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Study aim
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The goal of this study is to provide herbal medicines with the least complications in controlling the symptoms of gastroesophageal reflux disease in adults 18 years of age and older in order to reduce the amount of drug use and minimize the side effects of the drugs. In this double-blind, randomized clinical trial, the effects of Mastic and Coriander Triphala on gastroesophageal reflux disease will be investigated.
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Design
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Participants in this study will be randomly divided in three parallel groups (two intervention groups and one control group) considering inclusion and exclusion criteria. In each block 52 participants will be studied through a double blind study.
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Settings and conduct
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18 year-old and above men and women with gastroesophageal reflux criteria who are referred to outpatient clinics of Shahid Madani, Sina and Imam Reza hospitals and endoscopic department of Shahid Madani and Imam Reza Hospitals in Tabriz city will be selected by unintended sampling method; and after obtaining written consent for participation in this research, they will be randomly divided to three groups (one control group and two intervention groups). The study is double blind. Drug and placebo instructions will be provided in the package. In all of the groups, a capsule in a small plastic will be taken before breakfast and the rest of the capsules will be consumed after a meal for 4 weeks. According to other studies, the sample size is 156 (52 participants in each intervention group and 52 participants in the control group).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Men and women 18 years old and older; Heartburn at least once a week; Return food from the stomach to the esophagus and mouth; Basic literacy (at least reading and writing skills);
Exclusion criteria:
Taking anti-reflux medications; There are warning signs of weight loss, anemia, severe vomiting and food sting that have not been evaluated by endoscope; Barrett's esophagus; Esophagitis with non-reflux causes; Taking NSAID Drugs
Pregnancy; Systemic diseases (liver disease, kidney disease, uncontrolled diabetes);
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Intervention groups
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Intervention group 1: In this group, patients will receive two Mastic capsules (each containing 500 mg of Mastic) three times a day for 4 weeks (Prepared from Tooba pharmacy -Ostad Nazem).
Intervention group 2: In this group, patients will receive two Coriander Triphala capsules (each containing 500 mg of Coriander Triphala) three times a day for 4 weeks (Prepared from Tooba pharmacy -Ostad Nazem).
Control group: In this group, patients will receive one Omeprazole capsule -20 mg- (packed in 500 mg capsule sachets) and 5 placebo capsules in a day.
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Main outcome variables
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The number of days the patient has heartburn (A burning feeling behind breastbone); The number of days the patient has regurgitation (stomach contents (liquid or food) moving upwards to throat or mouth); The number of days the patient has pain in the stomach (heartburn); The number of days the patient has nausea; The number of days the patient hasn't slept well due to heartburn or regurgitation; The number of days the patient uses other drugs in addition to previously prescribed medications due to heartburn or reflux; Quality of life; Duration of drug intake; Drug side effects.