The Study of Combinatory effect of Cydonia oblanga, Cinnamomum zeylanicom, Pistacia lentiscus and Honey in Eradication of Gastric Helicobacter pylori Infection in patients with dyspepsia

The Study of Combinatory effect of fruits of Quince, cinnamon and mastic and Honey in Eradication of Gastric Helicobacter pylori Infection in patients with dyspepsia

Clinical trial of phase 2-3 with control and intervention groups, with parallel groups, double blind, randomized

This study will be performed as a randomized clinical trial on patients over 18 years of age with H. pylori positive referred to the gastrointestinal clinic of Golestan Hospital in Ahvaz. Patients will receive routine daily treatment. These patients will be randomly divided into two groups who will randomly receive a bottle containing placebo or herbal syrup. Unique codes provided by the software will be used on medicine boxes. Symptoms of dyspepsia will be assessed based on a questionnaire before and after the intervention. This questionnaire has 12 questions. These items are scored between 0 and 5 by the subjects

Inclusion criteria: People with one or more symptoms of dyspepsia (based on the Reflux Disease Questionnaire), patients over 18 years of age with a positive H. pylori test, women with a negative pregnancy test. Exclusion criteria: having a chronic disease that leads to long-term use of various drugs, previous history of gastrointestinal ulcers or gastrointestinal bleeding, gastric cancer

Patients are randomly assigned to treatment and control groups. The test and control groups will receive 30 ml of herbal syrup or placebo twice a day for 2 weeks.

Burning sensation in the back of the chest, feeling of pain in the back of the chest, Heartburn, feeling of upper abdominal pain, feeling of acid taste, feeling of movement of the material upwards of the stomach, belching, contusion, cough, difficulty swallowing, bitter taste

The block randomization method is used Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks. The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment, drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual.

Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups

Only part of the data will be shared

The access time is up to 6 months after the results are published

Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis

Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.

Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com

Applicants will have access to the data from the present study by emailing the responsible author for up to one month.golfakhrabadi@yahoo.com