Protocol summary
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Study aim
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The effect of Specific Dietary Interventions in Postprandial Distress Syndrome.
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Design
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This study is a randomized without placebo-controlled.
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Settings and conduct
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This study include Two groups. Each group consist of Postprandial Distress Syndrome patients, One group with adlibitum diet (27 patients) and intervention group (29 patients) with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes performed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding.
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Intervention groups
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Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital.
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Main outcome variables
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severity of Functional Dyspepsia.
General information
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Reason for update
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Updates are performed to fill in the blanks
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015050322049N1
Registration date:
2015-08-06, 1394/05/15
Registration timing:
prospective
Last update:
2020-07-28, 1399/05/07
Update count:
1
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Registration date
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2015-08-06, 1394/05/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shahed University of Medical Sciences
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Expected recruitment start date
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2015-06-22, 1394/04/01
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Expected recruitment end date
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2015-11-22, 1394/09/01
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Actual recruitment start date
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2017-04-08, 1396/01/19
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Actual recruitment end date
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2018-10-29, 1397/08/07
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Trial completion date
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2018-10-29, 1397/08/07
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Scientific title
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Assessment of effect of Specific Dietary Interventions on severity of Dyspepsia in patients with Postprandial Distress Syndrom
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Public title
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The effect of Specific Dietary Interventions in Postprandial Distress Syndrom
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients with 18-75 years old;
Willing to cooperate;
Early Satiety or bothersome postprandial fullness more than 3 months;
Without Organic Disorders on physical examination;
normal Endoscopic.
Exclusion criteria:
Patients with organic disorders; T
he use of Chemicals and Herbals any other medication;
History of Abdominal surgeries;
History of bloody diarrhea;
Pregnancy and breast feeding;
Lack of interest in work;
Not sign the consent.
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: blocking
Randomization unit: individual
In this method, each person was considered as a block.
Because there were two groups of intervention (a) and control (b), it was determined based on quadruple blocks and by drawing blocks, and thus each person was placed in the intervention and control group. for example:
A B A B
B A A B
B B A A ,......
Random allocation software was used for randomization.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-04-27, 1394/02/07
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Ethics committee reference number
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Shahed.REC.1393.45
Health conditions studied
1
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Description of health condition studied
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Functional dyspepsia
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ICD-10 code
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k30
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ICD-10 code description
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Indigestion
Primary outcomes
1
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Description
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Severity Assessment of Dyspepsia
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
Secondary outcomes
1
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Description
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Postprandial fullness
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
2
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Description
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Early Satiety
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
3
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Description
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Bloating
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
4
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Description
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Nausea
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
5
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Description
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Belching
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Timepoint
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At baseline, 2 and 8 weeks after starting the intervention
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Method of measurement
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The Gastrointestinal Symptom Scale
Intervention groups
1
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Description
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Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks. In this diet, based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks.
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Category
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Lifestyle
2
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Description
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Control group: continue previous diet without restriction
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahed University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some data, such as information about the main outcome or the like, can be shared.
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When the data will become available and for how long
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The description includes both the time period and the start date of the access
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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In the form of publication of an article
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From where data/document is obtainable
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To the site of reputable domestic and foreign magazines
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What processes are involved for a request to access data/document
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It depends on the acceptance and publication of the article in the intended journal
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Comments
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