Determining the complementary effect of pomegranate peel extract on inflammatory factors and quality of life in patients with ulcerative colitis
Design
Samples are assigned to the voice available and are divided into two equal groups by software and blocking, which are matched in terms of age and gender.
Settings and conduct
Samples are collected and registered in Imam Reza Hospital in Tabriz and examined during two months of intervention. Blinding is done in the researcher and the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria include a willingness to participate in the study, ages 18 to 70, both male and female, the patient diagnosed by a gastroenterologist, and for two consecutive months the patient's condition is stable.
Exclusion criteria include pomegranate allergy, heart disease, diabetes, hepatitis, etc.
Intervention groups
Pomegranate supplement tablets are given to the intervention group as interventions and similar pills, but without pomegranate peel extract, are given to the control group.
Main outcome variables
The effect of pomegranate supplement on inflammatory factors; Effects on fecal calprotectin; Impact on the severity of symptoms; Impact on quality of life; And the effect on anthropometric indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200614047774N1
Registration date:2020-09-29, 1399/07/08
Registration timing:registered_while_recruiting
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Majid Keramati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4634 4017
Email address
majidkeramati87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pomegranate peel extract supplement on inflammatory factors and quality of life in Ulcerative Colit patients
Public title
The effect of Pomegranate supplement on Ulcerative Colit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Disease diagnosed by a Gastroenterologist
The patient's medical condition has been stable for the past two months
The desire to participate in the study
Exclusion criteria:
Sensitivity to pomegranate or its products
Pregnancy
Lactation
Taking steroid drugs, other experimental drugs, and probiotics
Kidney, heart and hepatitis
Taking other nutritional supplements
Having a special diet
Age
From 18 years old to 70 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
Among the patients, according to the criteria of entry and non-entry, 44 patients will be selected as the available sample. The selected individuals are then randomly assigned (using software and blocking) to two intervention groups and a placebo that will be matched in terms of age and gender.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the researcher and patients, pomegranate and placebo supplements are divided into groups A and B by a person other than the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Jomhoory
City
Jandagh
Province
Isfehan
Postal code
8363136654
Approval date
2020-09-14, 1399/06/24
Ethics committee reference number
IR.TBZMED.REC.1399.658
Health conditions studied
1
Description of health condition studied
Ulcerative Colit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
IL-6
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
2
Description
IL-10
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
3
Description
TNF-alpha
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
4
Description
hs-CRP
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
5
Description
ANCA
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
6
Description
Fecal Calprotectin
Timepoint
The beginning and end of the study
Method of measurement
laboratory test
Secondary outcomes
1
Description
Quality of life
Timepoint
The beginning and end of the study
Method of measurement
IBDQ-9 questionaire
2
Description
Severity of symptoms
Timepoint
The beginning and end of the study
Method of measurement
SCCAI questionair
3
Description
Antropometric Index
Timepoint
The beginning and end of the study
Method of measurement
Body measurement
Intervention groups
1
Description
Intervention group: 22 patients with ulcerative colitis who will receive two supplements of pomegranate supplements containing 225 mg of dried pomegranate extract for 8 weeks daily after breakfast and lunch. This supplement is from Amin Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: 22 patients with ulcerative colitis who will receive two pills similar to pomegranate supplement pills daily for 8 weeks but without dried pomegranate peel extract after breakfast and lunch. The platform will be built by Amin Pharmaceutical Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Masuod Faghih Dinevari
Street address
Attar
City
Tabriz
Province
East Azarbaijan
Postal code
8363136654
Phone
+98 31 4634 4017
Fax
Email
majidkeramati87@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Attar
City
Tabriz
Province
East Azarbaijan
Postal code
8363136654
Phone
+98 31 4634 4017
Email
majidkeramati87@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz Univercity 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Keramati
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Jomhoori
City
Jandagh
Province
East Azarbaijan
Postal code
8363136654
Phone
+98 31 4634 4017
Fax
Email
majidkeramati87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Keramati
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Jomhoori
City
Jandagh
Province
East Azarbaijan
Postal code
8363136654
Phone
+98 31 4634 4017
Fax
Email
majidkeramati87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Keramati
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Jomhoori
City
Jandagh
Province
East Azarbaijan
Postal code
8363136654
Phone
+98 31 4634 4017
Fax
Email
majidkeramati87@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD