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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a dietary supplement made from Korean Angelica root, known as Cogni.Q, might boost the immune system. Specifically, the researchers aim to determine if the supplement can increase two important immune cells: neutrophils, which fight bacteria, and natural killer cells, which target viruses and cancer cells. Participants will take either the Angelica supplement or a placebo for 21 days to test the supplement's effectiveness. Ideal candidates weigh between 110 to 240 pounds, have normal liver and kidney function, and do not take regular prescription medications. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on immune health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cogni.Q, which includes Korean Angelica root extract, is generally safe. Studies have found that taking the recommended dose of 400 mg twice a day does not harm the liver or kidneys and does not affect certain blood health indicators. One study indicated that even higher doses are safe for people with prostate cancer, as it was well-tolerated and did not cause serious side effects. Overall, this evidence suggests that Cogni.Q is unlikely to cause harm when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cogni.Q because it harnesses the power of Angelica gigas, a natural ingredient, to potentially enhance immune function. Unlike current treatments that often involve synthetic compounds, Cogni.Q stands out with its botanical origin, offering a more natural approach. Additionally, its dosing regimen of 800 mg per day is designed to deliver concentrated benefits quickly, with results expected in just 21 days. This unique combination of natural ingredients and speedy action differentiates it from existing options, sparking interest among researchers.

What evidence suggests that this treatment might be an effective treatment for immune function?

Research has shown that Angelica gigas, the main ingredient in Cogni.Q, can boost the immune system. Studies have found that a single dose of Korean Angelica increases the number of certain immune cells, such as neutrophils and natural killer (NK) cells, in the blood within 24 hours. Neutrophils combat bacteria, while NK cells target virus-infected and cancer cells. This trial will evaluate Cogni.Q's potential to strengthen the body's defenses against infections and diseases. The supplement may activate immune cells and reduce inflammation. ^{1 6 7 8 9}

Who Is on the Research Team?

Junxuan Lu, Ph.D.

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

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)

My liver and kidney functions are normal.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/79/13_Supplement/4212/636118/Abstract-4212-A-pilot-clinical-trial-to-study-the

A pilot clinical trial to study the effects of Angelica gigas dietary ... We expect to detect an increase in both neutrophil and NK cell counts compared to placebo. Positive data from our proposed trial will be the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03630328?term=AREA%5BConditionSearch%5D(Angelica)&rank=1

Angelica Gigas Dietary Supplements and Human Immune ... 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 ...

3. withpower.com withpower.com/trial/phase-1-2019-cbd13

Angelica Gigas Supplement 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449711/

Immune-enhancement effects of Angelica gigas Nakai ... In conclusion, our overall findings revealed the immune-enhancement potential of AGN as an immunostimulant under immunosuppressed conditions. Therefore, we ...

5. clinicaltrial.be clinicaltrial.be/en/details/67640?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Angelica Gigas Dietary Supplements and Human Immune ... This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12312515/

Efficacy and safety of SH003 on immune function Angelica Gigas Radix and Trichosanthis Radix are also notable for their medicinal properties, ranging from anti-inflammatory effects to ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2023.41.6_suppl.TPS404

Angelica herbal supplement AGN-CognI.Q acute dose ... We hypothesize that CognI.Q at the higher doses has an acceptable safety profile in prostate cancer patients and pharmacokinetics (PK) exposure ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11785709/

Angelica gigas Nakai (Korean Dang-gui) Root Alcoholic ... AGN root ethanolic extracts have been marketed as dietary supplements in the United States for memory health and pain management.

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.170

A double-blinded, placebo-controlled, cross-over pilot trial ... CognI.Q supplement at the current recommended dose (400 mg, twice per day) did not impair hepatic integrity or renal function, nor did it modulate select ...