Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

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.

Study Overview

• Status: Completed
• Conditions: Skin Hypersensitivity
• Intervention / Treatment: Dietary supplement: Sargassum Horneri Extract group; Dietary supplement: Placebo group

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sargassum Horneri Extract group; This group takes Sargassum Horneri Extract for 12 weeks.	Dietary supplement: Sargassum Horneri Extract group; This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
Placebo Comparator: Placebo group; This group takes Placebo Extract for 12 weeks.	Dietary supplement: Placebo group; This group takes 1,000 mg/day of Placebo Extract for 12 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 02-2018-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No