CognitionYaaddashtNCT02462642
Effect of Bacopa Monniera Extract on Cognition and Anxiety and Exploration of PK Properties
A study testing Brahmi in people with Cognition and Anxiety, run by Unilever R&D at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Anxiety, Pharmacokinetics
- What is being tested?
- Brahmi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects in the age between 35 and 60 at start of the study
- BMI BETWEEN 20 and 30 kg/m2
- Apparently mentally and physically healthy
- Willing to refrain from foods and supplements that contain caffeine, such as coffee, tea, chocolate, cola and energy drinks from 9 PM on the evening before each test day.
- Willing to refrain from supplements that are likely to have an effect on cognitive performance
- Having Haemoglobin counts more than 11 mg/ DL and normal blood profile in Physician's opinion (only for pharmacokinetic part)
Who cannot join
- Being on a medically prescribed- or slimming diet
- Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination
- Using herbal supplements or dietary supplements meant for improving cognitive performance
- Undergoing medical treatment that may interfere with the study outcome
- Using systemic antibiotics in the period of 3 months prior to or during the run-in period of the study
- Scoring above the cut off 9 on the GHQ28
Show all 14Show fewer
- Pregnancy during the study period or in the six months prior to pre-study investigation
- Reported lactating 6 weeks before pre-study investigation and during the study
- Intense exercise >10 h/w
- Being colour-blind or dyslexic
- Hearing or vision impairments
- High alcohol consumption as indicated by a score of 4 or more on the AUDIT-C
- Smoking and/ or chewing tobacco during the past 6 months
- Recreational drug use during the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Effect of Brahmi on Cognition Performance and Anxiety in Healthy Indian Adults and Exploration of Pharmacokinetic Properties of Brahmi Components in Healthy Adult Males.
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.
Read the 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.
- Conditions
- Cognition, Anxiety, Pharmacokinetics
- Being tested
- Brahmi, Placebo
- Keywords
- Brahmi, Cognition, Anxiety, Pharmacokinetics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrahmiDietary supplement
Also called Bacopa monniera
Brahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks.
PlaceboOther
Also called Dry Starch
Dry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks.
BrahmiDietary supplement
Also called Bacopa monniera
Brahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days.
PlaceboOther
Also called Maize Starch capsules
Placebo capsules - Dry starch filled in identical hard gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Brahmi - 36 subjects | Experimental | 36 subjects both male and female will consume 2 capsules of Brahmi for 84 days. Receives: Dietary Supplement: Brahmi |
| Placebo- 36 subjects | Placebo comparator | 36 subjects male and female who will take 2 capsules of placebo every day Receives: Other: Placebo |
| Brahmi - 8 Subjects | Experimental | For PK part of the study 8 male subjects will be taken for treatment arm. Each volunteer will consume 2 capsules of Brahmi each day for 84 days. Receives: Dietary Supplement: Brahmi |
| Placebo- 4 subjects | Placebo comparator | 4 male subjects in PK part will be in the placebo arm. Each volunteer will consume 2 capsules of Brahmi each day for 84 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delayed recall from Baseline at day 0 to post intervention at day 84
Rey Auditory Verbal Learning Test, Delayed recall
Measured: "0" (baseline) day and "84" day (Post Intervention)
Secondary outcomes (13)
Total learning, change between baseline at day 0 to post intervention at day 84
Rey Auditory Verbal Learning Test, total learning,
Measured: "0" day and "84" day
Pro-active interference, change between baseline at day 0 to post intervention at day 84
Rey Auditory Verbal Learning Test, pro-active interference
Measured: "0" day and "84" day
Retro-active interference, change between baseline at day 0 to post intervention at day 84
Rey Auditory Verbal Learning Test, retro-active interference
Measured: "0" day and "84" day
Inspection Time, change between baseline at day 0 to post intervention at day 84
Inspection Time Task: Inspection Time
Measured: "0" day and "84" day
Reaction time, correct responses, change between baseline at day 0 to post intervention at day 84
Rapid Visual Information Processing Test, reaction time, correct responses
Measured: "0" day and "84" day
Reaction time, errors, change between baseline at day 0 to post intervention at day 84
Rapid Visual Information Processing Test, reaction time, errors
Measured: "0" day and "84" day
Interference, change between baseline at day 0 to post intervention at day 84
Stroop Task, Interference
Measured: "0" day and "84" day
State, change between baseline at day 0 to post intervention at day 84
State-trait Anxiety Inventory, state
Measured: "0" day and "84" day
Trait, change between baseline at day 0 to post intervention at day 84
State-trait Anxiety Inventory, trait
Measured: "0" day and "84" day
Absorption constant
Constant of absorption of the Brahmi components
Measured: "0" day and "84" day
Tmax
Time of highest concentration in blood of the Brahmi components
Measured: "0" day and "84" day
T1/2
Half-life of the of the Brahmi components
Measured: "0" day and "84" day
Metabolites
Scan for potential metabolites of the Brahmi components
Measured: "0" day and "84" day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
- Responsible party
- Sponsor
- Investigators
- Krishnamachari Srinivasan, Principal investigator, St. John's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462642
- Sponsor's protocol ID
- 08068B
- Acronym
- Yaaddasht
- Status last verified
- Jun 2015
- First submitted
- 16 Sep 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of Brahmi on Cognition Performance and Anxiety in Healthy Indian Adults and Exploration of Pharmacokinetic Properties of Brahmi Components in Healthy Adult Males.
