Efficacy and Safety of ALERT Capsule in the Managment of Generalized Anxiety Disorder-An Open Label Clinical Study

Generalized anxiety disorder (GAD) is characterized by excessive,uncontrolled and often irrational worry, that is, apprehensive expectationabout events or activities. In India, around 6-10% population is suffering fromGAD. Anxiolytic drugs are extremely tempting, and prescribed to millions of individualssuffering from anxiety and stress. But some of them (like Benzodiazepines,Buspirone) are known to produce side effects like hypotension, nausea, memoryloss, sexual dysfunction, headache etc. Thus, it needs tosearch for safe and effective solution. Thepresent study is to be initiated for evaluating clinical efficacy and safety ofAlert Capsule in the management of Generalized Anxiety Disorder (GAD). Diseasespecific inclusion and exclusion criteria have been selected and shallbe employed for the enrolment of patients. For the assessment of efficacyappropriate subjective parameters like Generalized Anxiety Disorder 7 (GAD-7)scale, Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale(HAM-D), WHO Quality of life BREF, Pittsburg sleep quality index, Clinicalglobal Impression will be used. On another hand, bio-chemical parameter likeserum cortisol level will be analysed as anxiety marker other investigationslike liver Function test, Renal Function test, Complete blood profile like Hb,ESR, RBC, PCV, MCV, MCH, MCHC, WBC, WBC Differential, total platelet count, MPVand blood clotting time will be evaluated. Urine & Stool routineexamination will also be carried out.   Total study period in a patient will be of 60days. Treatment with test drug will be provided for 1 month and followed by 1month period of placebo interventional observation period. Follow-up visit isto be scheduled at every 2 weeks of interval with 4 follow up. All thelaboratory investigations will be carried out at base line and 30th day.However evaluation with all the clinical assessment scales will be carried outat all the visits.  Appropriate statisticstools shall be applied to find out statistical significance of undergoingtherapy.