Investigating the effects of nano curcumin in eradicating and improving the symptoms of patients with Helicobacter pylori infection

Determining the effects of nano curcumin in eradicating and improving the symptoms of patients with Helicobacter pylori infection

Clinical trial with control group, with parallel groups, three blind, randomized

patients with H. pylori infection who referred to the gastroenterology clinic of birjand Vali-e-Asr Hospital during 1401-1402.

Inclusion criteria: 1- Having informed consent to enter the study 2- People aged 18 to 70 with digestive symptoms such as dyspepsia, nausea, vomiting and epigastric burning suspected of Helicobacter pylori, who will refer to the specialized gastroenterology clinic of Vali-e-Asr Hospital in Birjand. 3-Any person who does not meet any of the exclusion criteria will be included in the study if they are satisfied Exclusion criteria: 1- History of anti-H.pylori treatment 2- Antibiotic use 3- Acute gastrointestinal bleeding 4- Proton pump inhibitor use in the last month 5- Pregnancy or breastfeeding 6- Allergy to turmeric and ginger family 7- Known cancers including stomach 8- People with HIV 9- Recent surgeries 10- Alcohol consumption and the presence of systemic diseases such as cardiovascular diseases and diabetes

the nano curcumin capsule is given to the intervention group every eight hours for 14 days in addition to the Helicobacter pylori treatment, and the Plasio capsule is given to the control group every eight hours along with the Helicobacter pylori treatment.

Hong Kong dyspepsia index; Helicobacter pylori eradication rate

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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).

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.