Efficacy of Melatonin Treatment of Nocturia : a randomized controlled study
Phase 3
Not yet recruiting
- Conditions
- side effect
- Registration Number
- TCTR20200317007
- Lead Sponsor
- Siriraj Routine to research fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method octurnal urination episode in nocturia patients at 2 weeks after end of taking melatonin or placebo Frequency volume chart
- Secondary Outcome Measures
Name Time Method 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