The effects of oral supplementation ellagic acid on anti-oxidant status, inflammatory markers, and quality of life in a patient with irritabe bowel syndrome: randomized double-blind clinical trial
The determination of inflammatory factors including Interleukin 6 (IL-6), C-reactive protein (CRP), total antioxidant capacity(TAC), malondialdehyde concentration and quality of life score
Design
In this study, 44 patients with irritable bowel syndrome who are eligible for inclusion in the study and referred to the Gastroenterology Department of Velayat Hospital of Qazvin University of Medical Sciences are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.
Settings and conduct
This study is a randomized double-blind clinical trial. People with irritable bowel syndrome referring to the Department of the Gastroenterology Department of Velayat Hospital of Qazvin University of Medical Sciences, are referred by a gastroenterologist, consultant to this study. Then, 44 patients were selected and randomly divided into intervention and control groups. In this study, the investigator and the patient will be blinded to drugs and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients who are 19-60 years old diagnosed with Irritable Bowel Syndrome according to ROME III criteria; Signed consent by the patient. Exclusion criteria: The patients who have celiac disease; any other diseases of the gastrointestinal tract; abdominal surgery; chronic disease such as diabetes, cardiovascular, hepatic, kidney and severe infection; pregnancy; breastfeeding; alcohol consumption; Use of dietary supplements.
Intervention groups
Intervention group: the group receiving ellagic acid (200mg daily) Control group: placebo group
Main outcome variables
Inflammatory factors, oxidative stress indices and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141025019669N11
Registration date:2019-01-12, 1397/10/22
Registration timing:registered_while_recruiting
Last update:2019-01-12, 1397/10/22
Update count:1
Registration date
2019-01-12, 1397/10/22
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oral supplementation ellagic acid on anti-oxidant status, inflammatory markers, and quality of life in a patient with irritabe bowel syndrome: randomized double-blind clinical trial
Public title
Ellagic acid supplementation in patient with irritabe bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with irritable bowel syndrome
Exclusion criteria:
Patients with gastrointestinal problems such as celiac disease and infection of the gastrointestinal tract
Age
From 19 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done with simple random method using the lottery. For each patient, a number or code is provided, then the numbers will be written on pieces of paper. The pieces of paper are placed in a container and well stirred, and the sample is selected according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients of both sexes are randomly divided into two groups, intervention and control groups, using a randomized distribution method. In this study, the patient and researcher are blinded to medicine and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.QUMS.REC.1397.201
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea
Primary outcomes
1
Description
Inflammatory factors
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
2
Description
Antioxidant indices
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
3
Description
Quality of life
Timepoint
Before intervention and after intervention
Method of measurement
Irritable Bowel Syndrome Quality of Life Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ellagic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot
Category
Treatment - Drugs
2
Description
Control group: A daily placebo capsule containing wheat flour for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Peimani
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@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
No - There is not 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
By contacting the email address of a person responsible for general inquiries
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
By contacting the email address of a person responsible for general inquiries
What processes are involved for a request to access data/document