Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- SCORing of Atopic Dermatitis (SCORAD) total score
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Sargassum Horneri Extract in patients with skin hypersensitivity for 12 weeks.
详细描述
Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Sargassum Horneri Extract in patients with skin hypersensitivity for 12 weeks; the safety of the compound are also evaluate. The Investigators examine SCORAD(SCORing of Atopic Dermatitis) score, PGA (Patient Global assessment) score, IGA (Investigator Global assessment) score, total IgE, eosinophil counts, ECP, IL-4, IL-31, and TARC at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 1,000 mg of Sargassum Horneri Extract or a placebo each day for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Atopy by Hanifin & Rajka diagnostic criteria
- •SCORAD < 40
排除标准
- •Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
- •Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- •History of viral hepatitis or cancer
- •Uncontrolled hypertension
- •History of serious cardiac disease such as angina or myocardial infarction
- •History of gastrectomy
- •History of medication for psychiatric disease
- •Administration of oriental medicine including herbs within the past 4 weeks
结局指标
主要结局
SCORing of Atopic Dermatitis (SCORAD) total score
时间窗: Change from Baseline SCORAD total score at 3 months
Change in SCORAD total score during 3 months
次要结局
- Patient Global assessment (PGA) score(Change from Baseline PGA score at 3 months)
- Investigator Global assessment (IGA) score(Change from Baseline IGA score at 3 months)
- Total Immunoglobulin E (IgE)(Change from Baseline total IgE (IU/mL) level at 3 months)
- Eosinophil cationic protein (ECP)(Change from Baseline ECP (μg/L) level at 3 months)
- Interleukin-31 (IL-31)(Change from Baseline IL-31 (ng/mL) level at 3 months)
- Eosinophil counts(Change from Baseline eosinophil counts (/uL) at 3 months)
- Thymus- and activation-regulated chemokine (TARC)(Change from Baseline TARC (pg/mL) level at 3 months)
- Interleukin-4 (IL-4)(Change from Baseline IL-4 (ng/mL) level at 3 months)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital