To Access the Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour.

NCT03198936 | Completed

• 1 other identifier: LM/161103/BP/MCI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.

Conditions

Memory Dysfunction; Mood Disorders

Outcome Measures

Primary Outcomes (1)

• Working Memory Capacity

  To evaluate effect of Brain Pill™ on working memory capacity as improvement in mean response time and accuracy and measured by working memory battery.

  84 days

Secondary Outcomes (2)

• Attention and Concentration

  84 days

• Improvement in Mood Disturbances

  84 days

Study Arms (2)

Cognizin® SynapsaTM

EXPERIMENTAL

Dose - 2 capsules twice a day with meals

Dietary Supplement: Cognizin® SynapsaTM

Placebo

PLACEBO COMPARATOR

Matching placebo capsules with microcrystalline cellulose with added colours Dose - 2 capsules twice a day with meals

Dietary Supplement: Placebo

Interventions

Cognizin® SynapsaTM DIETARY_SUPPLEMENT

2 capsules to be taken twice a day with meals with a glassful of water

Cognizin® SynapsaTM

Placebo DIETARY_SUPPLEMENT

2 capsules to be taken twice a day with meals with glassful of water

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with Mini-Mental State Examination (MMSE) score \> 23 indicating a healthy cognitive state.
• Subjects with Adult Memory Questionnaire (AMQ) score of 40-70% indicating subjective memory lapse.
• Subjects with T score on 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form: 50.0-59.9 (mild) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) criteria.
• Males and Females of Age 18 - 60 years will be selected for the study.
• Subject who is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
• Subject who has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
• Subject should be willing to refrain from consuming alcohol 24 h prior to the test days.
• Subject should be willing to refrain from consuming caffeine and caffeine-containing products 12 h prior to test days.
• Subject should be willing to refrain from vigorous physical activity 12 h prior to test days.
• Subject should be a non-smoker.
• Subject who understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

• Subjects with MMSE score ≤ 23 indicative of clinical dementia.
• Subjects with AMQ score \<40 and \>70 %.
• T score on 8-item PROMIS Depression Short Form \<50 (normal) and ≥60 (moderate and severe).
• Confirmed diagnosis of dementia/ Alzheimer's disease.
• Current evidence of hearing impairment or other information processing impairment.
• Subjects who are using amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants, as disclosed at the screening visit.
• Subjects with uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at the screening.
• Subjects with a history or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
• Subject with a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study or which could significantly influence cognitive abilities.
• Use of any sleep aid medication.
• Pregnant female subjects or planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
• Excessive habitual caffeine consumption (\>300 mg caffeine/d or ≥3 cups of caffeinated coffee/d), following screening and throughout the study period.
• Use of any psychotropic medication within four weeks of screening and throughout the study.
• Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
• Subject who has had exposure to any non-registered drug product within 30 days prior to the screening visit.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead
• Leading Edge Marketing LTD.: collaborator

Study Sites (1)

Vedic Lifesciences Pvt.Ltd

Mumbai, Maharashtra, 400053, India

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Divya Patel, BSc

  Affiliated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: June 26, 2017
• Study Start: April 11, 2017
• Primary Completion: November 17, 2017
• Study Completion: March 15, 2018
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)