Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Pusan National University Yangsan Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Skin Hypersensitivity

Interventions

Sargassum Horneri Extract groupDIETARY_SUPPLEMENT

This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.

Placebo groupDIETARY_SUPPLEMENT

This group takes 1,000 mg/day of Placebo Extract for 12 weeks.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

SCORing of Atopic Dermatitis (SCORAD) total score

Change in SCORAD total score during 3 months

Time frame: Change from Baseline SCORAD total score at 3 months

Secondary Outcomes

Patient Global assessment (PGA) score

Change in PGA score during 3 months

Time frame: Change from Baseline PGA score at 3 months

Investigator Global assessment (IGA) score

Change in IGA score during 3 months

Time frame: Change from Baseline IGA score at 3 months

Total Immunoglobulin E (IgE)

Change in total IgE (IU/mL) level during 3 months

Time frame: Change from Baseline total IgE (IU/mL) level at 3 months

Eosinophil counts

Change in eosinophil counts (/uL) during 3 months

Time frame: Change from Baseline eosinophil counts (/uL) at 3 months

Eosinophil cationic protein (ECP)

Change in ECP (μg/L) level during 3 months

Time frame: Change from Baseline ECP (μg/L) level at 3 months

Interleukin-4 (IL-4)

Change in IL-4 (ng/mL) level during 3 months

Time frame: 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

Time frame: Change from Baseline IL-31 (ng/mL) level at 3 months

Data from ClinicalTrials.gov

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