Safety of Ashwagandha (Withania somnifera) Root Extract: An Open-Label, Non-Comparative, Prospective Study in Healthy Subjects

D Y Patil Medical College Nerul0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•1 Both Adults (male and female) aged between 18 and 65years
•2 Participate should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study
•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 History of Alcohol or smoking abuse.
•2 History of hypersensitivity to Ashwagandha.
•3 Taking nutritional or energy supplements, medication, or steroids,
•4 Any history of drug abuse.
•5 Having any clinical abnormalities.
•6 Simultaneously participating in any other clinical trial or participated in the past three months.
•7 Participants who use medication for blood pressure, use beta-blockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and
•8 Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
•9 Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
•10 Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
•11 Patients with post traumatic disorder.
•12 Have an established practice of meditation for three or more months.
•13 Pregnant and lactating women.
•14 Participation in other clinical trials during previous 3 months
•15 Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.

发起方

D Y Patil Medical College Nerul