None listed
Conditions
Interventions
Intervention1: SOBC-730 350 mg: Take 1 capsule once daily in the morning for 8 weeks
Control Intervention1: Placebo: Take 1 capsule once daily in the morning for 8 weeks
Sponsors
Arjuna Natural Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participant aged 18 to 65 years at the time of screening 2. Montreal Cognitive Assessment (MoCA) score between 22 and 26, inclusive, at screening 3. Subjective distractibility without ADHD diagnosis 4. Education level : over high school 5. Subjective complaints of memory difficulty, distractibility, or reduced cognitive performance without a diagnosis of dementia 6. Ability to understand and complete digital or paper-based cognitive assessments 7. Willingness to maintain usual lifestyle habits and refrain from initiating new cognitiveenhancing supplements or medications during the study 8. Ability and willingness to comply with all trial procedures and visit schedules 9. Provision of written informed consent prior to any trial-specific procedures
Exclusion criteria
Exclusion criteria: 1. Diagnosis of dementia, Alzheimer s disease, or other major neurocognitive disorder 2. History of significant neurological conditions, including but not limited to stroke, epilepsy, traumatic brain injury, brain tumor, or neurodegenerative disease 3. Severe psychiatric disorders, including major depressive disorder, schizophrenia, bipolar disorder, alcohol dependence, or substance abuse 4. Use of medications that may interfere with cognitive outcomes within 4 weeks prior to screening, including: Dementia treatment drugs, Thyroid hormone drugs, Central nervous system stimulants, Antipsychotics, Anticholinergic drugs, Brain metabolism enhancers 5. Diagnosed sleep disorders that may significantly affect cognitive function 6. Uncontrolled endocrine disorders, including uncontrolled diabetes or abnormal thyroid function 7. Clinically significant abnormal laboratory values at screening, including ALT or AST greater than 3 times upper limit of normal, Hb less than or equal to 8 g per dL or platelet count less than 100,000 per mm , eGFR less than 60 mL/min/1.73 m 8. Uncontrolled hypertension (SBP greater than 140 mmHg or DBP greater than 90 mmHg) 9. Thyroid-stimulating hormone (TSH) levels outside the normal range for the institution. 10. Unstable angina, myocardial infarction, transient ischemic attack, or coronary interventions including coronary artery bypass surgery within 6 months prior to the consent date. 11. Severe trauma with loss of consciousness within 6 months prior to the consent date. 12. Acute stroke within 3 months prior to the consent date 13. Shift workers 14. Alcohol consumption exceeding WHO s daily intake guidelines greater than or equal to 40 g/day for men and greater than or equal to 20 g/day for women. 15. Heavy smokers (greater than or equal to 20 cigarettes/day) 16. Heavy use greater than 300 mg/day (greater than or equal to 3 cups coffee, energy drinks) 17. Pregnant, lactating, or planning pregnancy during the study period 18. Known hypersensitivity to any component of the investigational product 19. Participation in another clinical trial within 3 months prior to screening 20. Any medical condition or circumstance that, in the opinion of the Investigator, could interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of the investigational herbal product on memory function compared with placebo, as assessed by validated cognitive assessment tools.Timepoint: Baseline, Week 4, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of the investigational product on attention, executive function, and working memory.Timepoint: Baseline, Week 4, Week 8;To evaluate changes in neuroendocrine biomarkers associated with cognitive functionTimepoint: Baseline, Week 8;To assess the safety and tolerability of the investigational product over the study durationTimepoint: Throughout the study duration | — |
Countries
India
Contacts
Public ContactDr Giby Abraham
Arjuna Natural Private Limited
Outcome results
None listed