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Status unknownNCT04300036longanUpdated Mar 10, 2020

Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

An interventional study of longan syrup and Placebo syrup in Insomnia, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia

Keywords

  • longan
  • insomnia
  • efficacy
  • safety
03

In context

Sleep Initiation and Maintenance Disorders

1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.

This study's planned enrollment of 50 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    longan syrup

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

    Dietary Supplement: longan syrup

  • Placebo comparator
    Placebo syrup

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

    Dietary Supplement: Placebo syrup

Interventions

  • Dietary supplementlongan syrup

    Subjects will take 15 ml of longan syrup once a day for 3 months

  • Dietary supplementPlacebo syrup

    Subjects will take 15 ml of placebo syrup once a day for 3 months

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. Actiwatch value

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

    Time frame: 3 months

  5. 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

  6. 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

  7. Urine Melatonin

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

    Time frame: 3 months

  8. 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

  9. 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

  10. Serum total cholesterol

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

    Time frame: 3 months

  11. Serum triglyceride

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

    Time frame: 3 months

  12. Glycohemoglobin

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

    Time frame: 3 months

  13. Fasting plasma glucose

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

    Time frame: 3 months

  14. Aspartate aminotransferase in serum

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

    Time frame: 3 months

  15. Alanine aminotransferase in serum

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

    Time frame: 3 months

  16. Alkaline phosphatase in serum

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

    Time frame: 3 months

  17. Serum creatinine

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

    Time frame: 3 months

  18. Blood Urea Nitrogen

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

    Time frame: 3 months

  19. Hemoglobin

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

    Time frame: 3 months

  20. Phosphate level

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

    Time frame: 3 months

  21. 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

07

Study locations

1 site
  • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
    Bangkok, 10310, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04300036
Lead sponsor
Chulalongkorn University
Responsible party
Pornanong Aramwit, Pharm.D., Ph.D (Professor, Chulalongkorn University) — Principal investigator
First posted
Mar 9, 2020
Start date
Mar 1, 2020 (estimated)
Primary completion
Jan 30, 2021 (estimated)
Completion
Feb 10, 2021 (estimated)
Last update
Mar 10, 2020

Study contacts

Pornanong Aramwit, Ph.D
Contact
aramwit@gmail.com
+66899217255
Pornanong Aramwit, Ph.D
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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