Comparison of the effectiveness of profenol olive oil and regular on chronic constipation
Design
All eligible individuals will be divided into intervention and control groups using block randomization method with 4 and 6 block sizes. To generate a randomization list from the online randomization service Sealed Envelope Ltd. 2019 was used (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Settings and conduct
The present study is a clinical trial study. In this study, 150 people with a diagnosis of constipation according to the Rome III criterion who referred to the Caspian Clinic will be randomly admitted to the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a criterion for diagnosing constipation based on the Rome III criterion, people over 18 years
Conditions of absence: Organic constipation, hypothyroidism, false intestinal obstruction, cystic fibrosis, neurological abnormalities, intestinal obstruction, opium use, use of laxatives
Intervention groups
One group will be given olive oil rich in polyphenols and the other group will be given regular olive oil. The amount of olive oil given will be 4 ml / liter per day (about two tablespoons) for 4 weeks.
Main outcome variables
Elimination chronic constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001155N33
Registration date:2021-03-01, 1399/12/11
Registration timing:registered_while_recruiting
Last update:2021-03-01, 1399/12/11
Update count:1
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-17, 1399/11/29
Expected recruitment end date
2021-08-19, 1400/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of olive oil rich in polyphenols and ordinary olive oil in the treatment of patients with chronic constipation
Public title
the effectiveness of olive oil rich in polyphenols and ordinary olive oil in the treatment of patients with chronic constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a constipation diagnosis based on the Rome III criterion
People over 18 years old
Exclusion criteria:
Existence of organic constipation
Hypothyroidism
False intestinal obstruction
Cystic fibrosis
Neurological anomalies
Ileus
Opium consumption
Taking laxatives such as MOM
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible individuals will be divided into intervention and control groups using block randomization method with 4 and 6 block sizes. To generate a randomization list from the online randomization service Sealed Envelope Ltd. 2019 was used (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and health care personnel will not be informed of the type of group therapy received in a double-blind manner. To do this, ordinary olive oil is quite similar to polyphenol olive oil will be ordered and provided to these people.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Research and Technology Deputy ,Shaheed Beheshti street,Gaz square,Rasht
City
Rasht
Province
Guilan
Postal code
41448956655
Approval date
2021-02-17, 1399/11/29
Ethics committee reference number
IR.GUMS.REC.1399.600
Health conditions studied
1
Description of health condition studied
Chronic constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Elimination chronic constipation
Timepoint
The questionnaire will be asked at the beginning of the patient's arrival and at the end of the fourth week
Method of measurement
The Rome III questionnaire
Secondary outcomes
1
Description
Stool deformity
Timepoint
At the end of each week, the patient will be asked by telephone
Method of measurement
Based on the Bristol Questionnaire
Intervention groups
1
Description
Intervention group: Olive oil rich in polyphenols,The amount of olive oil given will be 4 ml /l per day (about two tablespoons) for 4 weeks.
Category
Treatment - Other
2
Description
Control group: Ordinary olive oil,The amount of olive oil given will be 4 ml /l per day (about two tablespoons) for 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Caspian Digestive Disease Research Center
Full name of responsible person
Dr.Fariborz Mansour ghanaei
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3353 5116
Email
ghanaie@yahoo.com
2
Recruitment center
Name of recruitment center
Gastrointestinal and liver Disease Research Center
Full name of responsible person
Dr.Fariborz Mansour ghanaei
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3353 5116
Fax
+98 13 3353 4951
Email
ghanaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hadi Bahadori
Street address
Vice Chancellor for Research, Shahid Sadati St, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
41448-955655
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
bahadori@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & Gastroenterology
Latest degree
Subspecialist
Other areas of specialty/work
Specialist in gastrointestinal and liver diseases
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3353 5116
Email
ghanaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Farahnaz Joukar
Position
Deputy of Gastrointestinal and Liver Diseases Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3353 5116
Email
farajov@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mehrnaz Asgharnezhad
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-955655
Phone
+98 13 3353 5116
Email
asgharnezhad98@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcome of this study, which is chronic constipation, will be made available to the general public
When the data will become available and for how long
One year after printing results
To whom data/document is available
Researchers at relevant research centers, universities and related doctors
Under which criteria data/document could be used
In this case, the decision has not yet been taken
From where data/document is obtainable
Mehrnaz Asgharnezhad Gastrointestinal and Liver Diseases Research Center Guilan, Razi hospital, Rasht ,41448-955655,01333535116
What processes are involved for a request to access data/document
At the outset, the applicant will email and complete his or her full introduction of the organization and the purpose of obtaining this data and will request the relevant documents or files.Subsequently, the data files will be made available to the applicant within the time period stated by the relevant investigator