Angelica Gigas Supplement for Immune Function

Overseen By Deepkamal N Karelia, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Prescription medications, AGN supplements

Disqualifiers: HIV, HBV, HCV, diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications at least 10 days before the study, as participants taking medications regularly or within 10 days of the study are excluded.

What evidence supports the effectiveness of the treatment Cogni.Q for immune function?

Research on Angelica gigas, a component of Cogni.Q, shows it can boost immune responses by activating certain immune cells and reducing inflammation. It has been found to enhance immune function in mice, suggesting potential benefits for improving immunity. ^{1 2 3 4 5}

Is Angelica gigas safe for human consumption?

Research on Angelica gigas suggests it is generally safe for oral consumption, as studies in rats showed no significant adverse effects even at high doses, and it was not found to be genotoxic (not damaging to DNA). ^{3 6 7 8 9}

What makes the Angelica Gigas supplement unique for immune function?

The Angelica Gigas supplement, used in the treatment Cogni.Q, is unique because it contains polysaccharides that stimulate the immune system by activating natural killer cells and T cells, which are important for fighting infections and potentially cancer. This is different from other treatments as it enhances the body's natural immune response through a specific mechanism involving toll-like receptor 4 (TLR4), which is not commonly targeted by standard immune-boosting therapies. ^{1 2 3 5 6}

Research Team

Junxuan Lu, Ph.D.

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

This trial is for adults weighing 110 to 240 pounds with a BMI of 19-30, normal liver and kidney function, and blood pressure below the high range. It's not for those with HIV/HBV/HCV, on regular prescription meds or who have major health issues like diabetes or severe organ diseases. Smokers, heavy drinkers, non-English speakers, and users of certain supplements can't join.

Inclusion Criteria

Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)

I weigh between 110 to 240 pounds and my BMI is between 19 to 30.

My liver and kidney functions are normal.

Exclusion Criteria

Subjects positive for HIV, HBV, and HCV (self-reported)

Subjects using tobacco products, nicotine patches, and excessive alcohol

I haven't taken supplements with AGN like Cogni.Q or EstroG-100 in the last 10 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cogni.Q or placebo capsules for 21 days to assess immune cell response

3 weeks

Daily administration, with blood draws at each visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood tests to measure immune cell activity

7 weeks

Regular visits for blood tests

Treatment Details

Interventions

• Cogni.Q
• Placebo

Trial Overview The study tests if Korean Angelica root extract (Cogni.Q) boosts immune cells compared to a placebo. Participants will take either Cogni.Q vegicaps or dummy pills without knowing which one they're getting. The focus is on whether this supplement increases neutrophils and NK cells that fight infections and cancer.

Participant Groups

Group I: Cogni.Q Experimental Treatment 2 Interventions

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

Group II: Placebo Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

References

1. England pubmed.ncbi.nlm.nih.gov

TLR4-dependent effects of ISAg treatment on conventional T cell polarization in vivo. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Anti-cancer activity of Angelica gigas by increasing immune response and stimulating natural killer and natural killer T cells. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-allergic effects and mechanisms of action of the ethanolic extract of Angelica gigas in dinitrofluorobenzene-induced inflammation models. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Immune-enhancement effects of Angelica gigas Nakai extracts via MAPK/NF-ƙB signaling pathways in cyclophosphamide-induced immunosuppressed mice. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Decursinol Angelate Ameliorates Dextran Sodium Sulfate-Induced Colitis by Modulating Type 17 Helper T Cell Responses. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety evaluation of Angelica gigas: Genotoxicity and 13-weeks oral subchronic toxicity in rats. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Detection of the Content of Two Coumarins, IM and ISOIM, and Their Mechanism of Action on Colitis Rats in Angelica albicans. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Protection against beta-amyloid peptide-induced memory impairment with long-term administration of extract of Angelica gigas or decursinol in mice. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating the Memory Enhancing Effects of Angelica gigas in Mouse Models of Mild Cognitive Impairments. [2020]