Glossary



Safety and Efficacy Trial

Sanesco International, Inc.
Jan-Apr 2005

Purpose:

Prior to going to market, Sanesco chose to perform a clinical study in conjunction with specific Integrative practitioners to determine if their TNT formulations could affect a clinical and laboratory response in a short time: only 30 days.

Subjects and Methods:

We had 13 physicians provide 45 patients to participate in the study, of which 33 completed the program.

  • Of those 33 participants there were 27 females and 6 males.
  • Patients ranged in age from 14 to 88 years old with a median age of 46.

All participants were provided a 30 day supply of our inhibitory product, Prolent and our excitatory product, Procite. The product was provided to the participants after baseline testing was completed.

Baseline testing was performed on a urine sample, collected 2 (two) hours after rising. Testing methodology was EIA for 4 (four) neurotransmitters: serotonin, dopamine, nor-epinephrine and epinephrine.

Analysis of their baseline results was performed by research staff at Sanesco and one of 3 protocols was assigned to each patient.

  • Protocol 1 consisted of taking the inhibitory for 2 weeks in the evening and adding the excitatory on week 3 and 4 in the morning.
  • Protocol 2 consisted of inhibitory only in the evening for 4 weeks.
  • Protocol 3 consisted of taking inhibitory in the evening for week 1 and adding the excitatory in the morning for weeks 2, 3 and 4.

Patients were asked to retest at the 2 week and 4 week mark and complete a symptom questionnaire.

  • 82% of those showed a decrease in their major clinical complaints
  • Over 80% showed improved balance between their excitatory and inhibitory neurotransmitters on their laboratory results

Conclusion:

Over 80% of the 33 study participants who completed the program experienced a change in their urinary neurotransmitter levels and/or clinical improvement with the formulations and assigned protocols, within the 30 days. We assume that if greater than 80% of patients experience improvement within 30 days and only on the initial protocols, a higher percentage should experience clinical response when participating in the total protocol designed for the individual by Sanesco.

The results were reviewed by:
Research Scientist, Jason Truesdale, MS
Medical Director, Denise Mark, MD.