2.4.4. Intervention.
ADVERSE EVENTS
The study participants were instructed to consume ARE-500 mg, with 95% piperine-5 mg, (Total wt. 505 mg) or a comparable placebo containing microcrystalline cellulose (505 mg) per capsule once a day at bedtime for 60 days. Both the capsules were identical in appearance and weight.The study period consisted of 4 scheduled visits, including a screening visit, a baseline visit (day 0), and 2 follow-up visits. The PSS and GAD-7 scores were assessed on screening visits as part of the inclusion criteria and on days 30 and 60. The general health condition of the participants, vital parameters, demographic details, and laboratory tests including hematological, biochemical, and urinary parameters, were evaluated on the screening day and days 30 and 60. The baseline visit was within 6 days of the screening for eligible candidates. During this visit and on day 60, the quality-of-life questionnaire, the Cambridge Neuropsychological Test Automated Battery (CANTAB) analysis, salivary cortisol, urinary dopamine, serotonin, and antioxidant markers were carried out. The schedule of enrollment, interventions, and assessments are provided in the Supplementary Table S1, Additionally, a telephonic follow-up was conducted after 15 days from the date of the last visit to assess the occurrence of any adverse events (AEs) and overall well-being. Compliance was assessed by recording the number of capsules dispensed and consumed by the subject and those returned at each visit, in the case record form.