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Completed

NCT Number: NCT03630328

Angelica Gigas Dietary Supplements and Human Immune Cells

This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. The investigators had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.

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Key information

Conditions

Innate Immune Cells

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19 to 30
  • Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR, see supporting document for normal reference ranges).
  • Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)

Exclusion criteria

  • Subjects positive for HIV, HBV and HCV (self-reported)
  • Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded. Therefore, subjects with diabetes, major cardiovascular diseases, cancer, severe hypertension, severe hepatic cirrhosis or cirrhosis of the liver, and kidney disease (self-reported) will be excluded.
  • Subjects using tobacco products, nicotine patches and excessive alcohol
  • Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study.
  • Non-English-speaking subjects

Treatment and study plan

Cogni.Q

Dietary Supplement

AGN

Placebo

Other

Placebo

Primary outcomes

  1. Neutrophil counts and NK cell counts in peripheral blood

    Time frame: 70 days

    Using CBC diff to measure neutrophil counts, NK cells number will be enumerated using flowcytometer

Secondary outcomes

  1. T cells in peripheral blood,

    Time frame: 70 days

    T cells number will be enumerated using flowcytometer

  2. Plasma concentrations of pyranocoumarins, androgens, and inflammatory/anti-inflammatory cytokines.

    Time frame: 70 days

    Determine Plasma concentrations of pyranocoumarins (as compliance marker), androgens, and inflammatory/anti-inflammatory cytokines.

  3. Lipid profiling

    Time frame: 70 days

    blood test will be done at every visit

  4. NK mRNA signature

    Time frame: 70 days

    NK mRNA signature by RNA-seq transcriptomics using RNA prepared from Pax Gene tube-preserved whole blood collected on each visit

  5. PBMC isolation for testing NK activity

    Time frame: 70 days

    PBMCs will be isolated at every blood draw and kept frozen. They will be used to determine NK cell activity in future.

  6. CMP-EGFR

    Time frame: 70 days

    blood test will be done at every visit

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Study of Angelica Gigas Dietary Supplements (Cogni.Q) and Potential Effects on Human Immune Cells

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2018
Registry last updated
Feb 27, 2026

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.