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Study aim
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Study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Functional dyspepsia and eradication of H.pylori infection.
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Design
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Study population is the patients that referred to gastroenterology clinic and sample size for study is 60 person. patients are divided into two control and intervention groups by simple randomization and using the Random Allocation software.
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Settings and conduct
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This is a randomized, double-blind clinical trial that is done in gastrointestinal clinic of Shahid Mohammadi Hospial in Bandar Abbas city. In this study, blind persons are participants, clinical caregiver and responsible individual for evaluating the outcome of treatment.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria are written consent, complete knowledge about the study; being diagnosed with functional dyspepsia based on the ROME III criteria and presence of H.pylori infection using Stool Ag test. The exclusion criteria are lack of consent to continue their participation, kidney or liver diseases, warning symptoms of gastric and esophageal cancers, other chronic gastrointestinal diseases and peptic ulcer disease.
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Intervention groups
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The patients of intervention group will be received 3 capsules daily containing the essential oil of the plant for 20 days, and the control group will be received standard treatment Regime for 4 weeks.
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Main outcome variables
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patients of two groups two weeks after the end of treatment will be compared from the point of eradication of H.pylori infection. Patient characteristics such as severity of disease symptoms, and quality of life will enter into a form at the beginning, at the end, and two weeks after completion of treatment. The safety of the treatment regimen is assessed by laboratory tests and through recording adverse drug reactions.