Immulina TM for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Mississippi Medical Center, Jackson, MS
Healthy Subjects (HS)
Immulina TM - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 20 weeks

20 weeks
Cytotoxic T lymphocyte (CTL) number
Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts
Influenza A IgG antibody, U/mL
Influenza B IgG antibody, U/mL
Natural Killer (NK) cell count
Natural Killer cell (NK)-mediated cytotoxicity
Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL
serum Interferon alpha, pg/mL
serum Interferon gamma, pg/mL

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Immulina TM 800 mg/day
1 of 4
Immulina TM 400 mg/day
1 of 4
Immulina TM 200 mg/day
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

472 Total Participants · 4 Treatment Groups

Primary Treatment: Immulina TM · Has Placebo Group · N/A

Immulina TM 800 mg/day
DietarySupplement
Experimental Group · 1 Intervention: Immulina TM · Intervention Types: DietarySupplement
Immulina TM 400 mg/day
DietarySupplement
Experimental Group · 1 Intervention: Immulina TM · Intervention Types: DietarySupplement
Immulina TM 200 mg/day
DietarySupplement
Experimental Group · 1 Intervention: Immulina TM · Intervention Types: DietarySupplement
Placebo
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 weeks
Closest Location: University of Mississippi Medical Center · Jackson, MS
Photo of mississippi 1Photo of mississippi 2Photo of mississippi 3
2011First Recorded Clinical Trial
2 TrialsResearching Healthy Subjects (HS)
512 CompletedClinical Trials

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
762 Previous Clinical Trials
640,234 Total Patients Enrolled
27 Trials studying Healthy Subjects (HS)
4,089 Patients Enrolled for Healthy Subjects (HS)
University of Mississippi Medical CenterLead Sponsor
158 Previous Clinical Trials
208,182 Total Patients Enrolled
1 Trials studying Healthy Subjects (HS)
15 Patients Enrolled for Healthy Subjects (HS)
Gailen D Marshall, Jr., MD, PhDPrincipal InvestigatorUniversity of Mississippi Medical Center
3 Previous Clinical Trials
158 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 59 or 65 and above.
You have a chronic illness that is stable as evidenced by no changes in medical regimens within 30 days of enrollment.
You are able to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.