KCT0003713招募中未知
Efficacy and Safety of Soshiho-tang in patients with Atopic dermatitis and Gastrointestinal disorders: a double-blind, randomized, placebo-controlled clinical trial
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:
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
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
- 3(Year) 至 18(Year)（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •Participating patients should meet all of the following inclusion criteria:
- •1.Males and females aged 3-18 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 gastrointestinal symptoms or food allergy history, in the questionnaire survey for gastrointestinal disorders
- •3.Participants who have fully understood information provided about the study, voluntarily decided to participate, and agreed to comply with precautions (written consent is required from the participants’ parents)
排除标准
- •Exclusion criteria
- •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 a history of antipsychotic drug use within 2 months prior to the screening examination
- •11.Patients who have participated in other clinical trials within the past 4 weeks
- •12.Patients with a history of hypersensitivity or allergic reaction to an ingredient of the clinical trial product or the product itself
- •13.Patients with a history of drug or alcohol abuse
- •14.Patients who are pregnant or breastfeeding
- •15.Patients who may become pregnant and have not used appropriate contraceptives (excluding those who have undergone sterilization surgery)
- •16.Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including diagnostic radiology outcomes
研究者
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