To Access the Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour.
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|ClinicalTrials.gov Identifier: NCT03198936|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Memory Dysfunction Mood Disorders||Dietary Supplement: Brain Pill Dietary Supplement: Placebo||Not Applicable|
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement with a balanced composition of scientifically proven nutrients for accelerating and restoring brain function and thereby enhancing the cognitive performance and creating positive impact on behavioral outcomes.Hence the aim of the study is assessment of the effects of Brain Pill supplementation on memory performance in healthy adults with subjective memory complaints.
It is a double-blind, randomized, placebo-controlled , single centered study to access the efficacy of Brain Pill on working memory capacity and mild mood disturbances.
Effect of Brain Pill on working memory capacity will be accessed by improvement in mean response time and accuracy measured by working memory battery from baseline to end of the study. Effect of Brain Pill is also accessed on Neurophysiological improvement in working memory as measured by electroencephelogram (EEG) from baseline to end of the study. Also improvement in attention and concentration will be accessed from baseline to end of the study by Picture recognition test.
Effect of Brain Pill on mood disturbances will be accessed by Brunel Universal Mood State.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double Blind|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour in Healthy Adults With Subjective Memory Complains and Mild Mood Disturbances.|
|Actual Study Start Date :||April 11, 2017|
|Actual Primary Completion Date :||November 17, 2017|
|Actual Study Completion Date :||March 15, 2018|
Experimental: Brain Pill
Dose - 2 capsules twice a day with meals
Dietary Supplement: Brain Pill
2 capsules to be taken twice a day with meals with a glassful of water
Placebo Comparator: Placebo
Matching placebo capsules with microcrystalline cellulose with added colours Dose - 2 capsules twice a day with meals
Dietary Supplement: Placebo
2 capsules to be taken twice a day with meals with glassful of water
- Working Memory Capacity [ Time Frame: 84 days ]To evaluate effect of Brain Pill™ on working memory capacity as improvement in mean response time and accuracy and measured by working memory battery.
- Attention and Concentration [ Time Frame: 84 days ]To evaluate effect of Brain Pill™ on attention and concentration as measured by Picture recognition test (PRT).
- Improvement in Mood Disturbances [ Time Frame: 84 days ]To evaluate effect of Brain Pill™ on mood disturbances as measured by Brunel Universal Mood States (BRUMS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198936
|Vedic Lifesciences Pvt.Ltd|
|Mumbai, Maharashtra, India, 400053|
|Study Chair:||Divya Patel, BSc||Affiliated|