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Study aim
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Comparison of Plantago major seed with placebo on GI symptoms in patients
with erosive gastritis or erosive duodenitis
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Design
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This study is a randomly-based phase3 clinical trial. 64 patients with erosive gastroduodenitis , which refer to the hospital of Rasoul Akram and the doctor's office, are randomly divided into two groups of intervention and control.
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Settings and conduct
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This study is done in double-blind way and contributors and clinicians are not aware of the drug. Patients referring to the Rasoul Akram hospital and the doctor's office ,64 people, are included in the study by entering conditions. Participants are randomly assigned to two intervention groups (32 people) and placebo (32 people). At first, 10 of each group were studied at pilot study.
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Participants/Inclusion and exclusion criteria
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Major inclusion criteria include: age of 20 to 60 years, those diagnosed erosive gastroduodenitis by endoscopy ، negative test of Helicobacter pylori .
Exclusion criteria are: pregnancy and lactation , cardiovascular disease, epilepsy , using anticoagulant medications, using a research drug in the past 30 days, any factor to reduce patient compliance and tolerance, such as alcohol and drug abuse, The existence of a severe illness that make performing endoscopy for them dangerous , severe bleeding , Malignancy,blood Coagulation Disorders , Zollinger Ellison syndrome , lung disease
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Intervention groups
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Intervention group (Plantago major seeds capsule): Members of the intervention group, twice a day, each time receiving two capsules of Plantago major seeds and 1 Pantoprazole 40 mg For 4 weeks
placebo group (bread powder): members of this group, twice a day, each time 2 placebo capsules and 1 Pantoprazole 40mg for 4 weeks.
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Main outcome variables
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1- Severity of digestive symptoms 2- Frequency of digestive symptoms in the week