Comparison of the effect of the hydroalcoholic extract of the medicinal plant Xenian (Trachyspermumammi L.), omeprazole and their simultaneous use on the symptoms and quality of life related to the health of patients with gastro-oesophageal reflux.

Determining Comparison of the effect of the hydroalcoholic extract of the medicinal plant Xenian (Trachyspermumammi L.), omeprazole and their simultaneous use on the symptoms and quality of life related to the health of patients with gastro-oesophageal reflux.

Clinical trial, with factorial groups, randomized, phase 3 on 120 patients

Approval of the research plan in the university ethics committee. At the beginning of the study, completion of the checklist of demographic characteristics, reflux symptom index questionnaire and Health-related quality of life - gastroesophageal reflux disease. Intervention in three groups of intervention 1 (Zenian essential oil capsules 150 mg), intervention 2 (Omeprazole capsules 20 mg) and intervention 3 (Zenian essential oil capsules 150 mg and Omeprazole capsules 20 mg at the same time), Once a day for 4 weeks. Immediately after finishing the interventions, re-completion of the reflux symptom index questionnaire and Health-related quality of life - gastroesophageal reflux disease . The place of the intervention is the gastroenterology clinic.

Admission requirements: 1- Age 18-60 2- Consent to participate in the study and sign the informed consent form. Conditions of non-entry: 1- Taking antibiotics or non-steroidal anti-inflammatory drugs 2 weeks before the study 2- Previous participation in studies similar to the current research.

Intervention group 1: Zenian essential oil capsules 150 mg: They use it once a day for 4 weeks. Intervention group 2: Omeprazole capsules 20 mg: It will be used once a day for 4 weeks. Intervention group 3: Zenian essential oil capsules 150 mg and Omeprazole capsules 20 mg at the same time: It will be used once a day for 4 weeks.

Improvement of gastroesophageal reflux symptoms and health-related quality of life

Block random assignment will be done in such a way that according to the number of groups under study (three groups) including intervention 1 (Zenian essential oil capsules 150 mg), intervention 2 (Omeprazole capsules 20 mg) and intervention 3 (Zenian essential oil capsules 150 mg and Omeprazole capsules 20 mg at the same time) and calculated based on the factorial law, i.e. 3 = 1 x 2 x 6 = !3, all the possible arrangements of the subjects considering A for the intervention group 1 (Zenian essential oil capsules 150 mg), B for the intervention group 2 (Omeprazole capsules 20 mg) and C for the intervention group 3 (Zenian essential oil capsules 150 mg and Omeprazole capsules 20 mg at the same time) will be compiled based on the following table: 1 2 3 4 5 6 CBA CAB BCA BAC ACB ABC Then, since the estimated sample size was 120 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done.