Protocol summary
-
Study aim
-
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 20 ml / liter per day (about two tablespoons) for 4 weeks.
-
Main outcome variables
-
Elimination chronic constipation
General information
-
Reason for update
-
In the implementation method, the amount of olive oil given to people with constipation is two tablespoons, which is equivalent to 20 ml, but at the time of registration, 4 ml was incorrectly mentioned.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20080901001155N33
Registration date:
2021-03-01, 1399/12/11
Registration timing:
registered_while_recruiting
Last update:
2021-05-07, 1400/02/17
Update count:
1
-
Registration date
-
2021-03-01, 1399/12/11
-
Registrant information
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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 20 ml 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 20 ml per day (about two tablespoons) for 4 weeks.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
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
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
-
Comments
-