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IRCT20180623040211N1 IRCT 2019-05-28 Bagheiat-allah University of Medical Sciences The effectiveness of Iranian traditional medicine in functional bloating The effectiveness of lifestyle intervention based on Iranian traditional medicine prespective in patient with functional bloating 2019-01-15 anticipated 40 Complete https://irct.ir/trial/39351 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly divided into intervention and control groups using a lottery method. As the names of all participants are placed inside the container. The names are drawn out from the container, respectively, and placed in the intervention and control groups. At the end, the papers containing the names are opened and different groups are determined. N/A Functional Bloating. Intervention 1: Intervention group: Functional bloating patients are taught the teachings of the style of life based on Iranian medicine. These fifteen trainings have already been prepared and standardized by a group of traditional medicine specialists and include eating, drinking, sleeping, physical and sexual activity, such as avoiding overeating, avoiding eating several types of foods together, and so on. Standardized recommendations can be provided if required. Intervention 2: Control group: A number of patients with functional bloating are placed in the control group. These patients are requested to make no changes to their lifestyle, eating and drinking habits during the two months of the clinical trial. 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 There is no further information
public Ahmad Reza Sharifi Alun-abadi
Baqiyatallah University of Medical Sciences, Shahid Nasrati Alley, South Sheikh Bahayi St, Mulla Sadra St, Vank Square, Tehran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 2415 a-sharifi@shahed.ac.ir Bagheiat-allah University of Medical Sciences scientific Ahmadreza Sharifi Alun-abadi
Baqiyatallah University of Medical Sciences, Shahid Nasrati Alley, South Sheikh Bahayi St, Mulla Sadra St, Vank Square, Tehran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 2415 a-sharifi@shahed.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with functional bloating symptoms consistent with ROME III criteria include: 1.Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months; 2.Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel syndrome, or other functional GI disorder. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis 18 years 60 years Both Existing gastrointestinal ulcer diagnosis by internal medicine specialist; Acute abdominal pain; Gastrointestinal organ diseases such as inflammatory bowel disease, peptic ulcer or duodenal ulcer and functional constipation are recognized by an internal medicine specialist; Severe mental illness; Severe uncontrolled systemic diseases such as cardiac, pulmonary, and hepatic impairment; Taking aspirin or nonsteroidal anti-inflammatory drugs, corticosteroids, antibiotics, proton pump inhibitor drugs; Pregnancy or breastfeeding; Severe weight loss, black stool or bitumen color; R14 Flatulence and related conditions Lifestyle Lifestyle Intervention group: Functional bloating patients are taught the teachings of the style of life based on Iranian medicine. These fifteen trainings have already been prepared and standardized by a group of traditional medicine specialists and include eating, drinking, sleeping, physical and sexual activity, such as avoiding overeating, avoiding eating several types of foods together, and so on. Standardized recommendations can be provided if required. Control group: A number of patients with functional bloating are placed in the control group. These patients are requested to make no changes to their lifestyle, eating and drinking habits during the two months of the clinical trial. The score of the functional bloating complications questionaire. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Functional bloating complications questionnaire. The amount of epigastric distension after the usual meal. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The amount of distension and bulging in the lower abdomen. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of rectal gas (flatulence). Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The amount of burping (eructation). Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of abdominal rumbling. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of early satiety in eating (The inability to finish the usual meal). Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The severity of postprandial fullness after a typical meal. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of bloating after bloatable food eating. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of bloating in hunger and without food. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of bloating during menstruation. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of nausea after eating. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of nausea in hunger and without food. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of retching. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. The intensity of epigastric pain. Timepoint: To evaluate the severity of the complication at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Visual analogue scale. Bagheiat-allah University of Medical Sciences Approved 2017-03-13 The Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Shahid Nasrati Alley, South Sheikh Bahayi St, Mulla Sadra St, Vank Square, Tehran. Tehran Tehran Iran (Islamic Republic of)