研究将根据风险大小制定相应的数据安全监察计划。所有不良事件均详细记录，恰当处理并追踪直到妥善解决或病情稳定，按照规定及时向广安门医院伦理委员会、主管部门和药品监督管理部门报告严重不良事件与非预期事件等；主要研究者定期对所有不良事件进行累积性回顾，必要时召开研究者会议评估研究的风险与受益。

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

Study data were recorded using a case report form (CRF) and entered into the system in a timely manner. Clinical research will formulate a corresponding data safety monitoring plan according to the size of the risk. All adverse events are recorded in detail, properly handled and tracked until they are properly resolved or the condition is stable. Serious adverse events and unexpected events are reported to the Ethics Committee, competent department and drug supervision and management department of Guang'anmen Hospital in a timely manner in accordance with regulations; the principal investigator regularly All adverse events were reviewed cumulatively, and investigator meetings were held as necessary to assess the risks and benefits of the study.

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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