None listed
Conditions
Interventions
Intervention1: Low molecular weight chondroitin sulfate LMW CS: Dose: 300mg capsule containing 100 mg of Low molecular weight chondroitin sulfate sodium Dosage form: Capsules Route of administration:
Sponsors
DAEHAN CHEMTECH CO., LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 50-70 years. 2. Subjects who self-report mild cognitive decline. 3. Subjects with Hindi Mental State Examination HMSE score between 20 and 26.
Exclusion criteria
Exclusion criteria: 1. Subjects with a diagnosis of dementia as per the Diagnostic and Statistical Manual of Mental Disorders DSM 5. 2. Subjects with a diagnosis of attention deficit hyperactivity disorder ADHD as per the Diagnostic and Statistical Manual of Mental Disorders DSM 5. 3. Subjects who are currently undergoing structured exercise therapy or dietary therapy. 4. Subjects with cognitive impairment due to organic brain disease or mental or psychiatric illness. 5. Subjects with a Hospital Anxiety and Depression Scale HADS depression subscale score greater than 7. 6. Subjects with a Hospital Anxiety and Depression Scale HADS anxiety subscale score greater than 7. 7. Subjects with an Insomnia Severity Index ISI score greater than 7. 8. Subjects with an Alcohol Use Disorders Identification Test AUDIT score greater than 3. 9. Subjects with a history of antipsychotic medication use within the 3 months preceding the screening visit. 10. Subjects who are currently on or were in the past 4 weeks preceding the screening visit on any medications that could impair cognitive function, including anticholinergic medications diphenhydramine, atropine, benzodiazepines alprazolam, lorazepam, diazepam, antiepileptic drugs topiramate, levetiracetam, phenytoin, antihypertensive medications mlodipine, beta blockers, diuretics, opioids codeine, oxycodone, hydrocodone, antihistamines diphenhydramine, chlorpheniramine, cetirizine, and tricyclic antidepressants amitriptyline, imipramine, nortriptyline. 11. Subjects who have received treatment with any approved or investigational health supplements for improvement of cognition and memory within the past 1 month preceding the screening visit. 12. Subjects with a history of traumatic brain injury with loss of consciousness or convulsion. 13. Subjects with uncontrolled blood pressure, diabetes mellitus, or hypothyroidism. 14. Subjects with abnormal laboratory findings such as AST or ALT greater than 3 times the upper limit of normal, Hb less than or equal to 8 g per dL, platelet count less than 100000 per mm3, or TSH less than or equal to 0.1 microIU per mL or greater than or equal to 10 microIU per mL. 15. Subjects with serum creatinine greater than 3 times the upper limit of normal or with acute or chronic renal failure requiring dialysis. 16. Subjects participating in another clinical trial within the 3 months preceding the screening visit. 17. Subjects with severe hearing or vision impairment that prevents efficacy evaluation. 18. Subjects with any neurological, congenital or acquired, vascular, or systemic disorder that could affect the efficacy assessments. 19. Subjects with any clinically significant disease that, in the investigators opinion, may substantially affect the subjects overall well being, including cardiovascular, endocrine, immune, respiratory, renal, urinary, neuropsychiatric, musculoskeletal, inflammatory, hematological, or gastrointestinal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the total and subscores of the Alzheimers Disease Assessment Scale Cognitive Subscale ADAS CogTimepoint: Baseline, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the scores of the Digit Span Memory Test. 2. Change in the total and subscores of the Montreal Cognitive Assessment MoCA TestTimepoint: Baseline, Day 45, Day 90;1. Change in the total and subscores of the Hindi Mental State Examination HMSE. 2. Change in serum Brain-Derived Neurotrophic Factor BDNF. 3. Change in serum Malondialdehyde MDA 4. Change in serum Superoxide Dismutase SOD score 5. Change in serum Glutathione levels. 6. Change in serum TNF alpha levels. 7. Change in serum IL 6 levels Safety Basic hematology, biochemistry and urinalysis parameters.Timepoint: Baseline and Day 90 | — |
Countries
India
Contacts
Public ContactDR. SWAPNA BONDADE
Bangalore Clinical Services
Outcome results
None listed