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

Shri Kartikeya Pharma Pvt Ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Adults (male and female) aged between 18 and 65 years
•2.Experiencing 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.)
•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.Non-smoker
•8.Medication-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.
•9.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, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
•2.Patients having total score 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 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)
•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 history of alcohol, tobacco dependence or with 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 previous 3 months
•12.Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol

发起方

Shri Kartikeya Pharma Pvt Ltd