Study to Investigate Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance: A Perspective, Randomized, Double-blinded, Placebo-controlled, Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Changes in sleep quality
研究概览
简要总结
This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for the relief of stress, depression and anxiety in healthy adults.
详细描述
Lemon balm (Botanical name: Melissa officinalis L.) is a herbal plant belongs to the Lamiaceae (mint) family, and currently of wide scientific interest as possible adjuvant for calming effect. Lemon balm is one of the most popular and widely used medicinal herbs in central and southern Europe, the Mediterranean region, and west Asia. The European Scientific Cooperative on Phytotherapy (ESCOP) recommends the use of lemon balm to relieve of mild symptoms of anxiety, including mental stress, restlessness, and irritability. Historically, Lemon balm has been widely used in Asian traditional medicine as a sedative to treat many psychiatric disorders, such as stress, depression, anxiety, and insomnia. Lemon balm has shown anti-depressant, anxiolytic, and anti-insomnia effects both in human clinical trials and in animal model studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals, aged 18 - 65 years
- •Individuals suffering from moderate degree of depression, anxiety, and stress with DASS scores ≥14, ≥10, and ≥19, respectively, or individual with sleep problems with Pittsburgh Sleep Quality Index (PSQI) score ≥
- •Willing to participate in the study
排除标准
- •Current use of prescribed medication or supplements for neuropsychiatric and sleep disorders
- •Known history of neuropsychiatric or sleep disorders
- •Current use or history of illicit substances misuse
- •History of any allergic reactions to ingredients of the Lemon Balm Extract
- •Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90, or other cardiovascular disease
- •Hyperthyroidism or Diabetes mellitus or cancer
- •Use of blood thinners like Coumadin (warfarin) or Plavix (clopidogrel), Glaucoma medications like Travatan (travoprost), Chemotherapy drugs like tamoxifen and Camptosar (irinotecan)
- •Severe medical problem, which in the opinion of the investigator would pose a safety risk to the subject
结局指标
主要结局
Changes in sleep quality
时间窗: 3 weeks
Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score
Changes in the level of depression
时间窗: 3 weeks
Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)
Changes in the level of anxiety
时间窗: 3 weeks
Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)
Changes in the level of stress
时间窗: 3 weeks
Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)
次要结局
- Changes in Positive and Negative Emotional Feelings(3 weeks)
- Changes in mental wellbeing(3 weeks)
- Changes in the Quality of Life (QoL)(3 weeks)