A Clinical Study on Generalized Anxiety Disorder and its Management with a Polyherbal Unani Formulation- A Randomized Standard Controlled Clinical Trial

This study is a randomized, parallel group, active controlled clinical trial to evaluate the safety and efficacy of the aqueous extract form of a Unani polyherbal formulation in the management of Generalized Anxiety Disorder and to compare its efficacy with standard drug by using modern scientific parameter. The study will also be used to study the effects of the polyherbal formulation on quality of life of the patient. Anxiety disorders are among the most common of all psychiatric disorders throughout the world. An increase in global anxiety prevalence has a significant threat to the population’s well-being and quality of life. Conventional treatment for anxiety in Allopathic System of medicine include the Benzodiazepines, Antidepressants and Azapirones etc. They are useful for the short-term treatment of anxiety. However, regular long-term use carries a very high risk of tolerance and dependence. These drugs are associated with a wide range of adverse effects such as, sedation, mental confusion & weakness, impaired psychomotor performance, palpitation etc. In Unani System of Medicine, several drugs have been reported to have beneficial effects in anxiety disorders and are in clinical practice for a longer period of time. However, the safety and efficacy of these drugs have not been evaluated and documented on scientific parameters. Hence, there is a need to develop a safe, efficacious, and economical drug from the herbal treasury of Unani medicine for the treatment of Generalized Anxiety disorder.  The purpose of this study is to provide a safe, efficacious and economical drug for the management of Generalized Anxiety Disorder and to compare its efficacy with standard drug.