Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Primary Purpose
Skin Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sargassum Horneri Extract group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Skin Hypersensitivity
Eligibility Criteria
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
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sargassum Horneri Extract group
Placebo group
Arm Description
This group takes Sargassum Horneri Extract for 12 weeks.
This group takes Placebo Extract for 12 weeks.
Outcomes
Primary Outcome Measures
SCORing of Atopic Dermatitis (SCORAD) total score
Change in SCORAD total score during 3 months
Secondary Outcome Measures
Patient Global assessment (PGA) score
Change in PGA score during 3 months
Investigator Global assessment (IGA) score
Change in IGA score during 3 months
Total Immunoglobulin E (IgE)
Change in total IgE (IU/mL) level during 3 months
Eosinophil counts
Change in eosinophil counts (/uL) during 3 months
Eosinophil cationic protein (ECP)
Change in ECP (μg/L) level during 3 months
Interleukin-4 (IL-4)
Change in IL-4 (ng/mL) level during 3 months
Interleukin-31 (IL-31)
Change in IL-31 (ng/mL) level during 3 months
Thymus- and activation-regulated chemokine (TARC)
Change in TARC (pg/mL) level during 3 months
Full Information
NCT ID
NCT03849378
First Posted
February 19, 2019
Last Updated
April 23, 2022
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03849378
Brief Title
Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Official Title
Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sargassum Horneri Extract group
Arm Type
Experimental
Arm Description
This group takes Sargassum Horneri Extract for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes Placebo Extract for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sargassum Horneri Extract group
Intervention Description
This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
This group takes 1,000 mg/day of Placebo Extract for 12 weeks.
Primary Outcome Measure Information:
Title
SCORing of Atopic Dermatitis (SCORAD) total score
Description
Change in SCORAD total score during 3 months
Time Frame
Change from Baseline SCORAD total score at 3 months
Secondary Outcome Measure Information:
Title
Patient Global assessment (PGA) score
Description
Change in PGA score during 3 months
Time Frame
Change from Baseline PGA score at 3 months
Title
Investigator Global assessment (IGA) score
Description
Change in IGA score during 3 months
Time Frame
Change from Baseline IGA score at 3 months
Title
Total Immunoglobulin E (IgE)
Description
Change in total IgE (IU/mL) level during 3 months
Time Frame
Change from Baseline total IgE (IU/mL) level at 3 months
Title
Eosinophil counts
Description
Change in eosinophil counts (/uL) during 3 months
Time Frame
Change from Baseline eosinophil counts (/uL) at 3 months
Title
Eosinophil cationic protein (ECP)
Description
Change in ECP (μg/L) level during 3 months
Time Frame
Change from Baseline ECP (μg/L) level at 3 months
Title
Interleukin-4 (IL-4)
Description
Change in IL-4 (ng/mL) level during 3 months
Time Frame
Change from Baseline IL-4 (ng/mL) level at 3 months
Title
Interleukin-31 (IL-31)
Description
Change in IL-31 (ng/mL) level during 3 months
Time Frame
Change from Baseline IL-31 (ng/mL) level at 3 months
Title
Thymus- and activation-regulated chemokine (TARC)
Description
Change in TARC (pg/mL) level during 3 months
Time Frame
Change from Baseline TARC (pg/mL) level at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
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