A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvements in Sleep Quality and Mental Well-Being
研究概览
简要总结
This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21-65 years
- •Male or female
- •Good general health
- •Experience daily feelings of stress and anxiety within the past two weeks
- •Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks
- •Have used alcohol products to help relax or sleep within the past two weeks
- •Experience tension in the body within the past two weeks
- •Experience problems with relaxing in the evening within the past two weeks
- •Willing to abstain from alcohol for the duration of the study
- •Willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study
排除标准
- •Chronic health conditions, including oncological and psychiatric disorders
- •Taking SSRIs, sedative, or blood pressure-lowering medications
- •Pregnant, breastfeeding, or planning to conceive within the next three months
- •Currently enrolled or planning to enroll in another research trial over the next eight weeks
- •History of substance abuse
- •Known serious allergic reactions requiring an Epi-Pen
结局指标
主要结局
Improvements in Sleep Quality and Mental Well-Being
时间窗: Baseline, Week 2, Week 4, Week 6, and Week 8
Changes in sleep quality, mental well-being, stress, and feelings of anxiety will be assessed using self-assessment questionnaires. Participants will complete these questionnaires at specified intervals throughout the study to evaluate the effectiveness of the herbal tincture compared to the placebo.
次要结局
- Changes in Sleep Length and Quality(Baseline, Week 4, and Week 8)