An open clinical trial to evaluate the efficacy of Pankajakasthuri antistress formulation in the management of patients diagnosed with generalized anxiety disorder

Generalized Anxiety Disorder (GAD) is a prevalent mental health condition characterized by excessive worry and anxiety. Despite the availability of pharmacological interventions, many individuals seek complementary and alternative treatments due to concerns about side effects and the desire for more holistic approaches. Pankajakasthuri Antistress Formulation (PAF), a herbal formulation for its anxiolytic properties. However, its efficacy in GAD management has not been extensively studied in clinical settings. This study aims to assess the efficacy of Pankajakasthuri Antistress Formulation as an adjunctive therapy in the management of patients diagnosed with Generalized Anxiety Disorder. An open-label clinical trial will be conducted involving patients diagnosed with GAD according to DSM-5 criteria. Participants will receive Pankajakasthuri Antistress Formulation as an adjunct to standard pharmacotherapy or psychotherapy for a duration of 12 weeks. Outcome measures including changes in anxiety symptoms, quality of life, and adverse effects will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks using standardized psychometric scales such as the Hamilton Anxiety Rating Scale (HAM-A) and the Generalized Anxiety Disorder 7-item Scale (GAD-7). This open clinical trial will provide valuable insights into the potential role of Pankajakasthuri Antistress Formulation as an adjunctive therapy in the management of Generalized Anxiety Disorder. If found effective and well-tolerated, PAF could serve as a promising alternative or complementary treatment option for individuals with GAD, contributing to the broader spectrum of available therapeutic interventions for this prevalent mental health condition.