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IRCT2014062212789N4 IRCT 2014-10-06 Vice Chancellor for Research, Kurdistan University of Medical Sciences Effect of zinc sulphate on peptic and jejunal ulcer A clinical trial to compare the effect of high dose zinc sulphate and placebo on ulcer size of patients with peptic and jejunal ulcer 2014-07-06 anticipated 90 Complete https://irct.ir/trial/12793 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: If RUT test is positive triple therapy including amoxicillin, clarithromycin, omeprazole is prescribed for two weeks. According to ulcer size (greater than or equal to three centimeters or smaller than three centimeters) treatment time is determined. This way if the wound size is greater than or equal to three centimeters treatment with triple therapy for 2 weeks will be done and will be followed 4 weeks of treatment with omeprazole. If the wound size is smaller than 2 centimeters treatment with triple therapy for 2 weeks will be done and will be followed 2 weeks of treatment with omeprazole. If RUT test is negative treatment just with omeprazole for 2 weeks is performed. Considering that in the case of ulcers in patients with gastrointestinal bleeding or in the case of PPI or antibiotic use in the last 2 weeks RUT answer may be false negative so in these cases gG H.PYLORI AB-I will be checked. If RUT is positive they will be treated as RUT positive and if RUT is negative they will be treated as RUT negative. Those who are in the intervention group in addition to triple therapy, zinc sulfate 220 mg capsules (Alhavi pharmaceutical company) will be given daily. And the people who are in the control group zinc sulfate 220 mg capsules will not be given. N/A Peptic ulcer. Intervention 1: In addition to triple therapy, Zinc sulfate 220 mg capsules (Alhavi pharmaceutical company) will be given to people who are in the intervention group daily. Intervention 2: The control group received placebo capsules in addition to triple therapy.
public Morteza Nayebi
Basij Sq., Geryashan St.,Tohid Hospital
Sanandaj Iran (Islamic Republic of) +98 87 3366 4654 mortazanayebi55@yahoo.com Kurdistan University of Medical Sciences scientific Dr Kambiz Yazdanpanah
Pasdaran St., Kurdistan University of Medical Sciences
Sananadaj Iran (Islamic Republic of) +98 87 3366 4651 KYAZDAN4@YAHOO.COM Kurdistan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: presence of peptic ulcer during endoscopy Exclusion criteria: presence of clear symptoms indicating malignancy in observation, presence of malignancy in pathology, patient reluctance to endoscopy, unwillingness to continuing to use the drug, drug discontinuation more than two days, diseases that impair absorption ( cirrhosis, celiac disease). 16 years 85 years Both K27 Peptic ulcer, site unspecified Treatment - Drugs Treatment - Drugs In addition to triple therapy, Zinc sulfate 220 mg capsules (Alhavi pharmaceutical company) will be given to people who are in the intervention group daily. The control group received placebo capsules in addition to triple therapy. Ulcer size. Timepoint: 6 weeks after initial endoscopy. Method of measurement: The ulcer would be determined by sub-specialist of gastroenterology via endoscopy. Complications. Timepoint: During the study and 8 weeks after the initial endoscopy. Method of measurement: Observation and examination by Subspecialist of Gastroenterology. Ulcer place. Timepoint: During the initial endoscopy. Method of measurement: Based on the location of ulcer was determined by gastroenterologist via endoscopy: stomach, antrum, fundus, cardia and duodenum. Diarrhea and vomiting. Timepoint: During the study. Method of measurement: Observation and examination by specialist. Dizziness. Timepoint: During the study. Method of measurement: Observation and examination by specialist. Vice Chancellor for Research, Kurdistan University of Medical Sciences Approved 2014-03-05 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran St., Kurdistan University of Medical Sciences Sanandaj Iran (Islamic Republic of)