跳至主要内容
临床试验/CTRI/2025/09/094786
CTRI/2025/09/094786尚未招募2 期

EFFECT OF BAY LEAF ON QUALITY OF SLEEP IN PATIENTS WITH PRIMARY INSOMNIA: A RANDOMIZED CONTROL STUDY.

Dr Priyadharshini D1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

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

发起方
Dr Priyadharshini D
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priyadharshini D

Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences

研究点 (1)

Loading locations...

相似试验