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

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 tolerab...

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Bibliographic Details
Published in:	Phytomedicine (Stuttgart) Vol. 14; no. 5; pp. 301 - 308
Main Authors:	Pravina, K., Ravindra, K.R., Goudar, K.S., Vinod, D.R., Joshua, A.J., Wasim, P., Venkateshwarlu, K., Saxena, V.S., Amit, A.
Format:	Journal Article
Language:	English
Published:	Germany Elsevier GmbH 01-05-2007 Urban & Fischer Verlag
Subjects:	Administration, Oral Adolescent Adult BacoMind Bacopa Bacopa monniera Blood Chemical Analysis Dementia - prevention & control Evaluation Female Healthy volunteers Humans Male Medicinal plants Middle Aged Nootropic Agents - administration & dosage Nootropic Agents - adverse effects Nootropic Agents - therapeutic use Phytotherapy Plant Extracts - administration & dosage Plant Extracts - adverse effects Plant Extracts - therapeutic use Reference Values Safety Smart drugs and nutrients Tolerability Tolerability Healthy volunteers Safety Bacopa monniera BacoMind
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Summary:	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.
ISSN:	0944-7113 1618-095X
DOI:	10.1016/j.phymed.2007.03.010