Chronic insomnia Sleep disturbance Sleep onset latency Reduced sleep efficiency Daytime sleepiness Sleep fragmentation Cannabidiol CBD Nano-emulsion FLORANBIDIN Chronic insomnia Sleep quality Sleep efficiency Insomnia Severity Index Belun Ring Polysomnography Non-pharmacological sleep aid Piperine Endocannabinoid system Herbal supplement Clinical trial
Conditions
Interventions
Participants in this group will receive FLORANBIDIN containing 50 mg nano-emulsion cannabidiol (CBD-NE) combined with piperine, administered orally once daily at bedtime for 4 weeks.,Participants in t
Experimental Drug,Placebo Comparator Drug
FLORANBIDIN 50 mg,Placebo
Sponsors
National Innovation Agency
CHAKRA Group Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Aged between 18 and 60 years. Diagnosed with chronic insomnia by a physician according to ICSD-3 criteria. Insomnia Severity Index ISI score greater than 15 moderate to severe clinical insomnia. Experiencing insomnia more than 3 times per week for over 3 months. Demonstrated adequate volunteer compliance including possessing a smartphone compatible with the Smart Ring device, ability to communicate with the research team via the LINE application, ability to travel to the hospital for all 4 scheduled visits, and willingness to record sleep data in a sleep diary.
Exclusion criteria
Exclusion criteria: Shift workers Pregnant or breastfeeding women Severe illness or taking medications causing insomnia History of severe obstructive sleep apnea (AHI greater than 30) Received treatment for insomnia including CBT or CNS-acting medications within 3 months before screening International travel across more than 2 time zones within the past 1 month Use of CYP450 inhibitors or inducers affecting cannabinoid metabolism Significant cardiovascular or cerebrovascular disease History of psychiatric disorders within the past 12 months except mild depression or anxiety History of suicide attempts or suicidal ideation Substance or alcohol abuse or dependence within the past 2 years Allergy to cannabis or cannabis extracts Use of cannabis hemp or cannabidiol within the past 3 months Excessive daily caffeine use or inability to abstain from caffeine for more than 24 hours prior to assessments Inability to abstain from alcohol for 24 hours prior to overnight evaluations Medical conditions causing frequent nocturnal awakenings Subjects under mandatory cannabis testing such as workplace drug test or court order Severe liver or kidney impairment as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) score Baseline and week 4 Insomnia Severity Index (ISI) questionnaire, total score comparison between baseline and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total sleep time (TST) Baseline and week 4 Belun Ring and Polysomnography (PSG) assessment, average minutes per night,Change in sleep efficiency (SE) Baseline and week 4 Belun Ring and Polysomnography (PSG), percent of time in bed spent asleep,Change in sleep onset latency (SOL) Baseline and week 4 Belun Ring and Polysomnography (PSG), minutes to fall asleep,Change in wake after sleep onset (WASO) Baseline and week 4 Belun Ring and Polysomnography (PSG), total minutes awake after initial sleep onset,Change in daytime sleepiness Baseline and week 4 Epworth Sleepiness Scale (ESS), total score,Change in sleep quality Baseline and week 4 Pittsburgh Sleep Quality Index (PSQI), total score,Change in quality of life Baseline and week 4 Short Form Health Survey (SF-36), domain scores,Treatment satisfaction Week 4 Treatment Satisfaction Questionnaire for Medication (TSQM), score | — |
Countries
Thailand
Contacts
Public ContactChakrabongse Aiewtrakoon
Health Promotion Hospital Region 9
Outcome results
None listed