Insomnia Insomnia, sleep disorders
Conditions
Interventions
Dillenia extract 500 mg/capsule (containing 0.7 mg of oleamide per capsule),Placebo
Dillenia extract,Placebo
Sponsors
National Innovation Agency (NIA) and Sciseeit.Co, Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female with age from 18 to 70 years old 2. Participants who diagnosed as insomnia by DSM-V assessment criteria. 3. Patients who understand Thai language and be able to communicate with the research teams 4. Participants who willing to participate the study
Exclusion criteria
Exclusion criteria: 1. Participants who experienced allergy to oleamide, Dillenia extract or other ingredients of the product. 2. Pregnant or breastfeeding woman 3. Patients who had an obstructive sleep apnea: OSA. 4. Participant with abnormal liver function (AST, ALT > 3 times higher than normal). 5. Participants with chronic kidney disease or acute kidney injury (GFR < 30 ml/min/1.73m2). 6. Prticipant with BMI more than 30 (which is a risk to occur an OSA). 7. Participants with other underlying diseases or medical problems that would interfere with the study such as a heart disease, schizophrenia, moderate to severe depression or anxiety that required treatment with other medications 8. Participant who treating insomnia with other methods beside those prescribed in this study. 9. Patients who are using medications or products that affect sleep quality (such as antianxiety, antihistamine, hemp, marijuana, amphetamine, stimulant, beta-blockers, steroids, theophylline etc.) 14 days before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality 4 weeks Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of sleep and severity of insomnia 2 and 4 weeks PSQI, Sleep onset latency (SOL), Wake after sleep onset (WASO), Sleep efficiency (SE), Insomnia Severity Index, and Fatigue severity scale,sleep test 4 weeks % of Sleep stage (N1, N2, N3, REM), Number of awakening, number of patients who have recovered from insomnia, and Total Sleep Time (TST),Anxiety and depression week 4 Hospital Anxiety and Depression Scale (HADS),Dementia outcome Week4 Mini-Mental State Examination Thai Version 2002: MMSE-Thai 2022),safety outcome week 1, 2 and 4 Adverse drug reactions, adverse effect | — |
Countries
Thailand
Contacts
Public ContactRatree Sawangjit
Faculty of Pharmacy, Mahasarakham University
Outcome results
None listed