InsomnialonganNCT04300036
Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
A study testing longan syrup in people with Insomnia, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- longan syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2020to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310
About this study
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.
- Conditions
- Insomnia
- Being tested
- longan syrup, Placebo syrup
- Keywords
- longan, insomnia, efficacy, safety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
longan syrupDietary supplement
Subjects will take 15 ml of longan syrup once a day for 3 months
Placebo syrupDietary supplement
Subjects will take 15 ml of placebo syrup once a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| longan syrup | Experimental | Take 15 ml of longan syrup once a day for 3 months Receives: Dietary Supplement: longan syrup |
| Placebo syrup | Placebo comparator | Take 15 ml of placebo syrup once a day for 3 months Receives: Dietary Supplement: Placebo syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (21)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Actiwatch value
Actiwatch value after taken longan syrup will be better than before taken.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Urine Melatonin
Urine Melatonin overnight (in ng/mL) after taken longan syrup will not be less than before taken.
Measured: 3 months
Serum Low-density lipoprotein
Serum Low-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Measured: 3 months
Serum High-density lipoprotein
Serum High-density lipoprotein (in mg/dL) after taken longan syrup will not be more than before taken.
Measured: 3 months
Serum total cholesterol
Serum total cholesterol (in mg/dL) after taken longan syrup will not be more than before taken.
Measured: 3 months
Serum triglyceride
Serum triglyceride (in mg/dL) after taken longan syrup will not be more than before taken.
Measured: 3 months
Glycohemoglobin
Glycohemoglobin (Hemoglobin A1c) (in %) after taken longan syrup will not be more than before taken.
Measured: 3 months
Fasting plasma glucose
Fasting plasma glucose (in mg/dL) after taken longan syrup will not be more than before taken.
Measured: 3 months
Aspartate aminotransferase in serum
Aspartate aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Alanine aminotransferase in serum
Alanine aminotransferase (in U/L ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Alkaline phosphatase in serum
Alkaline phosphatase (in U/L ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Serum creatinine
Serum creatinine (in mg/dl ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Blood Urea Nitrogen
Blood Urea Nitrogen (in mg/dl ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Hemoglobin
Hemoglobin (in g/dl ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Phosphate level
Phosphate level (in g/dl ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Complete blood count
Complete blood count (in 10^6 cells/mcl ) after taken longan syrup will not be more than before taken.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion10 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Ph.D, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300036
- Sponsor's protocol ID
- 829/62
- Acronym
- longan
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia
- ClinicalTrials.gov ID
- NCT04300036
- Acronym / sponsor ID
- longan / 829/62
- Conditions
- Insomnia
- Keywords
- longan, insomnia, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 10 Feb 2021 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| longan syrup | Experimental | Dietary Supplement: longan syrupTake 15 ml of longan syrup once a day for 3 months |
| Placebo syrup | Placebo comparator | Dietary Supplement: Placebo syrupTake 15 ml of placebo syrup once a day for 3 months |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| longan syrupSubjects will take 15 ml of longan syrup once a day for 3 months | Dietary supplement | longan syrup |
| Placebo syrupSubjects will take 15 ml of placebo syrup once a day for 3 months | Dietary supplement | Placebo syrup |
Primary outcome
Insomnia severity index
Time frame: 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.
21 secondary outcomes
Thai- The Pittsburgh Sleep Quality Index
Time frame: 3 months
Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender questionaire
Time frame: 3 months
Epworth sleepiness scale
Time frame: 3 months
Actiwatch value
Time frame: 3 months
Serum cortisol
Time frame: 3 months
Saliva cortisol
Time frame: 3 months
Urine Melatonin
Time frame: 3 months
Serum Low-density lipoprotein
Time frame: 3 months
Serum High-density lipoprotein
Time frame: 3 months
Serum total cholesterol
Time frame: 3 months
Serum triglyceride
Time frame: 3 months
Glycohemoglobin
Time frame: 3 months
Fasting plasma glucose
Time frame: 3 months
Aspartate aminotransferase in serum
Time frame: 3 months
Alanine aminotransferase in serum
Time frame: 3 months
Alkaline phosphatase in serum
Time frame: 3 months
Serum creatinine
Time frame: 3 months
Blood Urea Nitrogen
Time frame: 3 months
Hemoglobin
Time frame: 3 months
Phosphate level
Time frame: 3 months
Complete blood count
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornanong Aramwit, Ph.D principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing longan syrup in people with Insomnia, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Ph.D (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.