A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of RSF0020G on management of cognitive functions in Healthy Subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Mean change in cognitive function evaluated by Neuropsychological assessment
Study Overview
Brief Summary
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects aged 35-60 years with normal cognition assessed by Mini-Mental State Examination (MMSE) and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms to receive RSF0020G or placebo in 50:50 ratio. The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments. Post blood sample collection, the subjects will undergo various assessments to evaluate their cognitive functions. The subjects will visit the site on 4 different occasions during the 12-week study duration.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects with normal cognitive function.
- •2.Subjects with a MMSE Score ≥
- •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
- •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.
Outcomes
Primary Outcomes
Mean change in cognitive function evaluated by Neuropsychological assessment
Time Frame: Day 0, Day 42, Day 84
Secondary Outcomes
- Changes in Biomarkers(Day 0, Day 84)