Sleep disorder Anxiety disorder Depressive disorder Memory disorder M. rotundifolia Ipomoea aquatica Insomnia Sleep disorder
Conditions
Interventions
herbal formula from M. rotundifolia and Ipomoea aquatica extract 500 mg 1-2 capsule a day at the evening or before bedtime for 28 days.,Microcrystalline cellulose 500 mg 1-2 capsule a day at the eve
herbal formula from M. rotundifolia and Ipomoea aquatica extract,Microcrystalline cellulose medium
Sponsors
National Innovation Agency (Public Organization) (NIA)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Male or female, aged 18-70 years Having sleep problems according to DSM-V criteria A. Having at least one of the following sleep problems: Difficulty falling asleep, taking more than 30 minutes to fall asleep after going to bed. Frequently waking up in the middle of the night after falling asleep. Waking up in the middle of the night or early in the morning and being unable to fall back asleep. B. Insomnia affects daily life, impacts studying or work, or reduces work performance. C. Experiencing insomnia more than 3 nights per week. D. Experiencing insomnia for more than 1 months. E. Experiencing insomnia even when there is an opportunity for adequate rest. F. Unable to explain this insomnia by other sleep disorders. G. This insomnia is not due to drug abuse or medication. H. This insomnia is not due to a mental disorder or medical condition. Understand Thai language
Exclusion criteria
Exclusion criteria: Individuals with a history of allergy to oleamide or rhynchophylline, or components in herbal formulations containing extracts from the morning glory and Mitragyna rotundifolia (Roxb.) Kuntze. Pregnant women, breastfeeding mothers, or those planning to have children within the next 6 months. Individuals diagnosed with sleep apnea. Having severe liver disease or liver function test values (AST, ALT) greater than 3 times the upper limit of normal. Having chronic kidney disease or a kidney function test value (GFR) less than 30 ml/min/1.73 mm. Individuals with a BMI greater than 30, as they may be at risk of developing sleep apnea. Individuals with underlying conditions that the physician assesses may pose a risk if they participate in the study, such as coronary artery disease, schizophrenia, moderate to severe depression, or anxiety disorders requiring current pharmacological treatment, etc. Individuals currently treating insomnia with other methods that do not involve medication, aside from the methods specified in this study. Individuals currently using medications or products that affect sleep (both those that cause drowsiness, such as anxiolytics, antihistamines, hemp products, cannabis, or stimulants that keep them awake or make it difficult to sleep, such as amphetamines, stimulants like caffeine, or energy drinks) within the 7 days prior to starting the study. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Quality Pre dose and at day 7, and day 28 Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue pre-dose, day 7, and day28 Fatigue severity scale,Anxiety and Depression Scale pre-dose, and day28 Hospital Anxiety and Depression Scale (HADS),Memory pre-dose, and day28 Mini-Mental State Examination Thai Version 2002: MMSE-Thai 2022),Depression Pre-dose 9Q,Adverse effect the 1st dose, day 7, day 14, and day 28 Naranjo's Algorithm | — |
Countries
Thailand
Contacts
Public ContactSaithip Suttiruksa
Faculty of Pharmacy, Mahasarakham University
Outcome results
None listed