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.