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

Pravina, K.; Ravindra, Krishna; Goudar, K.S.; Vinod, D.R.; Joshua, A.J.; Wasim, P.; Venkateshwarlu, K.; Saxena, V. S.; Agarwal, Amit

doi:10.1016/j.phymed.2007.03.010

Cited by 57 publications

(39 citation statements)

References 14 publications

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“…Phase I clinical studies confirmed the safety of bacosides in healthy male volunteers at both single and chronic dosing administered over a period of 4 weeks 7 and 6 weeks with a dose of up to 450 mg of dried water extract. 41 A water extract of Bacopa given orally up to a dose of 5 g/kg did not show toxicity in rats. The LD 50 of an alcoholic extract given orally was 17 g/kg.…”

mentioning

confidence: 91%

Effects of a Standardized Bacopa monnieri Extract on Cognitive Performance, Anxiety, and Depression in the Elderly: A Randomized, Double-Blind, Placebo-Controlled Trial

Calabrese

Gregory

Leo

et al. 2008

The Journal of Alternative and Complementary Medicine

229

159

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Objectives: Study aims were to evaluate effects of Bacopa monnieri whole plant standardized dry extract on cognitive function and affect and its safety and tolerability in healthy elderly study participants. Design: The study was a randomized, double-blind, placebo-controlled clinical trial with a placebo run-in of 6 weeks and a treatment period of 12 weeks. Setting/location: Volunteers were recruited from the community to a clinic in Portland, Oregon by public notification. Subjects: Fifty-four (54) participants, 65 or older (mean 73.5 years), without clinical signs of dementia, were recruited and randomized to Bacopa or placebo. Forty-eight (48) completed the study with 24 in each group. Interventions: Standardized B. monnieri extract 300 mg/day or a similar placebo tablet orally for 12 weeks. Outcome measures: The primary outcome variable was the delayed recall score from the Rey Auditory Verbal Learning Test (AVLT). Other cognitive measures were the Stroop Task assessing the ability to ignore irrelevant information, the Divided Attention Task (DAT), and the Wechsler Adult Intelligence Scale (WAIS) letter-digit test of immediate working memory. Affective measures were the State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression scale (CESD)-10 depression scale, and the Profile of Mood States. Vital signs were also monitored. Results: Controlling for baseline cognitive deficit using the Blessed Orientation-Memory-Concentration test, Bacopa participants had enhanced AVLT delayed word recall memory scores relative to placebo. Stroop results were similarly significant, with the Bacopa group improving and the placebo group unchanged. CESD-10 depression scores, combined state plus trait anxiety scores, and heart rate decreased over time for the Bacopa group but increased for the placebo group. No effects were found on the DAT, WAIS digit task, mood, or blood pressure. The dose was well tolerated with few adverse events (Bacopa n ϭ 9, placebo n ϭ 10), primarily stomach upset. Conclusions: This study provides further evidence that B. monnieri has potential for safely enhancing cognitive performance in the aging. 707

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mentioning

confidence: 91%

Effects of a Standardized Bacopa monnieri Extract on Cognitive Performance, Anxiety, and Depression in the Elderly: A Randomized, Double-Blind, Placebo-Controlled Trial

Calabrese

Gregory

Leo

et al. 2008

The Journal of Alternative and Complementary Medicine

229

159

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“…Multiple numbers of brahmi-based commercial ayurvedic preparations are already available in the market due to its therapeutic values (Pravina et al 2007). The plant is now listed as threatened, because the natural biomass is taken mostly from the available wild resources.…”

Section: Introductionmentioning

confidence: 99%

RAPD based genetic stability analysis among micropropagated, synthetic seed derived and hardened plants of Bacopa monnieri (L.): a threatened Indian medicinal herb

et al. 2010

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“…16 No detrimental effects were reported in another clinical study in which participants also took a daily 300 mg dose of BacoMind. 17 In a randomized, placebo-controlled study, healthy volunteers took 300 mg of KeenMind (Keen Health Pty.…”

Section: Bacopa Enhanced Memory In a Trial Of 46 Healthy Volunteersmentioning

confidence: 97%

Bacopa for the Brain: A Smart Addition to Western Medicine

AbascalKathy

Yarnell

2011

Alternative and Complementary Therapies

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This review discusses the clinical potentials of Bacopa monnieri (bacopa, water hyssop, or brahmi). Bacopa is an herb that combines adaptogenic and nervine properties. Animal and clinical studies show it to have anxiolytic, antidepressant, cognitive-enhancing, antioxidant, cholinergic, and adaptogenic actions. These properties make it a highly useful herb to help patients cope with physical and emotional stress, and the cognitive impairment that usually accompanies aging.

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

Cited by 57 publications

References 14 publications

Effects of a Standardized Bacopa monnieri Extract on Cognitive Performance, Anxiety, and Depression in the Elderly: A Randomized, Double-Blind, Placebo-Controlled Trial

Effects of a Standardized Bacopa monnieri Extract on Cognitive Performance, Anxiety, and Depression in the Elderly: A Randomized, Double-Blind, Placebo-Controlled Trial

RAPD based genetic stability analysis among micropropagated, synthetic seed derived and hardened plants of Bacopa monnieri (L.): a threatened Indian medicinal herb

Bacopa for the Brain: A Smart Addition to Western Medicine

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