This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.
Adults (male and female) aged between 18 and 65 years.
Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit.
Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit.
Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
Patients having a total score of less than 14 on HAM-A at screening.
Patients currently (or within the past 4 weeks prior to screening) taking any over-the-counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3, etc.
Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
Parallel
Proprietary Blend of Ashwagandha
Dietary supplementOne capsule (300mg) is taken twice daily with water
KSM-66 Ashwagandha root extract
Dietary supplementOne capsule (300mg) is taken twice daily with water
Placebo
Dietary supplementOne capsule (300mg) is taken twice daily with water
Serum cortisol level
Perceived Stress Scale Score (PSS)
The Perceived Stress Scale (PSS-10) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. The questions in the PSS ask about feelings and thoughts during the last month.
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings. The HAM-A scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Profile of Mood States (POMS, abbreviated version)
The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem-related affect, Vigor, Confusion, and Total Mood Disturbance.
Oxford Happiness Questionnaire
The Oxford Happiness Scale (OHS) is a psychological assessment tool designed to measure an individual's subjective level of happiness. It was developed by researchers Michael Argyle and Peter Hills at the University of Oxford. The scale is widely used in positive psychology and well-being research to evaluate happiness as a multidimensional concept, encompassing emotional, cognitive, and social aspects.
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SF Research Institute, Inc.
Lead sponsor
Agaja Pharma Pvt. Ltd.
Collaborator
