Effect of Bacopa Monniera Extract on Cognition and Anxiety and Exploration of PK Properties
Condition: Cognition; Anxiety; Pharmacokinetics
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Detailed description: 
      The study is proposed to be a randomised, double blind, placebo-controlled study with
      parallel groups. The duration of the study will be 12 weeks.

      For cognition and Anxiety part, each selected subject will be paying 4 visits to clinical
      site for the whole study. Screening/selection will be done on visit 1, baseline on visit 2
      and post-intervention assessment on visit 3. Subjects will be asked to appear for an
      interview before the investigators once more within one month of completion of intervention
      to take care of issues, if any. This will be 4th and last visit.

      Each subject will be assessed at baseline (Week 1, Day 1); while post intervention assessment
      will be carried out immediately on the completion of the 12 weeks. Considering the 84 days
      duration of the study, + 3 days for the intervention period will be acceptable. The exact
      intervention duration will be documented in days for each subject.

      On each of the two measurement days (baseline and post intervention), the same test battery
      will be administered by the same examiner. The outcome measures of this battery include
      Verbal Learning and Memory, Information Processing, Attention and Interference and Anxiety.
      The test battery will be administered in English.

      On each of the measurement day the subject will spend a maximum of 1½ hours at the clinical
      site. Subjects will be examined in the morning at approximately the same time during both
      measurement days to keep conditions constant across the subjects and for baseline and post
      intervention assessments.

      Each subject participating in Pharmacokinetics (PK) part, will pay 6 visits. Visit 1 will be
      screening, Visit 2,3 and 4 for initial blood withdrawal and visit 5 will post intervention
      blood sampling. Subjects will be asked to appear for an interview before the investigators
      once more within one month of completion of intervention to take care of issues, if any,
      which will be visit 6.

      Blood sampling will be done at 0,1,2,4,8,24,48 hours and one sample at the endo of 12 weeks
      intervention.
    

Intervention name(s): Brahmi; Placebo; Brahmi; Placebo
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Other
Intervention description(s): Brahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks.; Dry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks.; Brahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days.; Placebo capsules - Dry starch filled in identical hard gelatin capsules
Other intervention name(s): Bacopa monniera; Dry Starch; Bacopa monniera; Maize Starch capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Brahmi, Cognition, Anxiety, Pharmacokinetics