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VOLUME 4 , ISSUE 2 ( April-June, 2020 ) > List of Articles
GV Ramana, Kalpana B Kachare, Sudha K Chiluveri, BCS Rao
Keywords : Ayush-SR tablet, Clinical trial protocol, IT professionals, Occupational stress, Randomized placebo-controlled trial,Ayurveda medicine
Citation Information : Ramana G, Kachare KB, Chiluveri SK, Rao B. Ayurveda-coded Drug (Ayush-SR) for the Management of Occupational Stress among IT Professionals: A Study Protocol of a Randomized Double-blind Placebo-controlled Clinical Trial. J Res Ayurvedic Sci 2020; 4 (2):51-58.
License: CC BY-NC 4.0
Published Online: 21-12-2020
Copyright Statement: Copyright © 2020; Jaypee Brothers Medical Publishers (P) Ltd.
Background: The IT industry is an important profession now a day, but maximum occupational stress is found in it due to uncertain work environment, shift variations, long working hours, and lack of job security. For the management of occupational stress in IT workers, a clinical study has been undertaken with a coded Ayurvedic medicine well-known for anti-stress activities. Objective: To assess the clinical efficacy and safety of Ayurveda medicine Ayush-SR (a coded drug) in the management of occupational stress among IT professionals. Methods/design: It is a prospective, randomized double-blind, two-arm, placebo-controlled clinical study. A total 100 IT professionals (50 in each of the arm) will be selected, based on the study inclusion criteria. Group I will receive Ayush-SR tab 1 g twice a day after food and the control arm will receive placebo 1 g twice a day after food for 90 days. The statistical analysis will be done at the end of the trial period to compare the changes in the assessment parameters from the baseline. The study has been approved by the IEC and also registered in CTRI with registration number CTRI 2019/08/020798. Outcome measures: The primary outcomes include change in the Occupational Stress Index (OSI) score. Secondary outcomes include changes in WHO Well-being Index (1998 version) and changes in the scores of manasa bhava pareeksha. Discussion: The protocol is designed for finding of better clinical outcome and safety profile in management of occupational stress. If found effective, this drug can be listed in management of occupational stress at clinical practice in terms of better efficacy, safety, and cost-effectiveness intervention. The result will be published in a peer-reviewed journal.