An Ayurvedic intervention (AYUSH SR Tablet) for the management of stress among university students
- Conditions
- Health Condition 1: F439- Reaction to severe stress, unspecified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Score (greater than 5) of Kessler Psychological Distress Scale (K 10)from baselineTimepoint: After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.
- Secondary Outcome Measures
Name Time Method Change in the laboratry safety parameters(CBC,LFT and LFT)Timepoint: Assessment will be done before treatment on BASELINE and on 90th day.;Change in the quality of life parameters (assessed through WHO-5 Well being Index)Timepoint: After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.;Incidence of adverse events during the study periodTimepoint: After enrollment assessment will be done on 30th, 60th and 90th day.