A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Cognitive Enhancement Supplement in Healthy Adults with Mild Cognitive Complaints
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Hirehal Greenspace Herbs Private Limited
- Enrollment
- 100
Overview
Brief Summary
This clinical research project is designed to evaluate the effectiveness and safety of a nutraceutical formulation, NGGSCOG, developed by Hirehal Greenspace Herbs Private Limited, in improving cognitive performance in healthy adults who experience self-reported mild cognitive complaints. These complaints may include reduced attention span, poor concentration, slow mental processing, or difficulty recalling information, often associated with factors such as stress, heavy workload, academic pressure, or demanding professional environments. Importantly, participants do not have any diagnosed neurological or neurocognitive disorders, making this a study focused on cognitive wellness and enhancement rather than disease treatment. The trial follows a randomized, double-blind, placebo-controlled, parallel-group design, which is considered the gold standard for minimizing bias and ensuring reliable clinical evidence. A total of 100 eligible participants aged 18–65 years will be enrolled after screening and informed consent. They will be randomly assigned in a 1:1 ratio to receive either NGGSCOG or a matching placebo, administered orally once daily for 12 weeks. Randomization is generated using a computer-based schedule, and both products are provided as identical capsules, ensuring full blinding of participants, investigators, and outcome assessors. The primary objective of the study is to determine whether NGGSCOG can improve key cognitive domains, including memory, attention, working memory, mental speed, information processing, and response inhibition. These functions will be measured using a standardized set of neuropsychological tests from the NIMHANS battery. The secondary objectives are to assess whether the product has additional benefits on emotional well-being—specifically stress, anxiety, and depression—using the DASS-21 scale, and to evaluate improvements in overall quality of life using the SF-36 questionnaire. Safety will be monitored throughout the study through adverse event reporting, vital signs, and laboratory investigations such as CBC, liver function tests, and kidney function tests. The trial also includes an exploratory objective: to examine changes in serum Brain-Derived Neurotrophic Factor (BDNF) levels from baseline to Week 12. BDNF is a biomarker associated with neuroplasticity, learning, and memory, offering insight into the potential biological mechanisms underlying cognitive enhancement. Participants will complete three visits: a Screening/Baseline visit, a Week 6 follow-up, and an End-of-Study visit at Week 12, during which all assessments are repeated. Compliance is monitored throughout the study, and participants who complete all procedures will be included in the final analysis. Overall, this project aims to generate high-quality clinical evidence on whether NGGSCOG, a nutraceutical cognitive support product, can safely and effectively enhance cognitive performance and emotional well-being in healthy adults who experience everyday cognitive challenges. The findings may support the development of evidence-based nutraceutical solutions for cognitive health and wellness.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult male or female, aged 18–65 years.
- •Self-reported mild cognitive complaints such as reduced attention span, poor concentration, or ineffective recall associated with stress, academic pressure, or high workload, without any clinically diagnosed neurocognitive disorder.
- •Participants should have cognitively demanding lifestyles such as students, working professionals, researchers or e-gamers.
- •Functionally independent, living in the community, and able to perform daily activities without assistance.
- •Good general health without evidence of pathological cognitive decline or neurological disease.
- •No history of cardiac or cerebrovascular ischemic events within the last 12 months.
- •Ability to read, write, and understand the study assessments and questionnaires.
- •Willingness to refrain from consuming any other cognitive or protein supplements during the study period (including energy drinks, gums, or protein supplements containing caffeine or other stimulants).
- •Moderate caffeine intake (less than equal to 100 mg/day) and low-to-moderate alcohol consumption (less than equal to 2 standard drinks/week) are permitted, provided that the intake remains consistent throughout the study period.
- •Willing and able to comply with study procedures, including scheduled visits and cognitive testing.
Exclusion Criteria
- •Known allergies or hypersensitivity to any ingredient of the study products.
- •History or current diagnosis of neurocognitive disorder (e.g., dementia, Alzheimer’s disease, mild cognitive impairment with clinical diagnosis).
- •Current Severe Depressive Episode, bipolar disorder, schizophrenia, or other severe psychiatric illnesses that could affect cognition.
- •Participants with moderate or higher depressive symptoms on DASS-21 Depression.
- •History of stroke, Parkinson’s disease, multiple sclerosis, epilepsy, traumatic brain injury, or other neurodegenerative disorders.
- •Participants with high caffeine consumption (greater than 100 mg/day).
- •Current smokers or recent history of smoking in the past 6 months.
- •Alcohol or substance use disorder (recent or uncontrolled).
- •Individuals with a history or evidence of binge drinking or those with high alcohol consumption (more than 2 standard drinks per week) will be excluded.
- •Pathological cognitive decline confirmed by medical evaluation.
Investigators
Dr Ajith Partha
Maayra Emotional Wellness Centre