Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Skin Hypersensitivity Clinical Trial

Official title:

Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849378
• Other study ID #: 02-2018-002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Skin Hypersensitivity

Intervention

Dietary Supplement:
• Sargassum Horneri Extract group
This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
• Placebo group
This group takes 1,000 mg/day of Placebo Extract for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Global assessment (PGA) score	Change in PGA score during 3 months	Change from Baseline PGA score at 3 months
Secondary	Investigator Global assessment (IGA) score	Change in IGA score during 3 months	Change from Baseline IGA score at 3 months
Secondary	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
Secondary	Eosinophil counts	Change in eosinophil counts (/uL) during 3 months	Change from Baseline eosinophil counts (/uL) at 3 months
Secondary	Eosinophil cationic protein (ECP)	Change in ECP (µg/L) level during 3 months	Change from Baseline ECP (µg/L) level at 3 months
Secondary	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
Secondary	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
Secondary	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