Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia (longan)

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 Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Dietary supplement: longan syrup; Dietary supplement: Placebo syrup

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10310
    • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: longan syrup; Take 15 ml of longan syrup once a day for 3 months	Dietary supplement: longan syrup; Subjects will take 15 ml of longan syrup once a day for 3 months
Placebo Comparator: Placebo syrup; Take 15 ml of placebo syrup once a day for 3 months	Dietary supplement: Placebo syrup; Subjects will take 15 ml of placebo syrup once a day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 months
Actiwatch value	Actiwatch value after taken longan syrup will be better than before taken.	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.	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.	3 months
Urine Melatonin	Urine Melatonin overnight (in ng/mL) after taken longan syrup will not be less than before taken.	3 months
Serum Low-density lipoprotein	Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.	3 months
Serum High-density lipoprotein	Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.	3 months
Serum total cholesterol	Serum total cholesterol (in mg/dL) after taken longan syrup will not be more than before taken.	3 months
Serum triglyceride	Serum triglyceride (in mg/dL) after taken longan syrup will not be more than before taken.	3 months
Glycohemoglobin	Glycohemoglobin (Hemoglobin A1c) (in %) after taken longan syrup will not be more than before taken.	3 months
Fasting plasma glucose	Fasting plasma glucose (in mg/dL) after taken longan syrup will not be more than before taken.	3 months
Aspartate aminotransferase in serum	Aspartate aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.	3 months
Alanine aminotransferase in serum	Alanine aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.	3 months
Alkaline phosphatase in serum	Alkaline phosphatase (in U/L ) after taken longan syrup will not be more than before taken.	3 months
Serum creatinine	Serum creatinine (in mg/dl ) after taken longan syrup will not be more than before taken.	3 months
Blood Urea Nitrogen	Blood Urea Nitrogen (in mg/dl ) after taken longan syrup will not be more than before taken.	3 months
Hemoglobin	Hemoglobin (in g/dl ) after taken longan syrup will not be more than before taken.	3 months
Phosphate level	Phosphate level (in g/dl ) after taken longan syrup will not be more than before taken.	3 months
Complete blood count	Complete blood count (in 10^6 cells/mcl ) after taken longan syrup will not be more than before taken.	3 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Ph.D, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): February 10, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: safety; insomnia; efficacy; longan
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 829/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No