the purpose of the study: explanation of bloating according to traditional Iranian medicine. assessment of effect of dietary modification in bloating. inclusion criteria: Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months. Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel syndrome, or other functional GI disorder. Criteria fulfilled for the last 6 months with symptom onset at least 6 months prior to diagnosis. exclusion criteria: abnormal abdominal examination. having acute or chronic gastrointestinal disease need surgery. gestation or lactation in women in gestational age. having disabling disease. existence of warning sign for example weight loss more than 4 kg in the last 3 month or blood in stool or melena or bloody vomiting in last 3 month. celiac diagnosis. lactase deficiency. lack of corporation or lack of itnerest in following the project. type of study: clinical trial. before after. sample size: 35 person. interventions of study: education of dietary modification. the duration of intervention: 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050633827N1
Registration date:2017-06-07, 1396/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
زهره مرتجی
Name of organization / entity
shahed university
Country
Iran (Islamic Republic of)
Phone
+98 5121
Email address
z.mortaji@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
shahed university
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of dietary modification in Bloating
Public title
effect of dietry modification in bloating
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Recurrent feeling of bloating or visible distension at least 3 days/month in
the last 3 months. Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel
syndrome, or other functional GI disorder. Criteria fulfilled for the last 6 months with symptom onset at least 6 months prior to diagnosis.
exclusion criteria: abnormal abdominal examination. having acute or chronic gastrointestinal disease need surgery. gestation or lactation in women in gestational age. having disabling disease. existence of warning sign for example weight loss more than 4 kg in the last 3 month or blood in stool or melena or bloody vomiting in last 3 month. celiac diagnosis. lactase deficiency. lack of corporation or lack of itnerest in following the project.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahed university
Street address
shahed university. khalij fars highway.
City
tehran
Postal code
9310
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR.Shahed.REC.1395.249
Health conditions studied
1
Description of health condition studied
bloating
ICD-10 code
K31
ICD-10 code description
Disease of oesophagus, stomach and duodenum
Primary outcomes
1
Description
bloating
Timepoint
start of study. 4 weeks after start of intervention
Method of measurement
questionnaire of gastrointestinal symptoms intensity
Secondary outcomes
1
Description
belching
Timepoint
start of study. 4 weeks after intervention
Method of measurement
questionnaire of gastrointestinal symptoms intensity
2
Description
acidify
Timepoint
start of study. 4 weeks after intervention
Method of measurement
questionnaire of gastrointestinal symptoms intensity
Intervention groups
1
Description
1 training session.
The duration of each session: 30 min.
Subjects: dietary modification based on Traditional Iranian Medicine. including:
- Prohibition of drinking water a half hour before meals, while eating, up to an hour after eating.
-chewing each bite 30 times.
-prohibition of eating salad or jelly with meals.
-Reducing the amount of food at each meal.
These should run for 4 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
mostafa khomeini hospital
Full name of responsible person
zohreh mortaji
Street address
italia street, keshavers blv
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahed university
Full name of responsible person
dr. zahra kiasalari
Street address
khalij fars highway
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahed university
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
shahed university
Full name of responsible person
zohreh mortaji
Position
resident of traditional medicine
Other areas of specialty/work
Street address
khalij fars highway
City
tehran
Postal code
9310
Phone
+98 21 5121
Fax
Email
z.mortaji@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahed university
Full name of responsible person
dr. elham emaratkar
Position
assistant professor
Other areas of specialty/work
Street address
khalij fars highway
City
tehran
Postal code
9310
Phone
+98 21 5121
Fax
Email
emaratkar@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shahed university
Full name of responsible person
zohreh mortaji
Position
resident of traditional medicine
Other areas of specialty/work
Street address
khalij fars highway
City
tehran
Postal code
9310
Phone
+98 21 5121
Fax
Email
zohreh.mortaji@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)