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Completed

NCT Number: NCT03849378

Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

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.

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Key information

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sargassum Horneri Extract group

Dietary Supplement

This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.

Placebo Group

Dietary Supplement

This group takes 1,000 mg/day of Placebo Extract for 12 weeks.

Primary outcomes

  1. SCORing of Atopic Dermatitis (SCORAD) total score

    Time frame: Change from Baseline SCORAD total score at 3 months

    Change in SCORAD total score during 3 months

Secondary outcomes

  1. Patient Global assessment (PGA) score

    Time frame: Change from Baseline PGA score at 3 months

    Change in PGA score during 3 months

  2. Investigator Global assessment (IGA) score

    Time frame: Change from Baseline IGA score at 3 months

    Change in IGA score during 3 months

  3. Total Immunoglobulin E (IgE)

    Time frame: Change from Baseline total IgE (IU/mL) level at 3 months

    Change in total IgE (IU/mL) level during 3 months

  4. Eosinophil counts

    Time frame: Change from Baseline eosinophil counts (/uL) at 3 months

    Change in eosinophil counts (/uL) during 3 months

  5. Eosinophil cationic protein (ECP)

    Time frame: Change from Baseline ECP (μg/L) level at 3 months

    Change in ECP (μg/L) level during 3 months

  6. Interleukin-4 (IL-4)

    Time frame: Change from Baseline IL-4 (ng/mL) level at 3 months

    Change in IL-4 (ng/mL) level during 3 months

  7. Interleukin-31 (IL-31)

    Time frame: Change from Baseline IL-31 (ng/mL) level at 3 months

    Change in IL-31 (ng/mL) level during 3 months

  8. Thymus- and activation-regulated chemokine (TARC)

    Time frame: Change from Baseline TARC (pg/mL) level at 3 months

    Change in TARC (pg/mL) level during 3 months

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2019
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.