Health Condition 1: F068- Other specified mental disorders due to known physiological condition
Conditions
Interventions
Intervention1: Berberis aristata capsule containing NLT 30 mg Berberine: Berberis aristata is a Scarlet red colored capsules containing yellowish brown and white colored granules of roots of plant Ber
Sponsors
Omniactive Health Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male/female human participants of = 18 and =55 years of age. 2.Participants with BMI = 18.5 kg/m2 and = 29.9 kg/m2. 3.Participants with Mini-Mental State Examination (MMSE) score 19 to 26 indicating mild cognitive impairment. 4.Participants who agree to maintain their usual dietary habits throughout the trial period. 5.Participants who agree to maintain their usual level of activity, i.e., maintain their usual lifestyle throughout the trial period.
Exclusion criteria
Exclusion criteria: 1.Participants ? 18 or ? 55 years of age. 2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients. 3.Participants suffering from moderate to severe fatigue or having chronic fatigue syndrome. 4.Participants suffering from malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. 5.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in memory functions as assessed by Working memory - Monkey Ladder task, Episodic memory - Paired Associates task, Short-term spatial memory - Spatial Span task and Short-term verbal memory - Digit Span task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 + 3 days)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in planning as assessed by Spatial Planning task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days) 2.Mean change in reasoning and decision making as assessed by Odd One Out task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days)Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDivya C
Bioagile Therapeutics Pvt. Ltd
Outcome results
None listed