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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04300036
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Dietary Supplement: longan syrup; Dietary Supplement: Placebo syrup	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Jan 30, 2021
• Anticipated Study Completion Date: Feb 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: longan syrup Take 15 ml of longan syrup once a day for 3 months	Dietary Supplement: longan syrup; Subjects will take 15 ml of longan syrup once a day for 3 months
Placebo Comparator: Placebo syrup Take 15 ml of placebo syrup once a day for 3 months	Dietary Supplement: Placebo syrup; Subjects will take 15 ml of placebo syrup once a day for 3 months

Outcome Measures

Primary Outcome Measures

1. Insomnia severity index [3 months]

   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

1. Thai- The Pittsburgh Sleep Quality Index [3 months]

   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.

2. Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire [3 months]

   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.

3. Epworth sleepiness scale [3 months]

   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.

4. Actiwatch value [3 months]

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

5. Serum cortisol [3 months]

   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.

6. Saliva cortisol [3 months]

   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.

7. Urine Melatonin [3 months]

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

8. Serum Low-density lipoprotein [3 months]

   Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.

9. Serum High-density lipoprotein [3 months]

   Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.

10. Serum total cholesterol [3 months]

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

11. Serum triglyceride [3 months]

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

12. Glycohemoglobin [3 months]

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

13. Fasting plasma glucose [3 months]

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

14. Aspartate aminotransferase in serum [3 months]

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

15. Alanine aminotransferase in serum [3 months]

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

16. Alkaline phosphatase in serum [3 months]

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

17. Serum creatinine [3 months]

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

18. Blood Urea Nitrogen [3 months]

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

19. Hemoglobin [3 months]

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

20. Phosphate level [3 months]

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

21. Complete blood count [3 months]

    Complete blood count (in 10^6 cells/mcl ) after taken longan syrup will not be more than before taken.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok		Thailand	10310

Sponsors and Collaborators

• Chulalongkorn University

Investigators

• Principal Investigator: Pornanong Aramwit, Ph.D, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04300036
• Other Study ID Numbers: 829/62
• First Posted: Mar 9, 2020
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University: longan; insomnia; efficacy; safety
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 10, 2020