Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

Insomnia Clinical Trial

— longan  

Official title:

Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04300036
• Other study ID #: 829/62
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2020
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Ph.D
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 10, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Dietary Supplement:
• longan syrup
Subjects will take 15 ml of longan syrup once a day for 3 months
• Placebo syrup
Subjects will take 15 ml of placebo syrup once a day for 3 months

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

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