- ClinicalTrials.gov ID
- NCT02462642
- Acronym / sponsor ID
- Yaaddasht / 08068B
- Conditions
- Cognition, Anxiety, Pharmacokinetics
- Keywords
- Brahmi, Cognition, Anxiety, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brahmi - 36 subjects | Experimental | Dietary Supplement: Brahmi36 subjects both male and female will consume 2 capsules of Brahmi for 84 days. |
| Placebo- 36 subjects | Placebo comparator | Other: Placebo36 subjects male and female who will take 2 capsules of placebo every day |
| Brahmi - 8 Subjects | Experimental | Dietary Supplement: BrahmiFor PK part of the study 8 male subjects will be taken for treatment arm. Each volunteer will consume 2 capsules of Brahmi each day for 84 days. |
| Placebo- 4 subjects | Placebo comparator | Other: Placebo4 male subjects in PK part will be in the placebo arm. Each volunteer will consume 2 capsules of Brahmi each day for 84 days. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects in the age between 35 and 60 at start of the study
- BMI BETWEEN 20 and 30 kg/m2
- Apparently mentally and physically healthy
- Willing to refrain from foods and supplements that contain caffeine, such as coffee, tea, chocolate, cola and energy drinks from 9 PM on the evening before each test day.
- Willing to refrain from supplements that are likely to have an effect on cognitive performance
Key exclusion criteria (14 listed)
- Being on a medically prescribed- or slimming diet
- Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination
- Using herbal supplements or dietary supplements meant for improving cognitive performance
- Undergoing medical treatment that may interfere with the study outcome
- Using systemic antibiotics in the period of 3 months prior to or during the run-in period of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrahmiAlso: Bacopa monnieraBrahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks. | Dietary supplement | Brahmi - 36 subjects |
| PlaceboAlso: Dry StarchDry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks. | Other | Placebo- 36 subjects |
| BrahmiAlso: Bacopa monnieraBrahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days. | Dietary supplement | Brahmi - 8 Subjects |
| PlaceboAlso: Maize Starch capsulesPlacebo capsules - Dry starch filled in identical hard gelatin capsules | Other | Placebo- 4 subjects |
Primary outcome
Change in Delayed recall from Baseline at day 0 to post intervention at day 84
Time frame: "0" (baseline) day and "84" day (Post Intervention)
Rey Auditory Verbal Learning Test, Delayed recall
13 secondary outcomes
Total learning, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Pro-active interference, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Retro-active interference, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Inspection Time, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Reaction time, correct responses, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Reaction time, errors, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Interference, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
State, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Trait, change between baseline at day 0 to post intervention at day 84
Time frame: "0" day and "84" day
Absorption constant
Time frame: "0" day and "84" day
Tmax
Time frame: "0" day and "84" day
T1/2
Time frame: "0" day and "84" day
Metabolites
Time frame: "0" day and "84" day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishnamachari Srinivasan principal investigator
St. John's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brahmi in people with Cognition and Anxiety, run by Unilever R&D at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delayed recall from Baseline at day 0 to post intervention at day 84 (time frame: "0" (baseline) day and "84" day (Post Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.