Clinical trials: Melatonin
Sleep Hygiene, Sleep Disturbance
Effects of a Novel Supplement on Sleep, Metabolism, Body Composition and Performance
This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, on sleep quality, stress, mood, sleepiness, biological rhythms…
- Trial name
- 4BETTSLEEP (NCT05236504)
- Testing
- Melatonin and magnesium-containing pod
- Where
- Portugal
- Volunteers
- 35 people
- Sponsor
- Bettery S.A.
Alzheimer Disease, Agitation,Psychomotor
Clinical Trial on Agitation in Alzheimer's Dementia
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from…
- Conditions
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS
- Trial name
- CALMA (NCT05543681)
- Testing
- IGC-AD1-Active
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 164 people
- Sponsor
- IGC Pharma, LLC
Sleep
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in…
- Trial name
- NCT06146712
- Testing
- Asutra's 'Dream the night away' nighttime lotion
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Asutra
Sleep Disturbance, Sleep Quality
A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes
This was a single-center, open-label, exploratory self-controlled study evaluating NatureU Sweet Dream on sleep outcomes in adults with mild to moderate sleep disturbance.
- Trial name
- NUSD (NCT07600528)
- Testing
- NatureU Sweet Dream, Commercially Available Melatonin Product
- Where
- China
- Volunteers
- 17 people
- Sponsor
- OmniSolutions Laboratory Holdings Limited
Melatonin Bioavailability
Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects
This study is conducted to clinically document the melatonin and zinc bioavailability of a dietary supplement containing delayed release melatonin, zinc and lemon balm
- Trial name
- NCT05419466
- Testing
- dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Larena SAS
Sleep, Sleep Disturbance
An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in…
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene
- Trial name
- NCT05521243
- Testing
- Beam Organics Dream Powder, Beam Organics Dream Powder Extra Strength
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Beam
Sleep Disorders, Autism Spectrum Disorder
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
- Trial name
- NPC-15-5 (NCT02757066)
- Testing
- NPC-15 Granules Lower Dose, NPC-15 Granules Higher Dose
- Volunteers
- 196 people
- Sponsor
- Nobelpharma
Melatonin Bioavailability
Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
- Trial name
- NCT04574141
- Testing
- a prolonged release tablet and a spray containing melatonin
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- PiLeJe
Opioid Withdrawal, Opioid Use Disorder
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.
- Trial name
- NCT06487533
- Testing
- EmbracePlus Smartwatch, Corti Sensor
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Spark Biomedical, Inc.
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients
KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients.
- Trial name
- NCT02087722
- Testing
- KI1001
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
Infertility, Female, Polycystic Ovary Syndrome
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertilization cycle in patients with…
- Trial name
- NCT04670393
- Testing
- FertyBiotic Woman Plus
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fertypharm
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
- Trial name
- MelatoZincME (NCT05454683)
- Testing
- melatonin plus zinc, isomaltose and magnesium stearate
- Where
- Spain
- Volunteers
- 106 people
- Sponsor
- Laboratorios Viñas, S.A.
Rheumatoid Arthritis
Quality of Sleep in Patients With Rheumatoid Arthritis
As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out.
- Trial name
- NCT00287794
- Testing
- diazepam, melatonin
- Where
- Japan
- Volunteers
- 1,000 people
- Sponsor
- Kobe University
Sleep
Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality.
- Trial name
- NCT07669766
- Testing
- Plant-based melatonin, Melatonin
- Where
- United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Nutraland USA, Inc.
Primary Insomnia
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
- Trial name
- Neu I (NCT00816673)
- Testing
- Circadin
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Breast Cancer, Lung Cancer
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin 1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood alteration in cancer patients
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer
- Trial name
- NCT02883790
- Testing
- Somnage
- Where
- 5 sites in Italy
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Healthy
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
A study comparing the pharmacokinetics of prolonged-release melatonin versus standard, immediate-release melatonin. Multiple blood draws over a 10-hour period will be analysed to determine the area under the curve, time to peak…
- Trial name
- NCT04067791
- Testing
- Prolonged-Release Melatonin, Immediate-Release Melatonin
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pharmavite LLC
Major Depressive Disorder
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
- Trial name
- MAGELLAN (NCT01428661)
- Testing
- tasimelteon
- Where
- 40 sites in United States
- Volunteers
- 507 people
- Sponsor
- Vanda Pharmaceuticals
Postural Instability
Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects
This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.
- Trial name
- NCT01280734
- Testing
- Circadin (R) 2 mg, Stilnox (R) 10 mg
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Neurim Pharmaceuticals Ltd.