drugset / Trial / NCT06213077

The Effects of a Nitrate Supplementation on Erectile Function

NCT06213077

Unknown 20 enrolled RHA Investments Ltd
RandomizedCrossoverDouble-blindTreatment

Summary

Twenty (20) individuals to be recruited from Ballantyne Medical Associates in Charlotte, NC, without any significant chronic medical history. These patients are general patients for primary care that meet inclusion criteria. Patients will be screened and enrolled by Dr. Bauer and his delegated research staff upon patient consult. Patients will be informed of the purpose of the study including risks, benefits, and alternative treatments to the study. After the potential participants have been given the opportunity to ask questions and have their questions answered, they will be asked to sign an informed consent prior to any study-specific procedures being performed. Blinded test product will be randomly assigned to study subjects. Test group 1 will be dosed with a placebo capsule taken two capsules once daily Test group 2 will be dosed with Berkeley Life capsules taken two capsules once daily. At baseline, prior to crossover to the other treatment, and at the study's conclusion, NO levels will be monitored using salivary nitric oxide test strips. Both test groups will remain on their existing treatment protocol throughout the study.

Timeline

Start
2023-12-12
Primary completion
2024-04-30
Completion
2024-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified
Comparator Tadalafil Small molecule

Indications