KCT0006784招募中未知
Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis: a protocol for a randomized, usual care-controlled, assessor-blinded, parallel, pilot clinical trial
Daejeon Korean Medicine Hospital of Daejeon University0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- 19?(Year) 至 65?(Year)（—）
- 性别
- All
入选标准
- •(1) adults aged 19-65 years at the screening visit
- •(2) the intensity of anorexia measured by 0-100mm visual analogue scale is 40 points or more
- •(3) diagnosis of atopic dermatitis based on the Hanifin and Rajka diagnostic criteria
- •(4) mild to moderate atopic dermatitis diagnosed by the SCORing of Atopic Dermatitis score (score 15–50).
- •(5) those who have voluntarily signed written informed consent approved by the institutional review board, after sufficient explanation of this study
排除标准
- •(1) those who have an organic disease that can cause anorexia or have alarm symptoms such as rapid weight loss of 10% or more within the last 6 months
- •(2) those who have received an appetite stimulant, health functional food (other than lactic acid bacteria) and Korean medicine treatment for the purpose of improving anorexia within 2 weeks prior to screening
- •(3) those with severe skin diseases other than atopic dermatitis
- •(4) those who have received oral steroids, oral antibiotics, systemic immunosuppressants, or systemic photochemotherapy within 4 weeks prior to screening, those who have used antihistamines, topical steroids, topical immunomodulators and topical antibiotics within 1 week prior to screening, and those who received health functional food (excluding lactic acid bacteria) and Korean medicine treatment for the purpose of improving atopic dermatitis within 2 weeks prior to screening
- •(5) those who started administering lactic acid bacteria within 2 weeks prior to screening
- •(6) participants with serious medical conditions to participate in this clinical trial
- •6-1. those who have been diagnosed with a mental illness such as anorexia nervosa, depression, or anxiety disorder
- •6-2. uncontrolled hypertension (in case of systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher at screening)
- •6-3. uncontrolled diabetes (in case of HbA1c of 9% or higher or fasting blood glucose of 160 mg/dl or higher at screening)
- •6-4. severe liver or renal disease (aspartate aminotransferase or alanine aminotransferase levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal)
- •6-5. past or present malignancy
- •6-6. serious uncontrolled systemic diseases including cardiovascular, respiratory, digestive, genitourinary, nervous/psychiatric and blood diseases, or serious infectious diseases
- •(7) participants with a history of alcohol abuse or drug abuse within the past year
- •(8) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •(9) participants with known hypersensitivity to investigational products
- •(10) participants who had taken other investigational products within 4 weeks
- •(11) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
- •(12) participants who are judged to be inappropriate for participating this study
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