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www.flordis.com.au PO Box 1027, Crows Nest NSW 1585, Australia Tel + 61 2 9431 7200 clinically proven natural medicines KeenMind ® The world’s leading researched Bacopa monnieri Promote memory and recall, concentration and mental clarity in adults & children 4 3,5 * maximal effects evident after 12 weeks treatment in subjects aged 18 to 60 years ** ability to hold and use information “online” after 90 days treatment in subjects aged 40 to 65 years References 1. Singh, R.H . & Sing, L., Res. Ayur. Siddha 1980, 1:133-148. 2. Sharma et al, J. Res.Educ. Indian Med. 1987 1:12. 3. Stough et al, Psychopharmacology (Berl.). 2001, 156(4): 481-484. 4. Roodenrys et al 2002. Neuropsychopharmacology 27 (2):279-281 5. Stough et al, Phytotherapy Res. 2008 DOI: 10.1002/ptr.2537 Cognitive function P value Improved ‘working memory’** <0.035 Improved speed of learning* <0.042 Improved memory consolidation* <0.042 Improved speed of visual <0.018 information processing* Improved speed of early <0.05 information processing* Decreased forgetting rate* <0.03 (CDRI 08) 1,2,3,4,5 Mechanism of Action Evidence suggests modulation of the cholinergic system and/or antioxidant and metal chelating effects Actions include anti-inflammatory and neuro protective effects, relaxant properties in blood vessels and adaptogenic activity KeenMind is unique Studies indicate cognitive effects are achieved with no clinically relevant side effects Safe for use in children and adults, including the elderly Children and students – to facilitate learning Teachers, lecturers and practitioners – to increase mental performance People with high demand careers Elderly – to delay cognitive decline The result of 30 years of meticulous research and development by the Indian government’s Central Drug Research Institute (CDRI) The only Bacopa to contain optimum levels of the therapeutic bacosides A and B (55%) as well as other therapeutically relevant constituents To be taken with breakfast. Adults: 2 capsules daily Children: 1 capsule daily Ideal uses for KeenMind Safety Dosage KeenMind (CDRI 08) is clinically proven to: KeenMind is clinically proven in double-blind placebo-controlled Australian studies

KeenMind clinical review

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Page 1: KeenMind clinical review

www.flordis.com.au PO Box 1027, Crows Nest NSW 1585, Australia Tel + 61 2 9431 7200 clinically proven natural medicines

KeenMind®

The world’s leading researchedBacopa monnieri

Promote memory and recall,concentration and mental clarity inadults & children

4

3,5* maximal effects evident after 12 weeks treatment in subjects aged 18 to 60 years** ability to hold and use information “online” after 90 days treatment in subjects aged 40 to 65 years

References1. Singh, R.H . & Sing, L., Res. Ayur. Siddha 1980, 1:133-148.2. Sharma et al, J. Res.Educ. Indian Med. 1987 1:12.3. Stough et al, Psychopharmacology (Berl.). 2001, 156(4): 481-484.4. Roodenrys et al 2002. Neuropsychopharmacology 27 (2):279-2815. Stough et al, Phytotherapy Res. 2008 DOI: 10.1002/ptr.2537

Cognitive function P value

Improved ‘working memory’** <0.035Improved speed of learning* <0.042Improved memory consolidation* <0.042Improved speed of visual <0.018

information processing*Improved speed of early <0.05 information processing*Decreased forgetting rate* <0.03

(CDRI 08)

1,2,3,4,5

Mechanism of ActionEvidence suggests modulation of thecholinergic system and/or antioxidant and metal chelating effects

Actions include anti-inflammatory and neuro protective effects, relaxant properties in blood vessels and adaptogenic activity

KeenMind is unique

Studies indicate cognitive effects are achieved with no clinically relevant side effects

Safe for use in children and adults,including the elderly

Children and students – to facilitate learning

Teachers, lecturers and practitioners – to increase mental performancePeople with high demand careersElderly – to delay cognitive decline

The result of 30 years of meticulous research and development by the Indian government’s Central Drug Research Institute (CDRI)

The only Bacopa to contain optimum levels of the therapeutic bacosides A and B (55%) as well as other therapeutically relevant constituents

To be taken with breakfast.Adults: 2 capsules dailyChildren: 1 capsule daily

Ideal uses for KeenMind

Safety

Dosage

KeenMind (CDRI 08) is clinically proven to:

KeenMind is clinically proven in double-blind placebo-controlled Australian studies

Page 2: KeenMind clinical review

Background to KeenMindBacopa monnieri (Bacopa) is a perennial creeping plant found in wet, damp and marshy areas in India. Bacopa has been mentioned in the religious, social and medical treatises of India since 3000 B.C. Its use as a memory enhancing agent can be traced back to 1500 B.C. Classical Ayurveda identified the medicinal properties of Bacopa as being beneficial for mental disorders leading to memory impairment and as being efficacious even in total loss of memory.

Bacopa has been used in traditional Ayurvedic medicine for various indications including memory decline, inflammation, pain, pyrexia, epilepsy and as a sedative.

