Efficacy and Safety of AYUSH SR tablet in the management of stress among University students – A double-blind randomized placebo-controlled study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the Score (greater than 5) of Kessler Psychological Distress Scale (K 10)from baseline
研究概览
简要总结
Stress remains highly prevalent among university students, making it imperative to explore therapeutic avenues for its prevention and reduction in this demographic. The relevance of Ayurvedic intervention becomes apparent, given its holistic approach, minimal adverse reactions, and significant potential in addressing lifestyle disorders. Valuable insights from clinical research in this area could play a pivotal role in effectively managing stress among university students.
Project Title: "Examining the Effectiveness and Safety of AYUSH SR Tablet in Alleviating Stress among University Students – A Double-Blind Randomized Placebo-Controlled Study"
Objectives: Primary Objectives:
- Evaluate the clinical efficacy of AYUSH-SR in managing stress among university students. Secondary Objective:
- Assess the clinical safety of AYUSH-SR in the management of stress among university students.
To achieve these objectives, students experiencing mild to moderate stress, as per the K10 scale, will be randomly assigned to two groups. Participants will receive either AYUSH SR tablets or AYUSH SR Placebo using a double-blind method. The study will meticulously evaluate the efficacy and safety of Ayush SR based on predefined criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in the Score (greater than 5) of Kessler Psychological Distress Scale (K 10)from baseline
时间窗: After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.
次要结局
- Incidence of adverse events during the study period(After enrollment assessment will be done on 30th, 60th and 90th day.)
- Change in the laboratry safety parameters(CBC,LFT and LFT)(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)(After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.)
研究者
Kuldeep Singh
Central Ayurveda Research Institute (CARI) under CCRAS New Delhi