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IRCT20220619055216N1 IRCT 2022-11-13 Yasouj University of Medical Sciences Investigating the effect of herbal medicineTrachyspermumammi L on the symptoms of gastro-oesophageal reflux 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. 2022-10-23 anticipated 120 Complete https://irct.ir/trial/64656 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: 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. 3 Patients with gastroesophageal reflux. Intervention 1: Intervention group 1: Zenian essential oil capsules 150 mg: They use it once a day for 4 weeks. Zenian essential oil is produced in Kashan essential oil Barich pharmaceutical company. In order to determine the safe dose and prepare herbal soft gel capsules according to the available sources, the maximum dose of essential oils studied in medicinal plants in humans for daily oral consumption for Zenian is equal to 500 mg. To prepare the ethanolic extract, the plant sample (Zenian seeds) was dried in the shade (room temperature) after collection. After it was ensured that the seeds were completely dried, they were powdered by a mill, then to prepare the ethanolic extract, 100 grams of the dried powder was mixed with 500 cc of 70% ethanol and kept for 48 hours at room temperature and in the dark (22 °C) is kept. Then, the obtained extract was filtered by filter paper and 70% alcohol solution was added to it again for another 24 hours and kept in the same conditions as before. After this time, it was filtered again by filter paper and the solution was put into a rotary evaporator at a speed of 100 revolutions per minute to remove alcohol, and finally the said solution was dried at 40 degrees Celsius in an incubator. Intervention 2: Intervention group 2: Omeprazole capsules 20 mg: It will be used once a day for 4 weeks. Intervention 3: 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. 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 NO more information
public Ehsan Elahinia
Luqman St, Adl Square, Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
Yasuj Iran (Islamic Republic of) 7591111789 +98 74 3322 7573 elahie@93gmail.com Yasouj University of Medical Sciences scientific Ehsan Elahinia
Luqman St, Adl Square, Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3322 7573 elahie93@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Being 18-60 years old Consent to participate in the study and sign the informed consent form Diagnosing gastroesophageal reflux by gastroenterologist based on ROME lll criteria Body mass index (BMI) less than 30 (BMI>30) Absence of systemic diseases Absence of neurological defects 18 years 60 years Both Taking antibiotics or non-steroidal anti-inflammatory drugs 2 weeks before the study Previous participation in studies similar to the current research Drug or alcohol abuse Existence of gastrointestinal malignancy based on history, physical examination, laboratory tests (for example, the number of white blood cells, CRP, ESR, and upper endoscopy) Liver and kidney function disorders based on laboratory tests Pregnancy History of severe allergy to medicinal plants History of upper gastrointestinal surgery and serious diseases such as heart failure, diabetes, epilepsy, previous or current significant psychiatric disorders K21 Gastro-esophageal reflux disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Zenian essential oil capsules 150 mg: They use it once a day for 4 weeks. Zenian essential oil is produced in Kashan essential oil Barich pharmaceutical company. In order to determine the safe dose and prepare herbal soft gel capsules according to the available sources, the maximum dose of essential oils studied in medicinal plants in humans for daily oral consumption for Zenian is equal to 500 mg. To prepare the ethanolic extract, the plant sample (Zenian seeds) was dried in the shade (room temperature) after collection. After it was ensured that the seeds were completely dried, they were powdered by a mill, then to prepare the ethanolic extract, 100 grams of the dried powder was mixed with 500 cc of 70% ethanol and kept for 48 hours at room temperature and in the dark (22 °C) is kept. Then, the obtained extract was filtered by filter paper and 70% alcohol solution was added to it again for another 24 hours and kept in the same conditions as before. After this time, it was filtered again by filter paper and the solution was put into a rotary evaporator at a speed of 100 revolutions per minute to remove alcohol, and finally the said solution was dried at 40 degrees Celsius in an incubator. 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. Reflux Symptom Index. Timepoint: Before and after the intervention. Method of measurement: reflux symptom index questionnaire. Health-related quality of life - gastroesophageal reflux disease (GERD-HRQL. Timepoint: Before and after the intervention. Method of measurement: Health-related quality of life - gastroesophageal reflux disease (GERD-HRQL). Yasouj University of Medical Sciences Approved 2022-03-20 Ethics Committee of Yasouj University of Medical Sciences Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)