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IRCT2017091636204N1 IRCT 2017-10-16 Shiraz University of Medical Sciences Comparing the effect of nigella sativa powder and cuminum cyminum powder on eradication of helicobacter pylori, dyspepsia and quality of life in patients with this infection Comparing the effect of nigella sativa powder and cuminum cyminum powder in addition to conventional medical treatment of helicobacter pylori on eradication of bacteria , inflammatory and oxidative stress markers, dyspepsia and quality of life in patients with this infection 2017-10-02 anticipated 90 Complete https://irct.ir/trial/27133 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Dyspepsia. Condition 2: Helicobacter pylori infection. Intervention 1: control group : 4 capsules containing pharmaceutical starch daily for 8 weeks. Intervention 2: intervention group 1 : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks. Intervention 3: intervention group 2 : 4 capsules of 500 mg containing cuminum cyminum powder daily for 8 weeks.
public Hedie Yousefnejad
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) +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) +98 71 3725 1001 Nhejazi@sums.ac.ir Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: People who have any of the following conditions can participate in the study: 1. Having positive result of helicobacter pylori infection and dyspepsia symptoms 2. Having positive result of helicobacter pylori infection and dyspepsia symptoms with mild to moderate peptic ulcer 3. Having positive result of helicobacter pylori infection and dyspepsia symptoms with mild to moderate gastritis Exclusion criteria: 1. Having a history of gastric cancer or gastric surgery 2. Active GI bleeding and intense gastritis 3. Having an inflammatory or chronic disease (kidney disease, liver disease, inflammatory bowel disease, heart ischemia, diabetes, lung disease, asthma, cancer, HIV, systemic inflammation and…) 4. Taking any antibiotics or bismuth from 6 weeks before the study 5. Taking all types of medication for helicobacter pylori before the study 6. Pregnancy or lactation at the same time as studying 7. Drinking alcohol or using narcotic at the same time as studying 8. Eating a specific diet (vegetarian diet and …) at the same time as studying 9. Body mass index greater than 30 10. Exiting patient during the study 11. Any changes in the use of anti-inflammatory drugs and corticosteroids at the same time as studying 12. Any changes in the use of supplements such as omega 3, selenium, zinc, beta carotene, vitamin E, C and… at the same time as studying 13. Unwillingness to continue the study 18 years 65 years Both K30 K31.9 Dyspepsia Disease of stomach and duodenum, unspecified Placebo Treatment - Other Treatment - Other control group : 4 capsules containing pharmaceutical starch daily for 8 weeks intervention group 1 : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks intervention group 2 : 4 capsules of 500 mg containing cuminum cyminum powder daily for 8 weeks HsCRP. Timepoint: at the beginning and the end of the study ( after 8 weeks ). Method of measurement: hsCRP kit. Eradication percentage of helicobacter pylori. Timepoint: at the end of the study. Method of measurement: stool antigen test of helicobacter pylori. Malondialdehyde. Timepoint: at the beginning and the end of the study. Method of measurement: malondialdehyde kit. Interleukin 8. Timepoint: at the beginning and the end of the study. Method of measurement: interleukin 8 kit. Quality of life. Timepoint: at the beginning and the end of the study. Method of measurement: sf-36 questionnaire. Dyspepsia symptoms. Timepoint: at the beginning and the end of the study. Method of measurement: ROMEIII questionnaire. Shiraz University of Medical Sciences Approved 2017-07-19 Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd. Shiraz Iran (Islamic Republic of)