Study protocol of a prospective randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of AYUSH-SR tablet in the management of stress among university students
Kuldeep Singh, Shaizi Layeeq, Bharti Gupta, Rabya Umman, Avinash Jain, Swati Sharma, Subhash Sharma, Rakesh Kumar Rana, Arunabh Tripathi, Bhogavalli Chandrasekhara Rao, Srikanth Narayanam, Rabinarayan AcharyaAbstract
BACKGROUND:
University students are increasingly affected by stress due to academic demands, social pressures, and uncertainties about the future. This often leads to anxiety, depression, sleep disturbances, and impaired cognitive and physical health, adversely impacting academic performance. Ayurveda, a traditional holistic system of medicine, offers a potential complementary approach to stress management by addressing underlying lifestyle and emotional factors.
OBJECTIVE:
The objective of the study is to assess the clinical efficacy and safety of AYUSH-SR in the management of stress among university students.
MATERIALS AND METHODS:
This was a prospective, randomized, double-blind, placebo-controlled, parallel-group design being conducted among 70 university students in New Delhi, India. Participants are screened using the Kessler Psychological Distress Scale (K10), and eligible individuals are randomized (1:1) to receive either AYUSH-SR or a matched placebo (500 mg tablet), administered as two tablets twice daily (1 g [500 mg × 2] tablet twice a day) for 90 days. Assessments are scheduled at baseline, and on days 15, 30, 45, 60, 75, 90, and 105.
RESULTS:
The primary outcome was a reduction in K10 scores from baseline, assessed at days 30, 60, and 90. Secondary outcomes included incidence of adverse events, changes in laboratory safety parameters (complete blood count, liver function test, and kidney function test at baseline and day 90), and improvements in quality of life as measured by the World Health Organization- five wellbeing index (WHO-5 ) at the same intervals.
CONCLUSION:
Early stress management through evidence-based Ayurvedic interventions, especially among university students, may offer a sustainable strategy to reduce stress-related mental health challenges and support overall academic well-being.
Clinical Trial Registration:
CTRI/2024/01/060996, dated January 1, 2024.