An interventional study of Melatonin and placebo in Melatonin Deficiency, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to female participants aged 49 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Treatment
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.
Background:Dyspeptic syndrome in the form of epigastric pain are particularly frequent in postmenopausal women. 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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 152 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Medical University of Lodz is the lead sponsor of 101 studies on the registry; 9 are open to participants now.
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Patients with
Exclusion Criteria:
Patients with
Melatonin ( 5-Methoxy-N-Acetyltryptamine) at dose 1mg/morning and 3mg/at bedtime (period 6 months)
Drug: Melatonin
1 tablet twice daily (period 6 months)
Other: placebo
Pantoprazole 2 x 40mg (twice daily) Amoxicyllin 2 x 1000mg (twice daily) Lovofloxacin 2 x 500mg (twice daily)
Drug: Pantoprazole 40mg · Drug: Amoxicillin · Drug: Levofloxacin 500mg
pantoprazole 2 x 40mg
Also known as: Pantoprazole
Amoxicillin 2 x 1000mg
Also known as: Amoxycillin
Levofloxacin 2 x 500mg
Also known as: Levofloxacin
10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms
scale that access severity of Dyspeptic symptoms such as: epigastric pain of hunger nature and pain in the epigastric region at night (intensity measured from 1 to 10 points)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz