drugset / Trial / NCT04352062

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

NCT04352062

Completed 152 enrolled Medical University of Lodz
RandomizedParallel-groupSingle-blindTreatment

Summary

Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of Helicobacter infection. Methods: The study comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

Timeline

Start
2011-01-09
Primary completion
2018-10-26
Completion
2018-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 1 mg
Subject Melatonin Small molecule 3 mg
Background Amoxicillin Other / unclassified 1000 mg
Background Levofloxacin Small molecule 500 mg
Background Pantoprazole Other / unclassified 40 mg

Indications

No indication recorded.