A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder

Inclusion Criteria: * Adult men and women between the ages of 18 and 65 years (who have completed their 18th birthday but have not completed their 66th birthday) with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR, APA, 2000) diagnosis of GAD - Generalized Anxiety Disorder. * Hamilton Anxiety Rating Scale (HAM-A) total score ≥ 20 at the screening and randomization visits. * HAM-A Item 1 (anxious mood) ≥ 2 at the screening and randomization visits. * HAM-A Item 2 (tension) ≥ 2 at the screening and randomization visits. * Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤ 12, with MADRS items #1 and #2 "apparent sadness" and "reported sadness" ≤ 2 at the screening and randomization visits. * Clinical Global Impression-Severity of Illness (CGI-S) score ≥ 4 at the screening and randomization visits. * Written Informed Consent present prior to conduct of any study related procedures Exclusion Criteria: * Any DSM-IV-TR Axis I disorder other than GAD within 6 months prior to the screening visit. * Any DSM-IV-TR Axis II disorder that is likely to interfere with the patient's ability to participate in the study. * Current serious suicidal or homicidal risk, MADRS Item 10 (suicidal thoughts) score \> 1, at the screening or randomization visit or a suicide attempt in the 6 months prior to screening. * Substance or alcohol dependence within 6 months prior to screening. (except Nicotine and/or caffeine) * Clinically significant deviation from the reference range in clinical laboratory test results during the screening phase and prior to randomization. * Women who test positive for pregnancy at the screening visit or women who are breast feeding at the screening visit. * Any thyroid laboratory measures that are considered clinically significant during the screening phase. * Current (or within past 2 months prior to screening) use of any extract of Withania Somnifera. * Any known allergy to Withania Somnifera extracts. * Current (or within the past 2 months prior to screening) over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3. * Specific Concomitant medicines (a table will specify "allowed" and "disallowed" medicines). \[Appendix 13\] * Currently (or within the past 2 months prior to screening) receiving any psychotropic medicines (e.g. Anti-anxiety drugs or anti-depressants, or anti-psychotic agents or mood stabilizers). * Currently (or within the past 2 months prior to screening) receiving any investigational drugs or medical devices. * Currently (or within the past 2 months prior to screening) undertaking psychotherapy for anxiety or depression. * Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.