None listed
Conditions
Interventions
Intervention1: XanMax2002 (Lutein and Zeaxanthin 20 mg (in the ratio of 10:1): Dosage Form : Capsule
Dose: 20 mg
Route of administration : Orally
Frequency: One capsule orally in the morning before
Sponsors
Katra Phytochem (India) Private Limited
Daehan Chemtech co LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult male and female subjects aged between 50-70 years old complaining of memory impairment. 2 Subjects with a Hindi Mental State Examination (HMSE) score between 20 to 26. 3 Must be willing and able to give informed consent and comply with the study procedures
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 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 of greater than7. 6 Subjects with a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than7. 7 Subjects with an Insomnia Severity Index (ISI) score of greater than 7. 8 Subjects with an Alcohol Use Disorders Identification Test (AUDIT) score of 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 which could impair cognitive functions such as anticholinergic medications (diphenhydramine, atropine); benzodiazepines (alprazolam, lorazepam, and diazepam); antipsychotic medications (risperidone, olanzapine, and quetiapine); antiepileptic drugs (topiramate, levetiracetam, and phenytoin); antihypertensive medications (amlodipine, beta-blockers, and diuretics); opioids (codeine, oxycodone, and hydrocodone); antihistamines (diphenhydramine, chlorpheniramine, and cetirizine); nortriptyline). 11 Subjects who have received treatment with any approved or investigational health supplement(s) for improvement of cognition and memory within the past 1 month preceding the screening visit. 12 Subjects whose neuropsychological tests indicate a suspected diagnosis of dementia. 13 Subjects with a history of any traumatic brain injury with loss of consciousness or convulsion. 14 Subjects with uncontrolled blood pressure, diabetes mellitus, or hypothyroidism. 15 Subjects with abnormal laboratory test findings such as: AST and ALT greater than 3 times the upper limit of normal Hb less than or equal to 8 g/dL Platelet count lessthan100000/mm3 16 Subjects with serum creatine greater than 3 times the upper limit of normal or with acute or chronic renal failure requiring dialysis. 17 Subjects participating in another clinical trial within the 3 months preceding the screening visit. 18 Subjects with severe hearing and vision impairment for whom efficacy evaluation cannot be conducted. 19 Subjects with any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments. 20 Subjects with any underlying clinically significant disease that, in the view of the investigator, will substantially impact the subjectâ??s overall well-being including conditions affecting the cardiovascular, endocrine, immune, respiratory, kidney and urinary, neuropsychiatric, musculoskeletal, inflammatory, blood, as well as gastrointestinal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the scores of the Wechsler Memory Scale-III (WMS-III) from Baseline to Day 84 and 168.Timepoint: Base line to Day 84 and Day 168. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the scores of the Hindi Mental State Examination (HMSE) from Baseline to Day 168 2. Change in the scores of the ADAS-Cog from Baseline to Day 168. 3. Change in serum Brain-Derived Neurotrophic Factor (BDNF) from Baseline to Day 168. 4. Change in serum Beta -Amyloid from baseline to Day 168. 5. Change in serum Reactive Oxygen Species (ROS) from baseline to Day 168. 6. Change in serum Superoxide Dismutase (SOD) score from baseline to Day 168. 7. Change in serum Glutathione levels from baseline to Day 168. 8. Change in serum Glutathione Peroxidase (GPx) levels from baseline to Day 168. 9. Change in serum Catalase (CAT) levels from baseline to Day 168. Timepoint: Base line (Day 0) to End of the study (Day168).;Safety Endpoints 1. Adverse events (AEs). 2. Abnormal findings in vital signs and medical interviews. 3. Abnormal changes in the hematology / blood chemistry / urinalysis test results Timepoint: Base line (Day 0) to End of the study (Day168). | — |
Countries
India
Contacts
Public ContactMs Priya
Katra Phytochem (India) Pvt Ltd
Outcome results
None listed