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IRCT20200424047192N1 IRCT 2021-01-24 Gorgan University of Medical Sciences The effect of eating and drinking modification and sumac in the treatment of dyspepsia Comparative study of the effect of eating and drinking modification and sumac capsule with omeprazole on functional dyspepsia symptoms in adults 2021-01-04 anticipated 104 Complete https://irct.ir/trial/47931 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to one of the following four groups based on a random allocation with octet-blocks previously generated by the Statistics and Methodology Consultant: A- Treatment with eating and drinking modification + sumac capsules B- Treatment with eating and drinking modification C- Treatment with sumac capsules D- Treatment with omeprazole capsules In this study, the number of octet- blocks will be 13. These blocks have 4 letters and each letter has two repetitions. For example, four octet-blocks could be as follows: DCBCDABA, CDBACDAB, ABBCDADC, BACADBCD Accordingly, the first person who enter the study will be assigned to group D, ie treatment with omeprazole capsules, the second person to group C, ie treatment with sumac capsule, and In the same way, assigning participants to study groups up to the last person will be done based on the letters of pre-made blocks. 3 Functional dyspepsia. Intervention 1: First intervention group: observing eating and drinking modification + one capsule of sumac extract after each meal (three times a day). At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior. In addition, patients in this group will receive 42 capsules of sumac extract on the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way. Intervention 2: Second intervention group: observing eating and drinking modification. At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior. Intervention 3: Third intervention group: one capsule of sumac extract after each meal (three times a day). Patients in this group will receive 42 capsules of sumac extract in the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way. Intervention 4: Control group: one omeprazole capsule before breakfast (once a day). Patients in this group will receive 14 capsules of 20 mg omeprazole in the first visit (day zero), which will be taken one capsule per day before breakfast. In the second visit, which will be done two weeks after the start of the study, 14 capsules of 20 mg omeprazole will be delivered to them for consumption in the same way. 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 Its release schedule is not yet known
public Mahdi Saravani
Gorgan university of medical science ,Hirkan blve
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1653 dr.msaravani91@gmail.com Gorgan University of Medical Sciences scientific Mahdi Saravani
Gorgan university of medical science ,Hirkan blve
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1653 dr.msaravani91@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Patient age range between 18 and 60 years Detection of functional dyspepsia (based on ROME III criteria) Existence of normal endoscopy without specific pathological findings The onset of symptoms is at least 6 months in advance and the presence of symptoms at least 3 days a week in the last three months Absence of Helicobacter pylori infection No history of treatment with antibiotics and PPIs during the last 1 month 18 years 60 years Both Underlying diseases including heart failure; renal and hepatic failure; dirrhosis; diabetes, thyroid disorders Smoking, drug or alcohol use Consumption NSAIDs or aspirin Pregnancy or breastfeeding K30 Functional dyspepsia Treatment - Drugs Lifestyle Treatment - Drugs Treatment - Drugs First intervention group: observing eating and drinking modification + one capsule of sumac extract after each meal (three times a day). At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior. In addition, patients in this group will receive 42 capsules of sumac extract on the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way. Second intervention group: observing eating and drinking modification. At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior. Third intervention group: one capsule of sumac extract after each meal (three times a day). Patients in this group will receive 42 capsules of sumac extract in the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way. Control group: one omeprazole capsule before breakfast (once a day). Patients in this group will receive 14 capsules of 20 mg omeprazole in the first visit (day zero), which will be taken one capsule per day before breakfast. In the second visit, which will be done two weeks after the start of the study, 14 capsules of 20 mg omeprazole will be delivered to them for consumption in the same way. Total score of gastrointestinal symptom rating scale. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Quality of Life. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: 10‐item short form of Nepean Dyspepsia Index (NDI-10). Eating and drinking habits. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: Eating and drinking habits questionnaire. Drug side effects. Timepoint: During the intervention and up to one month after the end of the intervention. Method of measurement: Drug side effects questionnaire. Gorgan University of Medical Sciences Approved 2020-12-20 Ethics committee of Golestan Univercity of Medical Sciences Phalsaphy complex, Shast kola Road Gorgan Golestan Iran (Islamic Republic of)