Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

Chulalongkorn University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Insomnia

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Insomnia severity index

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.

Time frame: 3 months

Secondary Outcomes

Thai- The Pittsburgh Sleep Quality Index

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.

Time frame: 3 months

Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire

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.

Time frame: 3 months

Epworth sleepiness scale

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.

Time frame: 3 months

Actiwatch value

Actiwatch value after taken longan syrup will be better than before taken.

Time frame: 3 months

Serum cortisol

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.

Time frame: 3 months

Saliva cortisol

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.

Time frame: 3 months

Urine Melatonin

Urine Melatonin overnight (in ng/mL) after taken longan syrup will not be less than before taken.

Time frame: 3 months

Serum Low-density lipoprotein

Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Serum High-density lipoprotein

Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Serum total cholesterol

Serum total cholesterol (in mg/dL) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Serum triglyceride

Serum triglyceride (in mg/dL) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Glycohemoglobin

Glycohemoglobin (Hemoglobin A1c) (in %) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Fasting plasma glucose

Fasting plasma glucose (in mg/dL) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Aspartate aminotransferase in serum

Aspartate aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Alanine aminotransferase in serum

Alanine aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Alkaline phosphatase in serum

Alkaline phosphatase (in U/L ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Serum creatinine

Serum creatinine (in mg/dl ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Blood Urea Nitrogen

Blood Urea Nitrogen (in mg/dl ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Hemoglobin

Hemoglobin (in g/dl ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Phosphate level

Phosphate level (in g/dl ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Complete blood count

Complete blood count (in 10\^6 cells/mcl ) after taken longan syrup will not be more than before taken.

Time frame: 3 months

Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts