Study protocol of a randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of an Ayurveda formulation (Ayush-SR) in the management of occupational stress among nurses

Abstract

Abstract BACKGROUND: Work-related stress has been found to have a detrimental effect on the individual’s productivity, quality of work, health, and personal life. Nursing has been identified as an occupation with high stress levels owing to complex job requirements that demand full physical and mental attributes, high responsibility, and job timings. Many Ayurveda interventions have demonstrated adaptogenic properties, and the proposed manuscript presents the design and protocol of the study, an Ayurveda intervention, Ayush-SR, in occupational stress in nurses. OBJECTIVE: To assess the clinical efficacy and safety of Ayurvedic medicine Ayush-SR in the management of occupational stress among nurses. MATERIALS AND METHODS: A prospective, randomized, double-blind, parallel-group, placebo-controlled, two-arm study has been designed to enroll a total of 120 nurses from a tertiary hospital in New Delhi, India. They will be screened for occupational stress based on a Professional Life Stress Scale (PLSS) score between 15 and 45, to meet the selection criteria. The participants will be randomized in a 1:1 ratio and allocated to two tabs of either Ayush-SR in the dose of 500 mg or its matching placebo twice a day after food for 90 days. The two-arm intervention comparison study includes a follow-up of 90 days with an assessment at the end of every 30 days. OUTCOME MEASURES: The primary outcome is the change in scores of PLSS. The secondary outcomes include the clinical safety assessment, changes in the scores of Quality of Life (by WHOQOL-BREF), and Manasa Bhava (Ayurveda-based psychobehavioral parameters) factors. Ethics: Ethics approval was taken from the Institutional Ethics Committee following which recruitment commenced in February 2021. Clinical Trial Registration: CTRI/2020/07/2026276 dated 01.07.2020