Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Insomnia severity index
研究概览
简要总结
The objectives of this study were to evaluate efficacy and safety of longan syrup in healthy volunteers with insomnia. Subjects will take 15 ml of longan syrup once a day for 3 months. They will be investigated their insomnia using Insomnia Severity Index (ISI) questionnaire, Thai- The Pittsburgh Sleep Quality Index (PSQI) questionnaire,STOP - BANG questionnaire, Epworth Sleepiness Scale (ESS) questionnaire, Actiwatch, plasma cortisol, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine (Cr), blood urea nitrogen (BUN), fasting blood sugar, HbA1C, complete blood count (CBC), hemoglobin, lipid profile, phosphate level, saliva cortisol, and urine melatonin before and after taken longan syrup.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35-65 years
- •Insomnia severity index (ISI) more than 7
- •Thai- The Pittsburgh Sleep Quality Index (PSQI)) more than 5
- •STOP - BANG less than 5
- •No diabetes mellitus and thyroid dysfunction
- •Fasting plasma glucose less than 126mg/dl
- •Can communication (reading and writing)
- •Be willing to be subjects in this study
排除标准
- •Know longan allergy or have history of adverse events from longan
- •Take benzodiazepine, melatonin, valerian, and St Johns Wort in 1 month before this study starting
- •Take medicines, herbs, or food supplements including thiazide diuretics, beta-blockers ,and estrogen that have an effect on blood sugar level in 1 month before this study starting
- •Cannot control comorbidity diseases
- •Irregular working hours
- •Pregnancy or breast feeding
- •Participated in other studies
结局指标
主要结局
Insomnia severity index
时间窗: 3 months
Insomnia severity index after taken longan syrup will be less than before taken. The minimum and maximum values are 0 and 28 scores, respectively. Higher scores mean a worse outcome.
次要结局
- Urine Melatonin(3 months)
- Serum triglyceride(3 months)
- Glycohemoglobin(3 months)
- Alanine aminotransferase in serum(3 months)
- Actiwatch value(3 months)
- Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire(3 months)
- Thai- The Pittsburgh Sleep Quality Index(3 months)
- Serum cortisol(3 months)
- Serum High-density lipoprotein(3 months)
- Serum Low-density lipoprotein(3 months)
- Serum total cholesterol(3 months)
- Aspartate aminotransferase in serum(3 months)
- Alkaline phosphatase in serum(3 months)
- Serum creatinine(3 months)
- Blood Urea Nitrogen(3 months)
- Hemoglobin(3 months)
- Epworth sleepiness scale(3 months)
- Fasting plasma glucose(3 months)
- Saliva cortisol(3 months)
- Complete blood count(3 months)
- Phosphate level(3 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University