A Randomized, Double-Blind, Placebo-Controlled Trial of Kava Extract (KavasoulTM) in Adults: Effects on Stress and Anxiety.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a single-centre, randomized, double-blind, placebo-controlled clinical study designed to evaluate the effectiveness and safety of Kava extract (Kavasoul™) in adults experiencing mild to moderate stress and anxiety. A total of 40 eligible participants aged 18 to 65 years will be randomly assigned to receive either Kava extract (150 mg per day) or a placebo for a period of 6 weeks.
The primary aim of the study is to assess whether Kava extract reduces stress and anxiety levels compared to placebo. Stress and anxiety will be evaluated using validated questionnaires, including the Hamilton Anxiety Rating Scale (HAM-A) and the Perceived Stress Scale (PSS-14). Secondary objectives include assessing changes in mood, sleep quality, vital signs, and selected blood biomarkers related to stress and neurotransmitter balance.
Participants will attend study visits at baseline, during treatment, at the end of treatment, and during a short follow-up period. Safety will be monitored throughout the study by recording adverse events, vital signs, and laboratory test results, including liver function tests. The study will be conducted in accordance with Good Clinical Practice guidelines and ethical principles, and written informed consent will be obtained from all participants prior to participation.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18–65 years 2.Experiencing mild to moderate stress or anxiety (PSS- 14 score greater than 19 and HAM-A score greater than 18) 3.Generally healthy, with no significant medical or psychiatric conditions affecting participation 4.Able to use a smartphone, tablet, or computer to complete study assessments 5.Willing and able to provide written informed consent.
排除标准
- •Severe psychiatric disorder (bipolar disorder, psychosis, major depression with suicidal ideation).
- •Use of anxiolytics, antidepressants, sedatives within 30 days.
- •Known liver disease or abnormal liver function tests.
- •Substance abuse within 6 months.
- •Pregnancy, lactation, or planning pregnancy.
- •Participation in any other clinical trial within 30 days.
- •Any condition that may interfere with participation or data quality.
研究者
Dr N Praveen Kumar
Samiksha Heart And Diabetic Care