Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Conditions
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Skin Hypersensitivity

Intervention / Treatment
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* Dietary Supplement: Sargassum Horneri Extract group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sargassum Horneri Extract group<br>This group takes Sargassum Horneri Extract for 12 weeks. | Dietary Supplement: Sargassum Horneri Extract group<br>* This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.<br>|
| Placebo Comparator: Placebo group<br>This group takes Placebo Extract for 12 weeks. | Dietary Supplement: Placebo group<br>* This group takes 1,000 mg/day of Placebo Extract for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |