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General information
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40
40
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2019-01-15, 1397/10/25
2019-01-15 00:00:00
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2019-06-05, 1398/03/15
2019-06-05 00:00:00
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2019-08-06, 1398/05/15
2019-08-06 00:00:00
Protocol summary
Study aim
Determining the efficacy of lifestyle interventions based on thetraditional Iranian medicine in improving functional bloating
Design
Clinical trial with control group, with parallel groups, without blindness, simple randomized, with a sample size of 40 patients.
Settings and conduct
The research sample includes 40 patient with functional bloating. They will be randomly divided into intervention and control groups. Teachings of the life style based on Iranian medicine will be conducted during the sessions for the intervention group in the health center of traditional medicine of Fasa University of Medical Sciences. The Control group will not be received any intervention during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with functional bloating symptoms consistent with ROME III criteria
Exclusion criteria:
gastrointestinal disorders such as irritable bowel syndrome;
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.
Intervention groups
The intervention includes modifying the lifestyle of patients with functional bloating and includes eating, drinking, physical activity, sexual activity and sleep patterns based on traditional Iranian medicine.
Patients in the control group should not change their lifestyle.
Main outcome variables
The score of the functional bloating complications questionaire, the intensity of rectal gas (flatulence), the amount of abdominal distension, the amount of burping (eructation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040211N1
Registration date:2019-05-28, 1398/03/07
Registration timing:registered_while_recruiting
Last update:2019-06-15, 1398/03/25
Update count:1
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Ahmadreza Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 4402
Email address
sharifi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-15, 1397/10/25
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
2019-01-15, 1397/10/25
Actual recruitment end date
2019-06-05, 1398/03/15
Trial completion date
2019-08-06, 1398/05/15
Scientific title
The effectiveness of lifestyle intervention based on Iranian traditional medicine prespective in patient with functional bloating
Public title
The effectiveness of Iranian traditional medicine in functional bloating
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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;
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Shahid Nasrati Alley, South Sheikh Bahayi St, Mulla Sadra St, Vank Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.BMSU.REC.1395.329
Health conditions studied
1
Description of health condition studied
Functional Bloating
ICD-10 code
R14
ICD-10 code description
Flatulence and related conditions
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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
9
Description
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
10
Description
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
11
Description
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
12
Description
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
13
Description
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
14
Description
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
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
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.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Traditional Medicine of Fasa University of Medical Sciences
Full name of responsible person
Alireza Moulazade
Street address
No. 8, Fayazbakhsh St, Poste darabi square, Fasa town