Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
- Conditions
- Insomnia
- Interventions
- Dietary Supplement: Placebo syrupDietary Supplement: longan syrup
- Registration Number
- NCT04300036
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo syrup Placebo syrup Take 15 ml of placebo syrup once a day for 3 months longan syrup longan syrup Take 15 ml of longan syrup once a day for 3 months
- Primary Outcome Measures
Name Time Method Insomnia severity index 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.
- Secondary Outcome Measures
Name Time Method Hemoglobin 3 months Hemoglobin (in g/dl ) after taken longan syrup will not be more than before taken.
Urine Melatonin 3 months Urine Melatonin overnight (in ng/mL) after taken longan syrup will not be less than before taken.
Serum triglyceride 3 months Serum triglyceride (in mg/dL) after taken longan syrup will not be more than before taken.
Glycohemoglobin 3 months Glycohemoglobin (Hemoglobin A1c) (in %) after taken longan syrup will not be more than before taken.
Alanine aminotransferase in serum 3 months Alanine aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Actiwatch value 3 months Actiwatch value after taken longan syrup will be better than before taken.
Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire 3 months Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire (STOP - BANG) after taken longan syrup will not be more than before taken. The minimum and maximum values are 0 and 8 scores, respectively. Higher scores mean a worse outcome.
Thai- The Pittsburgh Sleep Quality Index 3 months Thai- The Pittsburgh Sleep Quality Index after taken longan syrup will be less than before taken. The minimum and maximum values are 0 and 21 scores, respectively. Higher scores mean a worse outcome.
Serum cortisol 3 months Serum cortisol value at 8.00 o'clock (normal value 5-23 mcg/dL) after taken longan syrup will not be less than before taken.
Serum High-density lipoprotein 3 months Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Serum Low-density lipoprotein 3 months Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Serum total cholesterol 3 months Serum total cholesterol (in mg/dL) after taken longan syrup will not be more than before taken.
Aspartate aminotransferase in serum 3 months Aspartate aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Alkaline phosphatase in serum 3 months Alkaline phosphatase (in U/L ) after taken longan syrup will not be more than before taken.
Serum creatinine 3 months Serum creatinine (in mg/dl ) after taken longan syrup will not be more than before taken.
Blood Urea Nitrogen 3 months Blood Urea Nitrogen (in mg/dl ) after taken longan syrup will not be more than before taken.
Epworth sleepiness scale 3 months Epworth sleepiness scale after taken longan syrup will be less than before taken. The minimum and maximum values are 0 and 24 scores, respectively. Higher scores mean a worse outcome.
Fasting plasma glucose 3 months Fasting plasma glucose (in mg/dL) after taken longan syrup will not be more than before taken.
Saliva cortisol 3 months Saliva cortisol at 20.00 o'clock (normal value 3.9 +/- 0.2 nmol/L (range 2.2-4.1 nmol/L)) after taken longan syrup will not be more than before taken.
Complete blood count 3 months Complete blood count (in 10\^6 cells/mcl ) after taken longan syrup will not be more than before taken.
Phosphate level 3 months Phosphate level (in g/dl ) after taken longan syrup will not be more than before taken.
Trial Locations
- Locations (1)
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
🇹ðŸ‡Bangkok, Thailand