A Study to Evaluate the Safety and Efficacy of B-Lit Bacopa on Stress and Sleep in Subjects with Non-Chronic Stress

Not yet recruiting

Conditions: Other sleep disorders,

Registration Number: CTRI/2025/05/087114

Lead Sponsor: Samriddh Nutractive Pvt. Ltd.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change on stress using Perceived Stress Scale assessed for B-Lit Bacopa compared to placebo	Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): BGS Global Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Shashank S Gowda
Principal investigator
9741073960
drshashank.research@gmail.com