Angelica Gigas Dietary Supplements and Human Immune Cells

Penn State Health

Status: Active, not recruiting

Conditions: Innate Immune Cells

Treatments: Other: Placebo; Dietary Supplement: Cogni.Q

Study type: Interventional

Funder types: Other

Identifiers

NCT03630328

STUDY00008009

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Cogni.Q

Experimental group

Description:

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

Treatment:

Other: Placebo

Dietary Supplement: Cogni.Q

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Dietary Supplement: Cogni.Q