Purpose: The effect of Specific Dietary Interventions in Postprandial Distress Syndrome. Design: This study is a randomized without placebo-controlled. People in study: Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital. 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. Target sample size: 60. Intervention: This study will include Two groups. Each group will consist of 30 Postprandial Distress Syndrome patients, One group with adlibitum diet and intervention group 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 will be performed. Primary outcome: severity of Functional Dyspepsia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050322049N1
Registration date:2015-08-06, 1394/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Fereshteh Nouri
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3333
Email address
fdr.nouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahed University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of Specific Dietary Interventions on severity of Dyspepsia in patients with Postprandial Distress Syndrom
Public title
The effect of Specific Dietary Interventions in Postprandial Distress Syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with 18-75 years old; Early Satiety or bothersome postprandial fullness more than 3 months; Without Organic Disorders on physical examination; normal Endoscopic. Exclusion criteria: Patients with organic disorders; The 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.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahed University of Medical Sciences
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
Shahed.REC.1393.45
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
k30
ICD-10 code description
Indigestion
Primary outcomes
1
Description
Severity Assessment of Dyspepsia
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
Secondary outcomes
1
Description
Postprandial fullness
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
2
Description
Early Satiety
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
3
Description
Bloating
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
4
Description
Nausea
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
5
Description
Belching
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
Intervention groups
1
Description
Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks
Category
Lifestyle
2
Description
Control group: continue previous diet without restriction
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Fereshteh Nouri
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Mohsen Naseri
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
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 of Medical Sciences
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 of Medical Sciences
Full name of responsible person
Fereshteh Nouri
Position
Traditional Iranian Medicine PHD student
Other areas of specialty/work
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
fdr.nouri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Abdi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Ayatollah Taleghani Hospital
City
Tehran
Postal code
Phone
+98 21 2243 2561
Fax
Email
saeedabdi75@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Fereshteh Nouri
Position
Traditional Iranian Medicine PHD student
Other areas of specialty/work
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
fdr.nouri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)