Angelica Gigas Dietary Supplements and Human Immune Cells

NCT ID: NCT03630328

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Innate Immune Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cogni.Q

800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days

Group Type EXPERIMENTAL

Cogni.Q

Intervention Type DIETARY_SUPPLEMENT

AGN

Placebo

Intervention Type OTHER

Placebo

Placebo

Two capsules in the morning and two capsules in the evening for 21 days

Group Type PLACEBO_COMPARATOR

Cogni.Q

Intervention Type DIETARY_SUPPLEMENT

AGN

Placebo

Intervention Type OTHER

Placebo

Interventions

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Cogni.Q

AGN

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Junxuan Lu

Professor of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junxuan Lu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00008009

Identifier Type: -

Identifier Source: org_study_id

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