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Clinical and safety evaluation of Brillia in patients with Anxiety Disorder

Background:According to the American Psychiatric Association, anxiety disorders are the most common type of psychiatric disorder. Many patients with anxiety disorders experience physical symptoms related to anxiety and subsequently visit their primary care providers instead of psychiatrists. Despite the high prevalence rates of these anxiety disorders, they often are under-recognized and undertreated clinical problems.

According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), anxiety disorders include disorders that share features of excessive fear, anxiety and related behavioral disturbances. These disorders include separation anxiety disorder, selective autism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, generalized anxiety disorder, substance/medication-induced anxiety disorder, and anxiety disorder due to another medical condition. Brillia uses the combined sciences of homeopathy and antibodies, which is a new way of treatment. The active ingredient of Brillia, Lapine S-100 immune globulin, is produced using antibodies to the brain-specific S-100 protein (S-100B), which acts as an essential regulator for many different intracellular and extracellular brain processes. To establish the clinical efficacy of Brillia for the treatment of anxiety disorders, the conduct of clinical study was relevant. Thus, to determine the efficacy and safety of Brillia for the treatment of anxiety disorders and Attention-Deficit/Hyperactivity Disorders, two clinical studies were designed for each indication. One such clinical research on the patients with anxiety disorders is explained in this article, and results from the other clinical study on the patients with Attention-Deficit/Hyperactivity Disorder is described in another publication/section.

Methods: A double-blind placebo-controlled randomized study of Brillia evaluating clinical efficacy and safety for children with anxiety disorders. Before the patients were recruited in the study, the patients of the legal guardians of the patient were explained about the study and signed informed consent was received. Any patientrelated information that was collected during the conduct of the research is handled confidentially.

Prior to inclusion in the study, the patients or their legal guardians were provided with information about the study and signed an informed consent form. Patient information collected during the study is strictly confidential.

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