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IRCT20240116060709N1 IRCT 2024-02-21 Gonabad University of Medical Sciences Investigating the effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux The effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux disease 2024-02-24 anticipated 70 Complete https://irct.ir/trial/75409 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the pre-test, patients are randomly assigned to one of the intervention or control groups based on the random numbers table. For this purpose, a list of patients with entry criteria is prepared and no intervention is performed in the control group and gastrolith capsules are consumed twice a day in the intervention group. 3 Gastroesophageal reflux disease. Intervention 1: Intervention group: After completing the demographic questionnaire and gastric reflux disease questionnaire, one gastrolith capsule (containing 20 mg of Shirazi thyme essential oil, manufactured by Iran's Barij Essential Pharmaceutical Company) is given to the patients after noon and night meals for 6 weeks. After every 7 days, the use of Gastrolite capsules is stopped for 2 days, and after 2 days of non-use, the use of Gastrolite capsules is resumed. Drug consumption is controlled by telephone every week, after the end of the study, the patients will complete the reflux disease questionnaire again, and the patients who have not used Shirazi thyme essence capsules for 5 days will be excluded from the study. Intervention 2: Control group: After completing the demographic questionnaire and the gastric reflux disease questionnaire, no intervention is performed for the patients and for these patients the educational and treatment procedures are carried out normally. Yes - There is a plan to make this available What will be shared: All potential data can be shared once individuals are identified. When: The access period starts 6 months after the publication of the results To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions can apply for clinical use after coordination with the main researcher of this research. Where to obtain: Name: Benyamin Borhani Phone number: 00989155355135 email: Benyaminborhani72@gmail.com Postal code: 9674110033 How to obtain: After the request is announced by the requester, the request is reviewed and information is sent to the requester within one month. Comments:
public Benyamin Borhani
Gonabad University of Medical Sciences, Ghadir Square
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3513 benyaminborhani72@gmail.com Gonabad University of Medical Sciences scientific Habib Shareinia
Gonabad University of Medical Sciences, Ghadir Square
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3513 Habibshareinia@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Willingness to attend the study Patients with second grade reflux severity (patients who were not able to resolve their symptoms with lifestyle changes alone) Age 20 to 60 years Absence of pregnancy and breastfeeding Absence of allergy to thyme Not having diabetes No previous upper gastrointestinal surgery Absence of positive and clinically significant gastrointestinal bleeding in the last three months Absence of proven diseases such as: bleeding disorder, Barrett's Esophagus,esophageal varices, duodenal/stomach ulcer and upper gastrointestinal tract malignancy Able to read, understand and complete the questionnaire 20 years 60 years Both Reluctance to continue research Hospitalization during the study Not using gastrolith capsules for more than 5 days K21.9 Gastro-esophageal reflux disease without esophagitis Treatment - Drugs Lifestyle Intervention group: After completing the demographic questionnaire and gastric reflux disease questionnaire, one gastrolith capsule (containing 20 mg of Shirazi thyme essential oil, manufactured by Iran's Barij Essential Pharmaceutical Company) is given to the patients after noon and night meals for 6 weeks. After every 7 days, the use of Gastrolite capsules is stopped for 2 days, and after 2 days of non-use, the use of Gastrolite capsules is resumed. Drug consumption is controlled by telephone every week, after the end of the study, the patients will complete the reflux disease questionnaire again, and the patients who have not used Shirazi thyme essence capsules for 5 days will be excluded from the study. Control group: After completing the demographic questionnaire and the gastric reflux disease questionnaire, no intervention is performed for the patients and for these patients the educational and treatment procedures are carried out normally. Percentage of people with second-degree gastroesophageal reflux (patients who were not able to resolve their symptoms only by lifestyle changes). Timepoint: Before the intervention and 45 days after the intervention. Method of measurement: Reflux disease questionnaire. Gonabad University of Medical Sciences Approved 2023-07-19 Ethics Committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Ghadir Square Gonabad Razavi Khorasan Iran (Islamic Republic of)