Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Not Applicable

Completed

• Conditions: Skin Hypersensitivity
• Interventions: Dietary Supplement: Placebo group; Dietary Supplement: Sargassum Horneri Extract group

• Registration Number: NCT03849378
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-23
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	This group takes Placebo Extract for 12 weeks.
Sargassum Horneri Extract group	Sargassum Horneri Extract group	This group takes Sargassum Horneri Extract for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient Global assessment (PGA) score	Change from Baseline PGA score at 3 months	Change in PGA score during 3 months
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 cationic protein (ECP)	Change from Baseline ECP (μg/L) level at 3 months	Change in ECP (μg/L) 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
Eosinophil counts	Change from Baseline eosinophil counts (/uL) at 3 months	Change in eosinophil counts (/uL) 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
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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of