Clinical trial NCT03849378: Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Official title: Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Hypersensitivity
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SCORing of Atopic Dermatitis (SCORAD) total score
timeFrame: Change from Baseline SCORAD total score at 3 months
Secondary outcomes:
measure: Patient Global assessment (PGA) score
timeFrame: Change from Baseline PGA score at 3 months
measure: Investigator Global assessment (IGA) score
timeFrame: Change from Baseline IGA score at 3 months
measure: Total Immunoglobulin E (IgE)
timeFrame: Change from Baseline total IgE (IU/mL) level at 3 months
measure: Eosinophil counts
timeFrame: Change from Baseline eosinophil counts (/uL) at 3 months
measure: Eosinophil cationic protein (ECP)
timeFrame: Change from Baseline ECP (μg/L) level at 3 months
measure: Interleukin-4 (IL-4)
timeFrame: Change from Baseline IL-4 (ng/mL) level at 3 months
measure: Interleukin-31 (IL-31)
timeFrame: Change from Baseline IL-31 (ng/mL) level at 3 months
measure: Thymus- and activation-regulated chemokine (TARC)
timeFrame: Change from Baseline TARC (pg/mL) level at 3 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: