Clinical trial NCT04300036: Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
Official title: Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: longan
insomnia
efficacy
safety
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity index
timeFrame: 3 months
Secondary outcomes:
measure: Thai- The Pittsburgh Sleep Quality Index
timeFrame: 3 months
measure: Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire
timeFrame: 3 months
measure: Epworth sleepiness scale
timeFrame: 3 months
measure: Actiwatch value
timeFrame: 3 months
measure: Serum cortisol
timeFrame: 3 months
measure: Saliva cortisol
timeFrame: 3 months
measure: Urine Melatonin
timeFrame: 3 months
measure: Serum Low-density lipoprotein
timeFrame: 3 months
measure: Serum High-density lipoprotein
timeFrame: 3 months
measure: Serum total cholesterol
timeFrame: 3 months
measure: Serum triglyceride
timeFrame: 3 months
measure: Glycohemoglobin
timeFrame: 3 months
measure: Fasting plasma glucose
timeFrame: 3 months
measure: Aspartate aminotransferase in serum
timeFrame: 3 months
measure: Alanine aminotransferase in serum
timeFrame: 3 months
measure: Alkaline phosphatase in serum
timeFrame: 3 months
measure: Serum creatinine
timeFrame: 3 months
measure: Blood Urea Nitrogen
timeFrame: 3 months
measure: Hemoglobin
timeFrame: 3 months
measure: Phosphate level
timeFrame: 3 months
measure: Complete blood count
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: