None listed
Conditions
Interventions
Intervention1: RSF0020G: Oral administration of single dose of RSF00220G 250 mg capsule every night for 84 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo 250mg c
Sponsors
Akay Natural Ingredients Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with normal cognitive function. 2.Subjects with a MMSE Score >= 23. 3.Diabetes, hypertension and other medical condition patients should be on stable medication. for last 3 months 4.Non-smokers 5.Able to communicate verbally, able to write and speak English and comfortable with using computer. 6.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects with history of chronic diseases 2.Subjects who maybe allergic to any of the natural constituents of the Investigational Product. 3.Known HIV or Hepatitis B positive or any other immuno-compromised state. 4.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime. 5.Subjects visually or mentally handicapped or having difficulty to communicate 6.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 7.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in cognitive function evaluated by Neuropsychological assessmentTimepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in BiomarkersTimepoint: Day 0, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bioservices Pvt. Ltd
Outcome results
None listed