None listed
Conditions
Interventions
Intervention1: Bacopa monnieri extract: A single dose of 400 mg capsules containing 300 mg Bacopa monnieri extract once for 84 days
Control Intervention1: Placebo: A single dose of 400 mg Placebo cap
Sponsors
Samriddh Nutractive Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 2.Refrain from taking any medications to improve memory and cognition during the study. 3.Healthy subjects with MMSE score of 24-30. 4.Willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visiting days. 5.Willing to refrain from consuming alcohol 24 hours prior to the visiting days. 6.Willing to refrain from vigorous physical activity 12 hours prior to test days. 7.Having basic computer literacy and exposure to computerized tests. 8.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Consumption of any memory improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines. 2.Subjects having hypersensitivity or history of allergy to the study product. 3.Subjects with any degree of cognitive impairment. 4.Subjects with sleep disturbances and/or are taking sleep aid medication. 5.Subjects with chronic diseases like hypertension, ischemic heart disease, diabetes, and psychiatric or CNS disorders. 6.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. 7.Excessive habitual caffeine consumption ( >300 mg caffeine/day or =3 cups of caffeinated coffee/day) throughout the study period. 8.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 9.Positive Urine Pregnancy Test at Screening /Randomization Visit. 10.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 11.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in memory skills parametersTimepoint: Baseline, Day 14, Day 28, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in biomarkersTimepoint: Baseline, Day 84;Safety of the study productsTimepoint: Baseline, , Day 14, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed