STUDY PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE ADD-ON EFFECT OF AYURVEDIC MODULE ON ANTI-INFLAMMATORY CYTOKINE IL-10 IN NIGHT SHIFT WORKERS

Introduction: Different occupations and working conditions produce varied effects on the health of the worker. Nowadays, almost a fifth of the worldwide workforce is engaged in shift work. Shift work, and night shift in particular, is one of the most frequent reasons for the disruption of circadian rhythms, causing significant alterations of sleep and biological functions, which, in turn, can affect the physical and psychological well-being and negatively condition work performance. Night shift work induces sleep deprivation which, in turn, alters the daily levels of alertness and job performance, favoring fatigue. Decreased job satisfaction is strongly associated with increased job stress. Apart from pollution, drugs and pathogens, stress is also found to be a major contributing factor for inflammation. According to past studies, pro-inflammatory cytokines were found to be elevated in highly stressed individuals. Therefore, in the present study an attempt is made to develop and validate the Ayurveda Module for night shift workers and to evaluate the difference in levels of anti-inflammatory marker IL-10 after intervening the Ayurveda module along with Yoga module for lifestyle of night shift workers. Materials and Methods: It’s a randomized controlled trail comprising two group each of 94 subjects. The participants in the control group will receive the pre-established yoga module as intervention and trail group will receive the newly developed ayurveda module along with yoga module. The primary outcome is to develop and validate the Ayurveda Module and to evaluate the add on effect of ayurveda module on the levels of anti-inflammatory marker IL-10. The secondary outcome is to evaluate the difference in the levels of PSQI (Pittsburg’s Sleep Quality Index) and WHO-QoL (Quality of Life) scores. Conclusion: This study can give a good integrative solution for the preventive aspect while dealing with the health issues related with the night shift workers occupation. Ethics: Ethical clearance has been taken form the IEC committee, All India Institute of Ayurveda, New Delhi. Clinical trial registration: The trail is registered with The Clinical Trail Registry of India (CTRI).