side effect side effect
Conditions
Interventions
Take melatonin 1 hour before bedtime daily for 2 weeks
,Take placebo 1 hour before bedtime daily for 2 weeks
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Siriraj Routine to research fund
Siriraj Routine to research fund
Eligibility
Sex/Gender
Female
Age
55 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients who attend Urogynecology unit, Siriraj Hospital with -Nocturia patients (>1 times per night) -Age at least 55 years old -Welcomed participants
Exclusion criteria
Exclusion criteria: Patients with Neurological or psychological abnormalities History of drug allergy or side effects from melatonin Hepatic or renal dysfunction Uncontrolled diabetes mellitus, diabetes insipidus and cardiovascular disease Currently taking diuretic, tranquillizer, hypnotics or melatonin Urinary tract infection or tumor Pelvic organ prolapse at least stage 3 Pelvic organ tumor Urinary retention Currently smoking Taking medication that interact with pharmacokinetics of melatonin including carbamazepine, quinolone, rifampicin, cimetidine, estrogen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal urination episode in nocturia patients at 2 weeks after end of taking melatonin or placebo Frequency volume chart | — |
Secondary
| Measure | Time frame |
|---|---|
| Daytime frequency episode at 2 weeks after end of taking melatonin or placebo Frequency volume chart,Night-time urine volume at 2 weeks after end of taking melatonin or placebo Frequency volume chart,24-hour urine volume at 2 weeks after end of taking melatonin or placebo Frequency volume chart,Maximal voided volume : Daytime and night-time at 2 weeks after end of taking melatonin or placebo Frequency volume chart,Thai version Nocturia Quality of Life Questionnaire score at 2 weeks after end of taking melatonin or placebo Thai version Nocturia Quality of Life Questionnaire,Side effect at 2 weeks after end of taking melatonin or placebo ascertainment | — |
Countries
Thailand
Contacts
Public ContactPimchanok Pariyaeksut
Faculty of Medicine, Siriraj hospital, Mahidol University
Outcome results
None listed