Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Eligibility Criteria

• 1. Adults (male and female) aged between 18 and 65 years.
• 2. 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.).
• 3. Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit.
• 4. Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit.
• 5. BMI between 20 and 35.
• 6. No plan to commence new treatments over the study period.
• 7. Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills are permissible.
• 8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
• 1. 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.
• 2. Patients having a total score of less than 14 on HAM-A at screening.
• 3. 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.
• 4. Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
• 5. Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
• 6. Patients who have an established practice of meditation and relaxation techniques for three or more months.
• 7. Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
• 8. Patients with a history of alcohol, tobacco dependence, or any substance abuse.
• 9. Pregnant and lactating women or suspected to be pregnant.
• 10. Patients with known hypersensitivity to Ashwagandha.
• 11. Patients who had participated in other clinical trials during the previous 3 months.
• 12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.