Safety evaluation of BacoMind™ in healthy volunteers: A phase I study

Abstract BacoMind™ is an enriched phytochemical composition of Bacopa monniera ( B. monniera ), a common medicinal plant used in the traditional systems of medicine as a memory-enhancing agent. BacoMind™ was standardized with reference to bioactive compounds and was evaluated for short-term safety and tolerability in healthy adult volunteers. The study plan employed randomized, open label, dose escalation design. Each of 23 participants were orally given one single capsule of BacoMind™ daily for 30 days, i.e., 300 mg for first 15 days and 450 mg for next 15 days. Detailed examination of clinical, hematological, biochemical and electrocardiographic parameters done in pre and post-treatment periods did not indicate any untoward effects in any of the treated volunteers. Mild adverse events related to gastrointestinal system were observed in the trial, which subsided spontaneously. BacoMind™ was found to meet the safety criteria at the dose administered for the given duration of trial period in healthy adult volunteers.