Skin Hypersensitivity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSargassum Horneri Extract group
This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
DIETARY_SUPPLEMENTPlacebo group
This group takes 1,000 mg/day of Placebo Extract for 12 weeks.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Atopy by Hanifin & Rajka diagnostic criteria * SCORAD \< 40
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORing of Atopic Dermatitis (SCORAD) total score | Change from Baseline SCORAD total score at 3 months | Change in SCORAD total score during 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global assessment (IGA) score | Change from Baseline IGA score at 3 months | Change in IGA score during 3 months |
| Total Immunoglobulin E (IgE) | Change from Baseline total IgE (IU/mL) level at 3 months | Change in total IgE (IU/mL) level during 3 months |
| Eosinophil counts | Change from Baseline eosinophil counts (/uL) at 3 months | Change in eosinophil counts (/uL) during 3 months |
| Patient Global assessment (PGA) score | Change from Baseline PGA score at 3 months | Change in PGA score during 3 months |
| Interleukin-4 (IL-4) | Change from Baseline IL-4 (ng/mL) level at 3 months | Change in IL-4 (ng/mL) level during 3 months |
| Interleukin-31 (IL-31) | Change from Baseline IL-31 (ng/mL) level at 3 months | Change in IL-31 (ng/mL) level during 3 months |
| Thymus- and activation-regulated chemokine (TARC) | Change from Baseline TARC (pg/mL) level at 3 months | Change in TARC (pg/mL) level during 3 months |
| Eosinophil cationic protein (ECP) | Change from Baseline ECP (μg/L) level at 3 months | Change in ECP (μg/L) level during 3 months |
Countries
South Korea
Outcome results
None listed