Health Condition 1: G478- Other sleep disorders
Conditions
Interventions
Intervention1: B-Lit Bacopa: Single capsule of B-Lit Bacopa once a day for 84 days
Control Intervention1: Placebo: Single capsule of Placebo once a day for 84 days
Sponsors
Samriddh Nutractive Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.BMI of 18.5 kg per meter square to 29.9 kg per meter square.2.Non-chronic stress of not more than 12 weeks at the time of screening.3.Mild to moderate levels of stress on PSS score greater or equal to 10 and lesser or equal to 26.4.No reported history of psychological or mental disorders.5.Willing and able to give informed consent.6.Willing to stop use of other herbal supplements, over-the-counter medications, or prescriptions during the study.7.Avoid the consumption of any medications or preparations that are intended to alleviate tension, anxiety, or mood during the course of the study.8.Refrain from consuming alcohol 24 hours prior to the study visit days.9.Refrain from vigorous physical activity 12 hours prior to study visit days.10.Refrain from consuming caffeine and caffeine-containing products 12 hour prior to study visit days.11.Agree to maintain the usual lifestyle throughout the study period.12.Female subjects of childbearing potential practicing an acceptable method of birth control.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity or history of allergy to the study product.2.History of cardiovascular disease, neurological disorders, gastrointestinal disorders, kidney or liver disease, uncontrolled metabolic disorders that could affect the study outcomes.3.Malignant disease or any concomitant end-state organ disease.4.Psychiatric diagnosis including anxiety or depression.5.Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening.6.Participants with a history of drug and or alcohol abuse at the time of enrolment.7.Participants who are pregnant, breastfeeding, or intending to conceive during the study period.8.Participants with positive Urine Pregnancy Test at screening or randomization visit.9. Participants who have received any experimental medicine or device within 3 months preceding trial enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change on stress using Perceived Stress Scale assessed for B-Lit Bacopa compared to placeboTimepoint: Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Sleep assessment parametersTimepoint: Day 0 and Day 84;Mean change in questionnaire based assessmentsTimepoint: Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84;Mean change in BiomarkersTimepoint: Baseline and Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed