The Effect of Pomegranate peel extract on clinical symptoms ,stool calprotectin level and quality of life in patients with diarrhea-dominant irritable bowel syndrome : A double-blind randomized placebo-controlled clinical trial
The effect of pomegranate peel extract on clinical symptoms ,quality of life and stool calprotectin level of patients with diarrhea dominant irritable bowel syndrome
Design
This study was performed as a double-blind randomized clinical trial with a control group, with parallel groups, phase 3 on 62 patients. The two intervention groups and the control group were randomly by graphed software and the sample size using g-power software, There are 31 people in each group.
Settings and conduct
Sampling and diagnosis will be performed in gastrointestinal clinics affiliated to Tabriz University of Medical Sciences. In this study, for blinding, drug and placebo were prepared in similar packages and one of the colleagues will use labels A and B for differentiation. And none of the researchers as well as patients will be aware of the contents of A and B until the end of statistical analysis. patients, researchers, outcome evaluators, and data analysts will be blind.
Participants/Inclusion and exclusion criteria
1. Irritable bowel syndrome with predominant manifestation of diarrhea
2. Age over 18
3. Normal colonoscopy during the last 5 years
4. Stool calprotectin level above 50
Intervention groups
1. Intervention group: A group of patients with irritable bowel syndrome (IBS) with a predominant manifestation of diarrhea were randomly assigned to receive a drug package for two months.
2.Control group: A group of patients with IBS with a predominant manifestation of diarrhea were randomly assigned to receive a placebo package for two months.
Main outcome variables
1. Clinical symptoms before and after the intervention, which are scored by a questionnaire and will be a small criterion.
2. Fecal calprotectin levels before and after the intervention
3. Quality of life of patients before and after the intervention (scored by the Quality of Life Questionnaire for patients with irritable bowel syndrome)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051046N1
Registration date:2022-01-05, 1400/10/15
Registration timing:retrospective
Last update:2022-01-05, 1400/10/15
Update count:0
Registration date
2022-01-05, 1400/10/15
Registrant information
Name
Fateme Javanali Azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3320 1463
Email address
fateme.javan88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Pomegranate peel extract on clinical symptoms ,stool calprotectin level and quality of life in patients with diarrhea-dominant irritable bowel syndrome : A double-blind randomized placebo-controlled clinical trial
Public title
The effect of pomegranate peels extract on clinical symptoms of patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Irritable bowel syndrome patients with diarrhea dominant symptom
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using Graph pad software, so that the groups will be marked with two letters A and B. And then the software will assign each person to one of the groups A and B. This list will be prepared by one of the researchers who has no role in the other parts of the study and will be hidden from the others until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, medicine and placebo are prepared in similar packages and one of the colleagues will use labels A and B for differentiation and none of the researchers as well as patients will be aware of the contents of A and B until the end of statistical analysis.
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 science
Street address
Deputy of Research and Technology, 3th floor, Central building NO. 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-10-05, 1399/07/14
Ethics committee reference number
IR.TBZMED.REC.1399.686
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Score of clinical symptoms in first questionnaire
Timepoint
Before the intervention and 2 months after the beginning of intervention
Method of measurement
The second questionnaire
2
Description
Stool calprotectin level
Timepoint
Before the intervention and 2 months after the beginning of intervention
Method of measurement
Measured by the laboratory
3
Description
Quality of life
Timepoint
Before the intervention and 2 months after the beginning of intervention
Method of measurement
Quality of Life Questionnaire for Patients with Irritable Bowel Syndrome
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg capsules containing pomegranate peel extract daily for two months. These capsules are extracted from pomegranate peel by ethanolic extraction method. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention.
Category
Treatment - Drugs
2
Description
Control group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg placebo capsules daily for two months. These capsules are exactly the same shape and size as the capsules of the intervention group. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention.