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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sargassum Horneri Extract group | Experimental | This group takes Sargassum Horneri Extract for 12 weeks. |
|
| Placebo group | Placebo Comparator | This group takes Placebo Extract for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sargassum Horneri Extract group | Dietary Supplement | This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORing of Atopic Dermatitis (SCORAD) total score | Change in SCORAD total score during 3 months | Change from Baseline SCORAD total score at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global assessment (PGA) score | Change in PGA score during 3 months | Change from Baseline PGA score at 3 months |
| Investigator Global assessment (IGA) score | Change in IGA score during 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| Placebo group | Dietary Supplement | This group takes 1,000 mg/day of Placebo Extract for 12 weeks. |
|
| Change from Baseline IGA score at 3 months |
| Total Immunoglobulin E (IgE) | Change in total IgE (IU/mL) level during 3 months | Change from Baseline total IgE (IU/mL) level at 3 months |
| Eosinophil counts | Change in eosinophil counts (/uL) during 3 months | Change from Baseline eosinophil counts (/uL) at 3 months |
| Eosinophil cationic protein (ECP) | Change in ECP (μg/L) level during 3 months | Change from Baseline ECP (μg/L) level at 3 months |
| Interleukin-4 (IL-4) | Change in IL-4 (ng/mL) level during 3 months | Change from Baseline IL-4 (ng/mL) level at 3 months |
| Interleukin-31 (IL-31) | Change in IL-31 (ng/mL) level during 3 months | Change from Baseline IL-31 (ng/mL) level at 3 months |
| Thymus- and activation-regulated chemokine (TARC) | Change in TARC (pg/mL) level during 3 months | Change from Baseline TARC (pg/mL) level at 3 months |