Efficacy of ayurveda medications, Brahmi vati and Saraswatarista, in generalized anxiety disorder- a randomized controlled trial

Background: Ayurvedic intervention ( Brahmi Vati with Saraswatarista) is explored for their possible role in management of Generalized Anxiety Disorder (GAD), a common psychiatric disorder. Objective: The objective of the study was to evaluate the efficacy of Brahmi Vati and Saraswatarista in GAD. Methods: Study is a randomized controlled clinical trial. Patients (n = 50) of GAD (Diagnostic and Statistical Manual of Mental Disorders (DSM-5 criteria), 18-60 years of age, either sex participated in the study. Participants were randomly divided into two groups. Group A, received escitalopram 10 mg/day for first 10 days followed by 20 mg/day for next 50 days. Group B, received Ayurvedic intervention ( Brahmi Vati 500 mg thrice a day (TID) and Saraswatarista 10 ml TID) for 60 days. Assessments were with clinical parameters like Hamilton Anxiety Rating Scale (HARS), GAD 7 scale (GAD 7), Beck Depression Inventory scale (BDI), Epworth sleepiness scale (ESS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life- BREF (WHOQOL-BREF), Clinical Global Improvement scale (CGI) and UKU-Side effect scale (UKU). These clinical assessments were measured on every 15th day during the intervention. Haemoglobin, liver function test (LFT), serum creatinine, serum urea were assessed before and after the study. Results: Study results indicate that both the groups were comparable in HARS, GAD7, BDI, WHOQOL-Bref and CGI-Severity. Group B was better in PSQI (standard mean difference = 0.87, 95% CI: 0.28, 1.43), ESS (standard mean difference = 1.42, 95% CI: 0.78, 2.02), CGI [global improvement (standard mean difference = 0.82, 95% CI: 0.23,1.28) and efficacy index (standard mean difference = 0.97, 95% CI: 0.37,1.54)] and had better adverse events profile (standard mean difference = 0.79, 95% CI: 0.21, 1.36). Both the groups had a good safety profile assessed through liver and renal profiles. Conclusion: Ayurveda interventions has additional advantages likes improvements in sleep profile, lesser adverse events and better global improvement in management of GAD. CTRI Registration Number is CTRI/2020/09/027750.