A single-arm clinical trial to evaluate the safety and efficacy of Mentacalm tablets in reducing stress and anxiety in adults

Vaidya, V G and Mali, Sandeep and Ganu, Gayatri Pramod (2025) A single-arm clinical trial to evaluate the safety and efficacy of Mentacalm tablets in reducing stress and anxiety in adults. World Journal of Biology Pharmacy and Health Sciences, 22 (1). pp. 172-184. ISSN 2582-5542

Introduction: The prevalence of stress and anxiety has significantly increased in recent years, with approximately one-third of the population reporting symptoms. Mentacalm tablets contain ingredients that have the potential to calm the mind, reduce brain hyperactivity, and improve mood and anxiety. Materials and Methods: This was a single-arm, open-label clinical trial of Mentacalm tablets for reducing stress and anxiety in adults. The study lasted 68 days, and each participant was administered one Mentacalm tablet twice a day after food, orally. The research objectives were to evaluate changes in the Perceived Stress Scale (PSS) score, Serum cortisol levels, Depression Anxiety Stress Scale (DASS), Hamilton Anxiety Rating Scale (HAM-A) score, Penn State Worry Questionnaire (PSWQ) score, Profile of Mood State (POMS) questionnaire score, and World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) score were done at screening, day 30 and day 60. Changes in Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ) score were assessed after stopping treatment for 1 week (day 68). Results: Administration of the Mentacalm tablets yielded significant positive effects as demonstrated by the reduction in stress-related symptoms and markers indicated by cortisol levels, PSS score, DASS score, HAM-A score, PSWQ score, Bad Mood- POMS score, and increase in Good Mood- POMS score, MSRMWQ score and WHOQOL- BREF score. Conclusion: Research suggests that Mentacalm tablets are a promising supplement for managing stress and anxiety in adults, enhancing mental health, mood, and overall quality of life.