Evaluation of cyclodextrin and propolis complex as adjuvant treatment in patients with Helicobacter pylori

Preparation beta-cyclodextrin propolis complex capsules and evaluation role of them as adjuvant therapy in helicobacter pylori infected patients.

Randomized, blinded, parallel group trial, phase 3 on 100 patients.

Patients with symptoms of dyspepsia and a positive biopsy test will go to Tamin Ejtemaei or Atiye Hospitals and after giving informed consent, they will be divided into two treatment and control groups by block randomization. the patient, doctor and student researcher are blinded. The mentioned drug regimens will started for both groups, and after two months, the results are checked with the help of a questionnaire and fecal antigen test in terms of symptom improvement and bacterial eradication.

Inclusion criteria: patients between 18 and 80 years old with symptoms of dyspepsia and a positive Helicobacter biopsy sample. Exclusion criteria: people with duodenal gastrointestinal bleeding, pregnant and lactating women, patients with liver disorders, kidney failure, heart failure and drug sensitivity to any of the studied drugs, patients with a history of Helicobacter pylori therapy, history of alcohol consumption and patients in Current use of NSAIDs and corticosteroids.

Prescribed drugs for both treatment and control groups: bismuth subcitrate 240 mg twice a day, amoxicillin 1 gram twice a day, metronidazole 500 mg twice a day, omeprazole 20 mg once a day for two weeks. In two groups, taking omeprazole will continue for one month. In the treatment group, beta-cyclodextrin and propolis complex 250 mg once a day, and in the control group, a placebo capsule containing starch with the same appearance as the beta-cyclodextrin propolis capsule is given daily for two months will be prescribed.

Improvement of digestive symptoms, eradication of Helicobacter pylori

Eligible patients will be divided into two treatment and control groups by block randomization. The randomization sequence will be in the form of 25 blocks of 4 in which the number of treatments is equal in each block. Blocks will be numbered from one to 25. In a simple random method, using a table of random numbers of blocks, the selection and sequence of treatments in the block will be the basis for assigning patients to treatments. The block randomization sequence is extracted from the following website. https://www.sealedenvelope.com/simple-randomiser/v1/lists

The patient, physician and research student who are responsible for collecting information will not know about the allocation of patients to treatment groups.

Due to the privacy of participants' data