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IRCT20230316057734N1 IRCT 2023-06-24 Mazandaran University of Medical Sciences The effect of Ardor syrup on the severity of functional bloating in the elderly Investigating the effect of Ardor syrup on the severity of functional bloating in the elderly 2023-07-23 anticipated 72 Complete https://irct.ir/trial/69276 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the samples will be determined and the blocking method will be used to allocate the samples. This process will be done with Random allocation software. With this software, 12 block of 6 will be created and the samples will be assigned to each of the blocks and groups accordingly. It should be noted that three samples from the drug group and three samples from the placebo group will be placed in each block with A or B signs, Blinding description: The medicines and placebos will be prepared in the same color and packaging bottle, and before the intervention will be coded by a statistical expert cooperator, so that the researcher and the patient will not know the type of intervention. 3 Bloating. Intervention 1: Intervention group: Arder syrup, 5 cc every 12 hours until one hour after meals. (Arder syrup consists of Pimpinella anisum seed, Foeniculum vulgare seed, Apium graveolens seed, Rosa damascene petal and Crocus sativus stigma. Intervention 2: Control group: Placebo syrup, will be prepared in the same color and container as drug syrup, 5 cc every 12 hours until one hour after meals. 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 Asieh Jokar
Traditional and Complementary Medicine Research Center of Mazandaran University, Khazar Blvd, Khazar Square
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Asieh Jokar
Traditional and Complementary Medicine Research Center of Mazandaran University, Khazar Blvd, Khazar Square
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 3117 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) People older than 60 years, whose Functional bloating has been confirmed by a Gastroenterologist based on Rome III criteria Consent of the individual for voluntary participation in research 60 years no limit Both History of taking Anti H. pylori medicine in the last tree months. Patients with a History of stomach or intestinal surgery Patients with diabetes or severe mental illness Patients who take antibiotics History of allergy to Herbal medicines R14 Flatulence and related conditions Treatment - Drugs Placebo Intervention group: Arder syrup, 5 cc every 12 hours until one hour after meals. (Arder syrup consists of Pimpinella anisum seed, Foeniculum vulgare seed, Apium graveolens seed, Rosa damascene petal and Crocus sativus stigma. Control group: Placebo syrup, will be prepared in the same color and container as drug syrup, 5 cc every 12 hours until one hour after meals. Intensity of bloating. Timepoint: Measuring the intensity of bloating before the study (day zero), 7, 14, 21, 28. Method of measurement: 7-point Likert scale (Gastrointestinal symptom severity questionnaire). Number of bowel movements. Timepoint: The day before starting the study (day zero), 7, 14, 21, 28. Method of measurement: Questionnaire. Mazandaran University of Medical Sciences Approved 2023-06-10 Ethics committee of Mazandaran University of Medical Sciences Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square Sari Mazandaran Iran (Islamic Republic of)