Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Skin Hypersensitivity

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Sargassum Horneri Extract group

Study type: Interventional

Funder types: Other

Identifiers

NCT03849378

02-2018-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Sargassum Horneri Extract group

Experimental group

Description:

This group takes Sargassum Horneri Extract for 12 weeks.

Treatment:

Dietary Supplement: Sargassum Horneri Extract group

Placebo group

Placebo Comparator group

Description:

This group takes Placebo Extract for 12 weeks.

Treatment:

Dietary Supplement: Placebo group