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Dietary Supplement

Immulina Supplement for Long COVID

N/A
Recruiting
Led By Gailen D Mashall, Jr., MD, PhD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will study the effects of a natural dietary supplement on blood chemicals associated with inflammation in patients with long COVID.

Who is the study for?
Adults aged 18-99 with normal body temperature and not pregnant or breastfeeding can join this trial. They must be willing to avoid other dietary supplements for 4 weeks before the study, swallow size 4 capsules, and have blood drawn. People with digestive disorders, recent drug/alcohol abuse, or on blood thinners cannot participate.Check my eligibility
What is being tested?
The study is testing Immulina TM, a natural supplement thought to reduce inflammation in long COVID patients. Participants will either receive Immulina TM or a placebo without knowing which one they're taking to compare effects on blood chemicals linked to inflammation.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to allergies or sensitivities to Immulina's ingredients like cellulose. Since it's a dietary supplement being tested against a placebo, side effects might be minimal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma CRP (C-Reactive Protein, ng/mL)
Plasma D-Dimer, pg/mL
Plasma IL-6 (Interleukin 6, pg/mL)
Secondary outcome measures
Cytolytic T lymphocyte (CTL) number
FSS
Natural Killer (NK) cell count
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immulina TM 800 mg/dayExperimental Treatment1 Intervention
Immulina Dietary supplementation (200 mg per capsule) 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 8 weeks duration
Group II: PlaceboPlacebo Group1 Intervention
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration

Find a Location

Who is running the clinical trial?

University of NebraskaOTHER
539 Previous Clinical Trials
1,144,614 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
304 Previous Clinical Trials
181,316 Total Patients Enrolled
West Virginia UniversityOTHER
176 Previous Clinical Trials
60,108 Total Patients Enrolled

Media Library

Immulina TM (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05524532 — N/A
Long COVID Syndrome Research Study Groups: Immulina TM 800 mg/day, Placebo
Long COVID Syndrome Clinical Trial 2023: Immulina TM Highlights & Side Effects. Trial Name: NCT05524532 — N/A
Immulina TM (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05524532 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the stipulated age limit for this trial exclude those aged below sixty?

"This clinical trial is recruiting patients aged 18 to 99. For minors and those 65 or above, there are 137 studies for the former group and 900 available for the latter one."

Answered by AI

Are volunteers able to participate in this trial at present?

"The details provided by clinicaltrials.gov show that this medical trial is not currently enlisting participants, having been initially posted on September 28th 2022 and last updated on August 31st 2022. Nevertheless, there are 1032 other trials actively seeking enrolment at the present moment."

Answered by AI

Do I qualify to participate in this experiment?

"This trial is enrolling 120 individuals aged 18 to 99 years with atrial premature complexes. To be deemed eligible, candidates must demonstrate good English literacy, not have participated in a clinical study recently (within the last 30 days), and possess bodily temperature within the range of 36.1°C and 37.7°C degree celsius. Women are required to use an accepted form of birth control or have been postmenopausal for two years minimum; additionally, they must abstain from any dietary supplements 4 weeks prior to Study Day 1 until completion date. All participants will need to fast 2 hours before blood samples are taken and willingly swallow capsules"

Answered by AI

Could you explain the purpose of this clinical investigation?

"The primary result of this trial, which is to be observed over a 12 week period, will be measurements of Plasma IL-6 (Interleukin 6, pg/mL). As for the secondary objectives that need to be measured are: differences in SARS-CoV-2-specific antibody immune responses between baseline and 12 weeks, variations in Fatigue Severity Scale questionnaire results representing PASC related fatigue symptoms from baseline to 12 weeks ,and dissimilarities in Symptom Burden Questionnaire for Long COVID with outcomes indicating patient reported experiences."

Answered by AI

Who else is applying?

What site did they apply to?
University of Mississippi Medical Center
University of Hawaii
Tulane University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Effects of Immulina TM Supplements With PASC Patients
2023. "Effects of Immulina TM Supplements With PASC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05524532.
All > Honolulu
~43 spots leftby Sep 2024
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