Background center dot The demand for "energy healing" is growing rapidly in the United States and other developed countries. To date, scanty clinical trials have been conducted to evaluate its clinical safety, efficacy, and cost-effectiveness. Primary Study Objective center dot The study aimed to investigate the safety and efficacy of the Blessed TRI 360 (TM) capsule (Biofield Energy Treated Proprietary Dietary Supplement Capsules Powered by the Trivedi Effect((R))). Methods/Design center dot A total of 77 adult subjects (male and female) aged 20-45 years with one or more psychological symptoms were enrolled in the trial. The subjects were randomized into two groups: placebo control and treatment group. The treatment group (n = 35) received the Blessed TRI 360 (TM) capsule twice a day, once in the morning and once in the evening. The placebo control group (n = 42) did not receive any treatment/capsule. Setting center dot An open-label, single-center, randomized controlled trial (RCT). Participants center dot Adult human subjects (male and female) with one or more psychological symptoms. Intervention center dot Biofield energy treated proprietary capsule. Primary Outcome Measures center dot Psychological questionnaire scores and functional physiological biomarkers. Results center dot Psychological and mental health symptoms were statistically and significantly reduced in the subjects taking the Blessed TRI 360TM capsule compared to the placebo group on both days 90 and 180. Furthermore, levels of functional physiological biomarkers were higher in the intervention group compared to the placebo group: vitamins (C, B-12, and D-3 active metabolites), neurotransmitters (acetylcholine, noradrenaline, and dopamine), hormones (17-beta-estradiol, oxytocin, and insulin), antioxidant enzyme (catalase), and anti-aging protein (klotho). Additionally, proinflammatory cytokines (TNF-alpha, IL-1 beta, IL-8, IFN-gamma, and IL-2), progesterone, and oxidative stress markers (MDA and oxidized-LDL) were lower in the Blessed TRI 360TM group than the placebo group after the intervention. Conclusions center dot Altogether, the Blessed TRI 360TM dietary supplement capsule was found to be safe and tolerable. It significantly improved psychological symptoms and mental disorders and simultaneously improved different functional physiological biomarkers that led to an improvement in the overall health and quality of life of the adult subjects. Clinical Trial Registration Number center dot ECR/147/ Inst/ GJ/2013/RR-16.
