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

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
longan syrup
Placebo syrup
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring longan, insomnia, efficacy, safety

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

longan syrup

Placebo syrup

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2020
Last Updated
March 7, 2020
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04300036
Brief Title
Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
Acronym
longan
Official Title
Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
February 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
longan, insomnia, efficacy, safety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
longan syrup
Arm Type
Experimental
Arm Description
Take 15 ml of longan syrup once a day for 3 months
Arm Title
Placebo syrup
Arm Type
Placebo Comparator
Arm Description
Take 15 ml of placebo syrup once a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
longan syrup
Intervention Description
Subjects will take 15 ml of longan syrup once a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo syrup
Intervention Description
Subjects will take 15 ml of placebo syrup once a day for 3 months
Primary Outcome Measure Information:
Title
Insomnia severity index
Description
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 Outcome Measure Information:
Title
Thai- The Pittsburgh Sleep Quality Index
Description
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
Title
Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire
Description
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
Title
Epworth sleepiness scale
Description
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
Title
Actiwatch value
Description
Actiwatch value after taken longan syrup will be better than before taken.
Time Frame
3 months
Title
Serum cortisol
Description
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
Title
Saliva cortisol
Description
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
Title
Urine Melatonin
Description
Urine Melatonin overnight (in ng/mL) after taken longan syrup will not be less than before taken.
Time Frame
3 months
Title
Serum Low-density lipoprotein
Description
Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Serum High-density lipoprotein
Description
Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Serum total cholesterol
Description
Serum total cholesterol (in mg/dL) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Serum triglyceride
Description
Serum triglyceride (in mg/dL) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Glycohemoglobin
Description
Glycohemoglobin (Hemoglobin A1c) (in %) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Fasting plasma glucose
Description
Fasting plasma glucose (in mg/dL) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Aspartate aminotransferase in serum
Description
Aspartate aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Alanine aminotransferase in serum
Description
Alanine aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Alkaline phosphatase in serum
Description
Alkaline phosphatase (in U/L ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Serum creatinine
Description
Serum creatinine (in mg/dl ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Blood Urea Nitrogen
Description
Blood Urea Nitrogen (in mg/dl ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Hemoglobin
Description
Hemoglobin (in g/dl ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Phosphate level
Description
Phosphate level (in g/dl ) after taken longan syrup will not be more than before taken.
Time Frame
3 months
Title
Complete blood count
Description
Complete blood count (in 10^6 cells/mcl ) after taken longan syrup will not be more than before taken.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
City
Bangkok
ZIP/Postal Code
10310
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

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