Human Clinical Trials

Influenza (January-July, 2010)
The primary objective of this Study was preliminary assessment of the efficacy of Laub BioChem’s VFI Humic Acid® on flu symptoms as gauged by the alleviation of symptoms after 7 and 14 days of treatment in adults with influenza A or B.  This was a multi-center, randomized, double-blind, placebo-controlled, parallel-group Study with a single 14-day treatment period.  The Study was conducted at two sites in the US: Advanced Research Institute, Inc. (Trinity, FL) and Vertitas Research Corp. (Miami Lakes, FL).  The Study was managed by KGK Synergize, Inc.

Results
Subjects on VFI Humic Acid® reported higher scores for cough, fever, runny nose, stuffy nose, aches, chills, sneezing, earaches and fatigue on Day 1.  After supplementation for 7 days with VFI Humic Acid®, symptom scores improved by a greater percentage than did those for Subjects taking Placebo for the same duration for cough (61.9% vs. 36.8%), fever (91.7% vs. 81.8%), runny nose (66.7% vs. 62.5%), stuffy nose (66.7% vs. 62.5%), aches (86.4% vs. 62.5%), chills (91.7% vs. 66.7%), sneezing (70.6% vs. 61.5%) and fatigue (80.0% vs. 54.5%).  Mean scores for Subjects on VFI Humic Acid® were also lower than for those on Placebo after 7 days of treatment for cough, fever, aches, chills and fatigue in spite of being worse than Placebo on Day 1.

 

Conclusions
VFI Humic Acid® demonstrated clinically-noteworthy efficacy on influenza viral infection in the 2010 flu season by improving flu-related symptoms, cytokine response, immune-system modulators CD4+ and CD8+, and VAS scores when provided as 6 x 250-mg tablets daily for 14 days within the demographic of Subjects studied.

 

Clinical Trial Protocol

IRB Protocol Approval

Clinical Trial Summary

Clinical Trial Final Report

 

Influenza Therapy (Scheduled for 2011-2012)
This will be a randomized, double-blind, placebo controlled, parallel group efficacy Study of 100 Subjects with a 14-day treatment period.  At screening (visit 1) medical history and concomitant therapies will be reviewed.  A physical exam will be conducted; heart rate, blood pressure and oral temperature will be measured.  A self-administered symptoms questionnaire and VAS will be completed.  Eligible subjects will be randomized to treatment group and begin treatment on the same day as the screening visit.  Peripheral blood will be collected to determine CBC (includes WBC differential), T lymphocyte counts (CD4+, CD8+), TNF-α, IL-8, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin.  Viral load will also be measured by a method to be determined.  A urine pregnancy test will be done on all females of childbearing potential.  Investigational product and diary will be dispensed and subjects will be instructed on use.  Subjects will be provided with electronic thermometer to record oral temperature daily.

Subjects will return to the clinic on day 2 (visit 2), day 4 (visit 3), day 7 (visit 4) and day 14 (visit 5).  Heart rate, blood pressure and oral temperature will be measured.  VAS will be completed.  Blood will be collected for CBC, T lymphocyte counts, TNF-α, IL-8, and viral load.  Investigational product and diary will be returned and dispensed/ redispensed; compliance, concomitant therapies, and adverse events will be assessed.

Subjects will return to the clinic on day 14 (visit 5 – end of study).  Heart rate, blood pressure and oral temperature will be measured.  VAS will be completed.  Blood will be collected for CBC, T lymphocyte counts, TNF-α, IL-8, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin.  Investigational product and diary will be returned; compliance, concomitant therapies, and adverse events will be assessed.
Diary will be used by subjects to record daily symptom scores, investigational product use, concomitant therapy use including treatments taken for symptoms, and changes in health status including adverse effects.

Subjects will be allowed to use concomitant therapies for the treatment of symptoms (ie antipyretics, expectorants, throat lozenges).  Subjects will be asked to refrain from taking acetaminophen, aspirin, ibuprofen or NSAID within the 4 hours prior to temperature readings.

Primary Endpoints:

  • Alleviation of symptoms
  • Viral Load

 

Secondary Endpoints

  • Visual analog scale (VAS) 0-100 mm, for ability to perform usual activities
  • Doses of concomitant therapies for symptom treatment
  • Immunological markers (WBC differential, CD4+, CD8+, TNF-α, IL-8)

 

Influenza Prophylaxis (Scheduled for 2012-2013)
This will be a randomized, double-blind, placebo controlled, parallel group efficacy pilot Study of 200 Subjects with a 16-week treatment period.  At screening (visit 1) medical history and concomitant therapies will be reviewed.  A physical exam will be conducted; heart rate, blood pressure and oral temperature will be measured.  Eligible subjects will be randomized to treatment group and begin treatment on the same day as the screening visit.  Peripheral blood will be collected to determine CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin.  A urine pregnancy test will be done on all females of childbearing potential.  Investigational product and diary will be dispensed and subjects will be instructed on use. 

Subjects will return to the clinic monthly to determine compliance and review adverse events.  Subjects will be instructed to come into the clinic upon feeling cold- and flu-like symptoms and will be required to complete a symptom severity questionnaire to be determined during protocol development.

At the final visit heart rate, blood pressure and oral temperature will be measured.  Blood will be collected for CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin.  Investigational product and diary will be returned; compliance, concomitant therapies, and adverse events will be assessed.

Diary will be used by subjects to record investigational product use, concomitant therapy use including treatments taken for symptoms, and changes in health status including adverse effects.

Primary Endpoints

  • Prevention of symptoms

 

Secondary Endpoints

  • Doses of concomitant therapies for symptom treatment