Effect of Bacopa Monniera Extract on Cognition and Anxiety and Exploration of PK Properties

Summary

The Indian Ayurvedic herb Brahmi (Bacopa monniera) has been used to improve cognitive functions in Indian sub-continent for many years and previous intervention studies have shown positive effects of Brahmi on cognitive performance in adults. However, the studies are conducted on various fractions and extracts and there is high likelihood of variability of composition amongst the fractions/extracts tested in these studies. Furthermore, although the findings of the previous studies overlap to some extent, they are not consistent and there is a need to replicate these findings.

Further, even though Brahmi has been studied for its chemical composition and its therapeutic benefits as a whole, there are still severe gaps with respect to the complete composition of the Brahmi plant or its extracts. No published data exist on the Pharmacokinetics (PK) properties of Brahmi components. Hitherto, the evidence and the mechanistic details are still speculative and the biological activity is still phenomenological. Because of this severe knowledge gap, this study will try to repeat the findings on cognitive performance and at the same time also explore the plasma levels of its components in order to initiate the understanding of ADME aspects and its linkages to the biological effect.

Conditions

• Cognition
• Anxiety
• Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Brahmi

Brahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks.

OTHER

Placebo

Dry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks.

DIETARY_SUPPLEMENT

Brahmi

Brahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days.

OTHER

Placebo

Placebo capsules - Dry starch filled in identical hard gelatin capsules

Sponsors & Collaborators

• St. John's Research Institute

  collaborator OTHER

• Unilever R&D

  lead INDUSTRY

Principal Investigators

• Krishnamachari Srinivasan · St. John's Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2010-07-31

Completion

2010-07-31

Countries

• India

Study Locations