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

Chulalongkorn University

Status: Unknown

Conditions: Insomnia

Treatments: Dietary Supplement: Placebo syrup; Dietary Supplement: longan syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT04300036

829/62

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

longan syrup

Experimental group

Description:

Take 15 ml of longan syrup once a day for 3 months

Treatment:

Dietary Supplement: longan syrup

Placebo syrup

Placebo Comparator group

Description:

Take 15 ml of placebo syrup once a day for 3 months

Treatment:

Dietary Supplement: Placebo syrup