Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety

This study is a multi-centre, multi-national, prospective, randomized, double-blind placebo-controlled study. The study lasts 12 weeks which includes 2 on-site visits and 2 remote visits. Primary objective is to compare the efficacy of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety. Secondary objectives to compare the safety of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety.

Inclusion Criteria:Adults (male and female) aged between 18 and 65 yearsExperiencing signs and symptoms suggestive of high 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 between14 and 30 at the screening/randomization visitPerceived Stress Scale (PSS) score ≥13 at the screening/randomization visitBMI between 20 and 35No plan to commence new treatments over the study periodNon-smokerMedication-free (any medications known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pill are permissible.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.Exclusion Criteria: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 total score 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 depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and maniaPatients with known post-traumatic stress disorder (PTSD) 6. Patients who have an established practice of meditation and relaxation techniques for three or more monthsPatients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the studyPatients with history of alcohol, tobacco dependence or with any substance abusePregnant and lactating women or suspected to be pregnantPatients with known hypersensitivity to AshwagandhaPatients who had participated in other clinical trials during previous 3 monthsPatients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol