None listed
Conditions
Interventions
Intervention1: NGGSCOG Tablet (525 mg): 1. Bacopa monnieri (50% bacosides)- 275 mg
2.L-Tyrosine- 75 mg
3. Ginkgo biloba extract 24% -120 mg
4. L-Citrulline -30 mg
Excipients
5. Ethyl Cellulose- 1
Sponsors
Hirehal Greenspace Herbs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female, aged 18 65 years. 2. 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. 3. Functionally independent, living in the community, and able to perform daily activities without assistance. 4. Good general health without evidence of pathological cognitive decline or neurological disease. 5. No history of cardiac or cerebrovascular ischemic events within the last 12 months. 6. Ability to read, write, and understand the study assessments and questionnaires. 7. 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). 8. 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. 9. Willing and able to comply with study procedures, including scheduled visits and cognitive testing. 10. Voluntarily sign informed consent form prior to participation.
Exclusion criteria
Exclusion criteria: 1. Known allergies or hypersensitivity to any ingredient of the study products. 2. History or current diagnosis of neurocognitive disorder (e.g., dementia, Alzheimer s disease, mild cognitive impairment with clinical diagnosis). 3. Current Severe Depressive Episode, bipolar disorder, schizophrenia, or other severe psychiatric illnesses that could affect cognition. 4. Participants with moderate or higher depressive symptoms on DASS-21 Depression. 5. History of stroke, Parkinson s disease, multiple sclerosis, epilepsy, traumatic brain injury, or other neurodegenerative disorders. 6. Participants with high caffeine consumption (greater than 100 mg/day). 7. Current smokers or recent history of smoking in the past 6 months. 8. Alcohol or substance use disorder (recent or uncontrolled). 9. 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. 10. Pathological cognitive decline confirmed by medical evaluation. 11. History of malignancy within the last 12 months. 12. Severe uncontrolled cardiovascular, hepatic, renal, or metabolic disorders that could interfere with cognitive function or study participation. 13. Undergoing any treatment known to interfere with the study product or outcomes. 14. Current use of cognitive enhancers or other investigational drugs within the last 3 months. 15. Current use of immunosuppressant medications. 16. Participants participated in another clinical trial within 6 months. 17. Inability to read, write, or comprehend language sufficient to complete study questionnaires and cognitive tests. 18. Any condition that, in the opinion of the investigator, may interfere with study participation, cognitive assessments, or pose undue risk to the participant. 19. Pregnant or breastfeeding women, or women planning pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cognitive function domains measured from baseline to end of study using: Mental Speed: Digit Symbol Substitution Test Focused Attention: Colour Trails Test Sustained Attention: Digit Vigilance Test Divided Attention: Triads Test Working Memory: Verbal N-Back Test Response Inhibition: Stroop Test Learning & Memory (Verbal): Auditory Verbal Learning Test (AVLT) Learning & Memory (Visuo-Spatial Construction): Complex Figure TestTimepoint: Baseline, week 6 and week 12 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in emotional states from baseline to week 6 and end of study using Depression Anxiety Stress Scale-21 (DASS-21). 2) Improvement in Quality of life from baseline to end of study assessed using SF-36 Questionnaire. 3) Assessment of adverse events, vital signs, Complete blood count (CBC), liver function test (LFT) and kidney function test (RFT) (Baseline and End of Study).Timepoint: Baseline, week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactMeena Dalal
Maayra Emotional Wellness Centre
Outcome results
None listed