Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

NCT ID: NCT04300036

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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longan syrup

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

Group Type EXPERIMENTAL

longan syrup

Intervention Type DIETARY_SUPPLEMENT

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

Placebo syrup

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

Group Type PLACEBO_COMPARATOR

Placebo syrup

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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longan syrup

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

Intervention Type DIETARY_SUPPLEMENT

Placebo syrup

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pornanong Aramwit, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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

Bangkok, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Pornanong Aramwit, Ph.D

Role: CONTACT

+66899217255

Other Identifiers

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829/62

Identifier Type: -

Identifier Source: org_study_id

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