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IRCT20170916036204N7 IRCT 2018-08-08 Shiraz University of Medical Sciences The effect of nigella sativa powder on appetite and appetite hormone in patients with helicobacter pylori The effect of adding nigella sativa powder in addition to conventional medical treatment of helicobacter pylori on plasma ghrelin and appetite in patients with this infection 2017-09-28 anticipated 60 Complete https://irct.ir/trial/27136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with fixed block size of two, Blinding description: The capsules presented to the control group are filled with colored pharmaceutical starch, with the same appearance and packaging as those given to intervention group. So the patients do not recognize which of the two groups they are in. Also, the physician and the data analyst are unaware of this. 4 helicobacter pylori infection. Intervention 1: control group : 4 capsules containing pharmaceutical starch daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori. Intervention 2: intervention group : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hedie Yousefnejad
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 H.YNEJAD@YAHOO.COM Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences scientific Najme Hejazi
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 Nhejazi@sums.ac.ir Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences Iran (Islamic Republic of) positive result of helicobacter pylori infection 18 years 65 years Both Body mass index greater than 30 Having an inflammatory or chronic diseases (kidney disease, liver disease, inflammatory bowel disease, heart ischemia, diabetes, lung disease, asthma, cancer, HIV, systemic inflammation and…) Having history of gastric cancer or gastric surgery Active GI bleeding and intense gastritis Taking any antibiotics or bismuth from 6 weeks before the study Taking all types of medication for helicobacter pylori before the study Pregnancy or lactation at the same time as studying Drinking alcohol or using narcotic at the same time as studying k31.9 Disease of stomach and duodenum, unspecified Placebo Treatment - Other control group : 4 capsules containing pharmaceutical starch daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori intervention group : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori Ghrelin hormone. Timepoint: at the beginning and the end of the study (after 8 weeks ). Method of measurement: ghrelin kit. Appetite. Timepoint: at the beginning and the end of the study. Method of measurement: appetite questionnaire. Shiraz University of Medical Sciences Approved 2017-08-30 Shiraz University of Medical Sciences Iran, Fars,Shiraz,Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)