ong Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized root extract of Withania Somnifera) in Adults: A Prospective, Observational Study

Ixoreal Biomed Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1. Adults (male and female) aged between 18 and 65 years
•2. Prescribed KSM-66 Ashwagandha by their clinicians for long-term period
•3. No plan to commence any other alternative treatment modality for their conditions
•4. Willingness to sign an informed consent document and to comply with all study related 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 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.
•3. Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
•4. Patients with known post-traumatic stress disorder (PTSD)
•5. Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study
•6. Patients with known hypersensitivity to Ashwagandha
•7. Patients who had participated in other clinical trials during previous 3 months
•8. Patients who have any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol

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