Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: the group receiving ellagic acid (200mg daily) Control group: placebo group
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Main outcome variables
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Inflammatory factors, oxidative stress indices and quality of life
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141025019669N11
Registration date:
2019-01-12, 1397/10/22
Registration timing:
registered_while_recruiting
Last update:
2019-10-01, 1398/07/09
Update count:
1
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Registration date
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2019-01-12, 1397/10/22
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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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Expected recruitment start date
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2018-12-01, 1397/09/10
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Expected recruitment end date
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2019-03-01, 1397/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Ellagic acid supplementation in patient with irritabe bowel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 19 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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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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2018-11-20, 1397/08/29
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Ethics committee reference number
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IR.QUMS.REC.1397.201
Health conditions studied
1
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Description of health condition studied
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Irritable bowel syndrome
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ICD-10 code
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K58.0
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ICD-10 code description
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Irritable bowel syndrome with diarrhea
Primary outcomes
1
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Description
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Inflammatory factors
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Eliza
2
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Description
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Antioxidant indices
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Eliza
3
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Description
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Quality of life
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Irritable Bowel Syndrome Quality of Life Questionnaire.
4
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Description
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Sleep quality
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Petersburg’s sleep quality questionnaire
Intervention groups
1
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Description
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Intervention group: Ellagic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot
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Category
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Treatment - Drugs
2
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Description
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Control group: A daily placebo capsule containing wheat flour for two months
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Category
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Treatment - Drugs
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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Qazvin 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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No - There is not 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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By contacting the email address of a person responsible for general inquiries
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When the data will become available and for how long
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After completing the study and analyzing the data
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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There is no objection to the use of data provided the source of the resource.
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From where data/document is obtainable
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By contacting the email address of a person responsible for general inquiries
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What processes are involved for a request to access data/document
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Six months after the study
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Comments
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