Efficacy and Safety of AYUSH SR tablet in the management of stress among University students –A double-blind randomized placebo-controlled study - NI

Central Council for Research in Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Students of any gender aged 18 – 30years.
•2.Students with mild to moderate stress (score 20 to 29) based on Kessler Psychological Distress Scale (K10).
•3.Students willing to participate in the clinical study and provide the signed informed consent.

•1.Students with age below 18 years and above 30 years
•2.Students suffering from other Psychiatric disorders or under medication for any psychiatric conditions.
•3.Students with history of known cases of any major systemic illness such as cardiovascular, cerebrovascular, neurological, musculoskeletal diseases, thyroid disorders, immunosuppressive or immunodeficiency disorders and active malignancy
•4.Students with concurrent hepatic dysfunction (defined as AST and or ALT greater than 2 times of the upper normal limit), or renal dysfunction (defined as serum creatinine greater than 1.2mg per lt), UNCONTROLLED PULMONARY DYSFUNCTION (ASTHMATIC AND COPD),uncontrolled diabetes mellitus with HbA1c above 8, uncontrolled hypertension BP greater than Systolic 160 and diastolic 100 mm hg
•5.women who are planning to conceive, pregnant or lactatic women.
•6.History of substance abuse, alcohol intake, chronic smoking or participants who are having any type of alcohol or smoking or substance or drugs etc.
•7.History of any hypersensitivity to any of the trial drug or their ingredient.
•8.Students who have completed participation in any other clinical trial during the past 3 months
•9.Any other condition which the investigator think may jeopardize the subject and or study.

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