A Prospective, Open-Label, Non-Randomised Study to Assess the Efficacy and Safety of Zero Tension Tablets in Patients With Stress, Anxiety and Insomnia Disorders

Abstract

Introduction: Passiflora incarnata, Valeriana wallichii and Withania somnifera are known to have psychotropic effects. These plants have been reported to alleviate stress, anxiety, and insomnia. This study aimed to evaluate the safety and efficacy of Zero Tension tablets in patients with mild to moderate stress, anxiety, and insomnia disorders. Methods: This study was a prospective, open-label, non-randomised study on patients (n = 100) with mild to moderate stress, anxiety, and insomnia disorders. All participants received two tablets with lukewarm water daily at night for 56 days. Primary outcomes were changes in the Hamilton anxiety scale (HAM-A), perceived stress scale (PSS), insomnia severity index, general health scores, serum levels of cortisol and dehydroepiandrosterone (DHEA) from day 0 to day 56. Secondary outcomes included adverse effects, changes in vital signs, haematological parameters, and serum biochemistry. Datasets were analysed at different assessment points using a t-test and one-way analysis of variance (ANOVA), as applicable. Results: Consumption of Zero Tension tablets significantly (p<0.001) reduced HAM-A, PSS, insomnia severity, and general health scores. Most participants experienced reduced stress, anxiety, and insomnia symptoms after 56 days of treatment. The serum cortisol and DHEA levels were also mildly reduced. No significant adverse effects or changes in vital signs, haematological, or blood biochemistry parameters were observed. Conclusion: The results suggested that the Zero Tension tablet is safe and could be an effective alternative to improve stress, anxiety and sleep disorders.