Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pittsburgh Insomnia Rating Scale
研究概览
简要总结
This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.
详细描述
Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Lavender Essential oil as medication and almond oil as placebo put in similar dark buttle and the head of placebo bottle aromatized whit Lavender Essential oil and all of participants, care provider, investigator and outcomes assessor will be blind.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 2
- •Age between 25-65 years old
- •Fasting Blood Sugar between 70-130
- •2 hour post prandial glucose less than
- •HbA1C less than 7
- •Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.
排除标准
- •Any systemic illnesses
- •Use of sedative or antidepressant drugs
- •Pregnancy
- •Lactation
- •History of allergic reaction to Lavender
- •History of allergic rhinitis, asthma and respiratory disorders
- •Headache that start with smell
- •Cigarette smocking or substance abuse
- •Hospitalization or surgery within 1 months ago.
- •Work shift
研究组 & 干预措施
vehicle (Almond oil)
干预措施: Placebos (Drug)
Lavender oil
干预措施: Lavender Oil (Drug)
结局指标
主要结局
Pittsburgh Insomnia Rating Scale
时间窗: 4 weeks
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
次要结局
- hip circumference(4 week)
- 2 hours Post Prandial Glucose(4 week)
- Fasting Blood Sugar(4 week)
- C Reactive Protein(4 week)
- Uric acid(4 week)
- High Density Lipoprotein(4 week)
- Aspartate Aminotransferase(4 week)
- waist circumference(4 week)
- Creatinine(4 week)
- Alanine Aminotransferase(4 week)
- Body Mass Index(4 week)
- Serum Insulin(4 week)
- Triglyceride(4 week)
- Cholesterol(4 week)
- weight(4 week)
- Low Density Lipoprotein(4 week)
- Diastolic Blood Pressure(4 week)
- Systolic Blood Pressure(4 week)
研究者
Mesbah Shams, MD
Associate professor of internal medicine and endocrinology
Shiraz University of Medical Sciences