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IRCT20230131057297N1 IRCT 2023-05-09 Birjand University of Medical Sciences Effects of nanocurcumin in treatment of patients with Helicobacter pylori Investigating the effects of nano curcumin in eradicating and improving the symptoms of patients with Helicobacter pylori infection 2023-06-01 anticipated 80 Complete https://irct.ir/trial/68647 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the current study, sampling will be available from among the eligible and with informed consent. The eligible people will be randomly assigned to one of the two intervention and control groups. First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 80 (two groups of 40) and permuted block randomization method (block size=4) (20 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups, A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will continue until the last sample (80nd person), Blinding description: Patients will not know the type of prescribed medicine, as one group will receive medicine and the other group will receive a placebo. The shape and appearance of the drug and placebo are completely similar to each other. Each patient will receive a code at the beginning of entering the plan, which will indicate the drug that he will receive, and until the end of the study, none of the researchers will know about the drug prescribed for each patient. Also, the person performing the statistical analysis will analyze the patients' information in two groups labeled A and B. 3 Helicobacter pylori infection. Intervention 1: Intervention group: Nanocurcumin capsule 40 mg every 8 hours (Exir Nano Sina Company) + Levofloxacin 500 mg daily + Omeprazole 20 mg every 12 hours + Amoxicillin 1 gr every 12 hours for 14 days. Intervention 2: Control group: Nanocurcumin capsule (placebo) every 8 hours (Exir Nano Sina Company) + levofloxacin 500 mg daily + omeprazole 20 mg every 12 hours + amoxicillin 1 gram every 12 hours for 14 days. 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 -
public Mohammadali mahdiabadi
Ghaffari St
Birjand Iran (Islamic Republic of) 9717964151 +98 56 3162 2035 mahdiabadi_ma@bums.ac.ir Birjand University of Medical Sciences scientific Mohammadali mahdiabadi
Ghaffari St
Birjand Iran (Islamic Republic of) 9717964151 +98 56 3162 2035 mahdiabadi_ma@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Having informed consent to enter the study People aged 18 to 70 years with digestive symptoms such as dyspepsia, nausea, vomiting and epigastric burning Any person who does not have any of the exclusion criteria 18 years 70 years Both History of anti-Helicobacter pylori treatment Taking antibiotics Acute gastrointestinal bleeding Proton pump inhibitor use in the last month Pregnancy or breastfeeding Allergy to turmeric and ginger family Known cancers including stomach People with HIV Recent surgeries Alcohol consumption and the presence of systemic diseases such as cardiovascular diseases and diabetes B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Placebo Intervention group: Nanocurcumin capsule 40 mg every 8 hours (Exir Nano Sina Company) + Levofloxacin 500 mg daily + Omeprazole 20 mg every 12 hours + Amoxicillin 1 gr every 12 hours for 14 days Control group: Nanocurcumin capsule (placebo) every 8 hours (Exir Nano Sina Company) + levofloxacin 500 mg daily + omeprazole 20 mg every 12 hours + amoxicillin 1 gram every 12 hours for 14 days Hong Kong dyspepsia index. Timepoint: before the intervention, immediately after the intervention and one month after the end of the intervention. Method of measurement: Hong Kong dyspepsia index. Helicobacter pylori eradication rate. Timepoint: One month after treatment. Method of measurement: Stool antigen test. Frequency of clinical symptoms (dyspepsia, nausea, vomiting and epigastric burning) in the intervention and placebo groups. Timepoint: The beginning and end of the study. Method of measurement: Questionnaire. Birjand University of Medical Sciences Approved 2022-09-26 Research Ethics Committees of Birjand University of Medical Sciences Ghaffari St Birjand South Khorasan Iran (Islamic Republic of)