Randomization, double-blind, placebo-controlled investigator initiated trial to evaluate the efficacy and safety of So-cheong-ryong- tang in patients with Atopic dermatitis and respiratory disorders

Wonkwang University. Iksan Korean Medicine Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年8月26日

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 7(Year) 至 65(Year)（—）
性别: All

入选标准

•1) Males and females aged 7-65 years with Scoring Atopic Dermatitis score between 15 and 49, exhibiting =3 main and =3 accessory symptoms based on the diagnostic criteria developed by Hanifin & Rajka
•2) Participants with =1 box checked for respiratory symptoms, in the questionnaire survey for respiratory disorders
•3) Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions (In the case of children, written consent is required from the children and the children’s parents)

排除标准

•1)Patients receiving treatment for severe Atopic Dermatitis (such as antihistamines, adrenocortical hormones, or Korean traditional herbal medication)
•2)Patients who have previously used oral antihistamines, steroids, antibiotics, systemic photochemotherapy, and other immune suppressants in the previous 4 weeks
•3)Patients with systemic infection or under treatment with systemic antibiotics
•4)Patients with severe dermatological disorders aside from Atopic Dermatitis, pigmentation, or large scarring of the area affected by Atopic Dermatitis
•5)Patients currently receiving interferon drug treatment (i.e., interferon -a, interferon -ß, etc.)
•6)Patients with liver diseases (i.e., liver cirrhosis or liver cancer)
•7)Patients with platelet count =100,000/mm3 due to chronic hepatitis-induced liver dysfunction
•8)Patients with kidney diseases (i.e., acute/chronic renal failure, renal syndrome, etc.)
•9)Patients with acute severe cardiovascular diseases (i.e., cardiac failure, myocardial infarction, cerebral infarction, etc.)
•10)Patients with chronic diseases (i.e., uncontrolled hypertension or diabetes, etc.), gastrointestinal disorders, hyperhidrosis, dysuria, etc.
•11)Patients receiving potassium-containing drug treatment, licorice-containing drug treatment, glycyrrhizinic acid or its salts-containing drug treatment, loop diuretics (furosemide, ethacrynic acid) or thiazides diuretics (trichloromethiazide) within 4 weeks prior to the start of the study
•12)Patients receiving ephedra or ephedrine-containing drug treatment, Monoamine oxidase(MAO) inhibitors, thyroid drug treatment, catecholamine drug treatment, or xanthine drug treatment within 4 weeks prior to the start of the study
•13)Patients with a history of antipsychotic drug use within 2 months prior to the screening examination
•14)Patients who have participated in other clinical trials within the past 4 weeks
•15)Patients with a history of hypersensitivity or allergic reaction to an ingredient of the clinical trial product or the product itself
•16)Patients with a history of drug or alcohol abuse
•17)Patients who are pregnant or breastfeeding
•18)Patients who may become pregnant and have not used appropriate contraceptives (excluding those who have undergone sterilization surgery)
•19)Screening examination revealed thyroid-stimulating hormone (TSH) in the normal range 0.1 uIU / ml or less, or 10.0 uIU / ml or higher in patients with thyroid dysfunction
•20)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including diagnostic radiology outcomes
•? Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
•? Serum Creatinine > 2.0 mg/dl

研究者

发起方

Wonkwang University. Iksan Korean Medicine Hospital

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