A study to evaluate efficacy and safety of Ashwagandha in improving quality of life in healthy adults with stress & anxiety.

Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1 Male and female healthy adults 21 to 54 years old.
•2 Body Mass Index (BMI) in the range of 18 to 32 kg/m2.
•3 Subjects free of any psychological or psychiatric conditions except stress & anxiety.
•4 Adults with perceived stress scale score less than 25 and more than 14.
•5 Adults complaining with anxiety,fatigue,loss of appetite,Insomnia and loss of concentration.
•6 Subject must be willing and able to adhere to the assessments,visit schedules,
•prohibitions and restrictions,as described in this protocol.
•7 Willing to sign informed consent.

•1 Pregnant and lactating female or female having the intention to be pregnant within next
•three months.
•2 Education level below 8th grade of schooling.
•3 Unable to read or understand English or having no working knowledge of English.
•4 History of alcohol abuse, excessive smoking with more than 5 cigarettes a day.
•5 Established/ diagnosed neurological or psychiatric disorders.
•6 With chronic gastrointestinal diseases, severe immune deficiency.
•7 Lipid profile, haematological parameters, Glycaemic parameters above normal limits.
•8 History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements
•(including Vitamin E) or any alternative therapies in the last one month.
•9 History of bone marrow disorders.
•10 Acute medical/surgical complications which require hospitalization.
•11 Subjects with history of clinically significant thyroid disorder (hypo or hyper),
•cardiovascular, haematological,hepatic (SGOT or SGPT levels >2 Upper Limit of
•Normal),renal (serum creatinine>=1.3 mg/dl), respiratory,or genitourinary
•abnormalities or diseases.
•12 A history of significant multiple and/or severe allergies or anaphylactic reactions.
•13 Subjects with known history of hypersensitivity to the investigational product.
•14. Subject has participated in any clinical trial within last 3 months.
•15. Any other condition which the Principal Investigator thinks may jeopardize the study.

发起方

Sami Labs Limited