A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of B-Lit Bacopa on Stress and Sleep in Subjects with Non-Chronic Stress
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change on stress using Perceived Stress Scale assessed for B-Lit Bacopa compared to placebo
研究概览
简要总结
This is a double blind, placebo-controlled, randomized clinical trial. Adult subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms (1:1) to receive either B-Lit Bacopa or Placebo for 12 weeks. Clinical assessments shall include all the measures required for the primary and secondary objectives. The total study duration for the clinical part shall be a maximum of 90 days which includes 5 days of screening period, randomization 1 day and supplementation period of 84 days and end of study visit at 84 days. Subjects will visit the study site on 6 different occasions during the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •Participants who have received any experimental medicine or device within 3 months preceding trial enrolment.
结局指标
主要结局
Mean change on stress using Perceived Stress Scale assessed for B-Lit Bacopa compared to placebo
时间窗: Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84
次要结局
- Mean change in Biomarkers(Baseline and Day 84)
- Mean change in Sleep assessment parameters(Day 0 and Day 84)
- Mean change in questionnaire based assessments(Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84)