Anti-H. Pylori Effect of Deep See Water
Raktažodžiai
Santrauka
apibūdinimas
Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. Before treatment, H. pylori infection status will be examined by endoscopy with biopsy or 13C-urea breath test (13C-UBT). All patients will receive 13C-UBT before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. A computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say A and B.
group A - ingesting DSW 200 cc four times a day (one hour before meal and bed time); group B - ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
To keep the study in double-blind model, the picture of package for DSW and non-DSW drinking water will be the same.
Prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms.
All patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. Post-treatment, the patients will be seen at the Outpatients Clinic to investigate patient adherence and adverse of treatment.
Datos
| Paskutinį kartą patikrinta: | 04/30/2014 |
| Pirmasis pateikimas: | 08/27/2013 |
| Numatytas registravimas pateiktas: | 08/27/2013 |
| Pirmas paskelbtas: | 09/01/2013 |
| Paskutinis atnaujinimas pateiktas: | 05/11/2014 |
| Paskutinis atnaujinimas paskelbtas: | 05/13/2014 |
| Faktinė studijų pradžios data: | 08/31/2013 |
| Numatoma pirminio užbaigimo data: | 11/30/2013 |
| Numatoma studijų užbaigimo data: | 01/31/2014 |
Būklė ar liga
Intervencija / gydymas
Drug: group A: DSW group
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: group A: DSW group ingesting DSW 200 cc four times a day (one hour before meal and bed time); | Drug: group A: DSW group ingesting DSW 200 cc four times a day (one hour before meal and bed time) |
| Placebo Comparator: group B: non-DSW group ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time). |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 20 Years Į 20 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-H. pylori treatment. Exclusion Criteria: - pregnant or nursing woman - serious concomitant illness and malignant tumor of any kind - serious bleeding from gastrointestinal tract - previous gastric surgery - receiving bismuth salts, Proton pump inhibitors, or antibiotics in the previous month. |
Rezultatas
Pirminės rezultatų priemonės
1. to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen [6 months]
Antrinės rezultatų priemonės
1. to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen [6 months]
