EFFECT OF BAY LEAF ON QUALITY OF SLEEP IN PATIENTS WITH PRIMARY INSOMNIA: A RANDOMIZED CONTROL STUDY.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Primary insomnia is a type of sleep disturbance characterized by a subjective complaint of difficulty falling or staying asleep, or of having an unrefreshing sensation when sleeping, that not attributable to a coexisting mental or physiological condition. About 30% of the general population suffers from insomnia. The perennial shrub known as bay leaf (Laurus nobilis) is a member of the Laurel family. A study discovered that the chemical linalool, found in bay leaves, lengthened people’s sleep duration. The drop in blood cortisol levels in healthy volunteers drinking Laurus nobilis tea, suggesting a potential benefit in lowering the risk of stress-related disorders. Criteria for Diagnosis: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be applied during screening. Bay leaf decoction – 3 grams (1 teaspoon) of bay leaf powder is added to 100ml of water and bought to a boil and is given to the subject to sip it warm. The data from insomnia severity index( ISI) and serum cortisol levels will be collected at baseline and post intervention [post 90 Days]. The aim is to study the effect of bay leaf decoction on quality of sleep in patients with primary insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 69.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects who are diagnosed as primary insomnia by DSM 5 criteria.
排除标准
- •Individuals with psychotic conditions.
- •Individuals under any medications.
- •Individuals with other serious illness.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Pre, Post
次要结局
- Serum cortisol level(Pre, Post)
研究者
Dr Priyadharshini D
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences
