Research Study Summary
A clinical trial to evaluate treatments using Sensoril® and Placebo for patients with Generalized Anxiety Disorder
Research Study Title
A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.
Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown
potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in
animal and human studies. Furthermore, controlled, single site human studies have shown the
anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel
Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with
Generalized Anxiety Disorder. The primary objectives of this study are to assess the
efficacy and safety of Sensoril® for patients with moderate or greater severity of symptoms
associated with Generalized Anxiety Disorder.
The Primary Efficacy endpoint in this study will be determined by a statistically
significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale
scores in the Sensoril® treated group versus those receiving placebo.
The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo
Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last
Greater remission rates (HAM-A total scores ≤ 7) at week 8
Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety
Greater improvements on CGI - severity scores from baseline to last value.
A higher percentage of subjects rated as "much improved" or "very much improved" on the
CGI - Improvement subscale at the last value.
Serum cortisol and DHEA-S levels will be assessed between the two treatment groups.
These biomarkers are indices of stress and it is hypothesized that improvement in
levels of these stress indices will favor the Sensoril® treated group.
- Patient reported outcomes for sleep and calmness will be assessed between the two
The safety endpoints will be determined by assessments of adverse and serious adverse
events, physical examination, vital signs, EKG, and clinical laboratory measures. Clinical
measures with laboratory defined reference ranges and vital signs will be assessed.
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