Stress is the body's physiological response to mental or physical threats. It is often accompanied by anxiety, defined as an unpleasant emotion triggered by anticipation of future events and memories of past events. Exposure to stress and anxiety can cause psychological distress and impaired sleep quality. Stress and anxiety are characterised by a condition of sympathetic hypertonia that can alter blood pressure. The combination of these factors impairs quality of life and performance in daily life. This prospective cohort, noncomparative, multicenter clinical study is part of the search for a nutraceutical that can help meet the need to reduce the perception of stress and anxiety, improve psychological well-being and sleep quality, and help regulate blood pressure to mitigate the effect of these prevalent health risks and reduce the use of drugs, the chronic use of which can expose people to additional health risks. 48 physicians distributed throughout Italy included 503 patients (151 men, 352 women) with a mean age of 50.4 years ± 14.3 years in the study. Patients presented to the physician's observation with anxiety, stress, and anxiety-related sleep disturbances and scored a mean score on the Perceived Stress Scale (PSS) questionnaire of 24.3 ± 5.1 and a mean score on the World Health Organisation 5-question Well-Being Questionnaire (WHO-5) of 8.0 ± 3.2. The enrolled patients were evaluated at the time of enrolment (T0) and 45 days after enrolment (T1). From the day of enrolment and for 45 days after that, they took one tablet of a nutraceutical containing Withania somnifera, Crataegus monogyna, magnesium and vitamin B6 in the morning and one in the evening, half an hour before bedtime. At enrolment (T0), patients completed WHO-5, PSS and a Sleep Quality rating Scale (SQS), while the investigating physicians, together with the patients, completed the Hamilton Anxiety Rating Scale and blood pressure measurements. At T1, the questionnaires and SQS were repeated, blood pressure was measured, and the patients rated their satisfaction with the therapy. The scores on all questionnaires and the SQS improved significantly at T1 compared to T0, and there was also a significant adjustment in blood pressure with higher values being lowered and lower values being raised. The results of the study show that the tested nutraceutical, taken in the amount of one tablet twice a day, reduces the perception of stress and anxiety, improves sleep quality and psychological well-being and helps regulate blood pressure in stressed and anxious subjects. Finally, the product has been confirmed as safe and appreciated: only one patient discontinued treatment because of the nausea sensation he attributed to taking the product.
