NCT04300036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

February 24, 2020

Last Update Submit

March 7, 2020

Conditions

Insomnia

Keywords

longaninsomniaefficacysafety

Outcome Measures

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.

    3 months

Secondary Outcomes (21)

  • Thai- The Pittsburgh Sleep Quality Index

    3 months

  • Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire

    3 months

  • Epworth sleepiness scale

    3 months

  • Actiwatch value

    3 months

  • Serum cortisol

    3 months

  • +16 more secondary outcomes

Study Arms (2)

longan syrup

EXPERIMENTAL

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

Dietary Supplement: longan syrup

Placebo syrup

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo syrup

Interventions

longan syrupDIETARY_SUPPLEMENT

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

longan syrup
Placebo syrupDIETARY_SUPPLEMENT

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

Placebo syrup

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, 10310, Thailand

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Pornanong Aramwit, Ph.D

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255aramwit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 9, 2020

Study Start

March 1, 2020

Primary Completion

January 30, 2021

Study Completion

February 10, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)