Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedApril 26, 2022
April 1, 2022
3.1 years
February 19, 2019
April 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Patient Global assessment (PGA) score
Change from Baseline PGA score at 3 months
Investigator Global assessment (IGA) score
Change from Baseline IGA score at 3 months
Total Immunoglobulin E (IgE)
Change from Baseline total IgE (IU/mL) level at 3 months
Eosinophil counts
Change from Baseline eosinophil counts (/uL) at 3 months
Eosinophil cationic protein (ECP)
Change from Baseline ECP (μg/L) level at 3 months
- +3 more secondary outcomes
Study Arms (2)
Sargassum Horneri Extract group
EXPERIMENTALThis group takes Sargassum Horneri Extract for 12 weeks.
Placebo group
PLACEBO COMPARATORThis group takes Placebo Extract for 12 weeks.
Interventions
This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
This group takes 1,000 mg/day of Placebo Extract for 12 weeks.
Eligibility Criteria
You may qualify if:
- Atopy by Hanifin \& Rajka diagnostic criteria
- SCORAD \< 40
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee, MD
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 21, 2019
Study Start
January 1, 2019
Primary Completion
February 14, 2022
Study Completion
February 28, 2022
Last Updated
April 26, 2022
Record last verified: 2022-04