Unique FormulationKeenMind is the Bacopa extract which has been extensively investigated by the Indian government’s Central Drug Research Institute (CDRI). Phytochemical analysis of this plant was first conducted at the CDRI in 1963 and 1965 . As with most herbal medicines, a complex mix of constituents is needed for their therapeutic action, as was evidenced in the case of Bacopa. Many active constituents were identified including alkaloids, saponins, D-mannitol, betulic acid, β-sitosterol and stigmasterols, and the steroidal saponins, specifically Bacosides A and B which are believed to be essential for the clinical efficacy of this herb. The CDRI developed the unique standardised extract of Bacopa monnieri KeenMind (CDRI 08). This broad-spectrum extract is unique as it contains, along with other non-bacoside active components, optimum therapeutic levels of bacosides (55% ± 5%); levels which have not been identified in any other Bacopa product.

While Bacopa has been reported to have many actions, it isthe memory enhancing effects which have attracted most attention and pharmacological studies have supported these historical anecdotal claims for Bacopa.

Mode of ActionAlthough the exact mechanism of action of Bacopa on cognitive processes has not yet been determined, evidence suggests that it may modulate the cholinergic system and/or have antioxidant and metal chelating effects. Other purported actions include antiinflammatory, neuroprotective, anxiolytic and antidepressant effects as well as relaxant properties in blood vessels and adaptogenic activity.

Clinical Studies Over the last 30 years the CDRI has researched and developed the modern use of Bacopa. The scientific evidence for the memory enhancing effects of Bacopa is based on pre-clinical studies, and confirmed in numerous clinical trials conductedin humans. Results include: • Enhanced memory, reduced anxiety and mental fatigue and increased work output for patients with anxiety neurosis • Enhanced memory and improved learning ability for childrenThe first double blind placebo-controlled trial for KeenMind was published in 2001 . This study was conducted in Australia

KeenMind (CDRI 08)Special extract of Bacopa monnieri

®

Andrea ZangaraBSc (Clinical Psychology)Research Scholar, Medicinal Plant Research Centre, Newcastle University, UKResearch Fellow, Brain Sciences Institute, Swinburne University, AUFlordis International Business Development Manager

by Professor Con Stough and colleagues at Swinburne University to investigate the memory enhancing effects in 46 healthy subjects aged between 18 and 60 years. Results showed significantly improved speed of visual information processing, learning rate and memory consolidation, and decreased anxiety; maximal effects were evident after 12 weeks. Roodenrys and colleagues replicated the memory enhancing effects of KeenMind in 76 participants aged between 40 and 65 years . They reported a significant decrease in the rate of forgetting newly acquired information after 90 days of treatment in a sample of older individuals than previously used by Stough and colleagues (2001).

The most recent study on KeenMind was published in the Journal of Phytotherapy in August 2008 . This study of 62 healthy participants was conducted at the Brain Sciences Institute at Swinburne University in Melbourne Australia. Cognitive function tests commonly used in dementia trials (Cognitive Drug Research (CDR) computerised assessment system) were used to assess the effects of KeenMind compared to a placebo, in a randomised double blind placebo controlled trial (the gold standard in clinical research). After 90 days of treatment with 2 capsules of KeenMind the participants had significantly improved performance on “working memory” (the ability to hold information “online” in the brain and actually do something with that information) and “visual information processing” (a measure of the ability to sustain attention). Slowed information processing is one of the most prominent cognitive deficits in the elderly.

KeenMind is the result of 3 decades of intensive research worldwide and now 3 clinical studies have confirmed the potential of this natural product. These rigorously designed trials have proven that KeenMind improves memory and other measures of brain function. KeenMind is a ‘rising star’ to be closely followed in the ongoing research of evidence-based botanicals for brain health.

SafetyIn the studies conducted it appears that the cognitive effects of KeenMind are achieved with no clinically relevant side effects, even in children and elderly participants.

DosageThe capsules are best taken with breakfast. Adults take 2 capsules daily and children can take one capsule daily.

Key clinical information on KeenMind ®

The world’s leading researched and clinically proven Bacopa monnieri for use in adults and children

Promotes memory and recall, concentration and mental clarity, clinically proven in Australian published studies

The result of 30 years of meticulous research and development by the Indian government’s, Central Drug Research Institute (CDRI)

A unique broad-spectrum extract of Bacopa, and the only Bacopa to contain optimum levels of the therapeutic bacosides at 55% ± 5% as well as other therapeutically relevant constituents; these standards are not available in any other Bacopa product

1. Chatterjee et al, Ind. J. Chem., 1963, 1:212-215.2. Chatterjee et al, Ind. J. Chem., 1965, 3:24-29.3. Singh, R.H . & Sing, L., Res. Ayur. Siddha 1980, 1:133-148.4. Sharma et al, J. Res.Educ. Indian Med. 1987 1:12.5. Stough et al, Psychopharmacology (Berl.). 2001, 156(4):481-484.6. Roodenrys et al 2002. Neuropsychopharmacology 27(2):279-281 7 Stough et al, Phytotherapy Res. 2008 DOI: 10.1002/ptr.2537

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