Determining the effect of pomegranate juice on the severity of symptoms in patients with allergic rhinitis
Design
A randomized superiority double blinded clinical trial. n=60, randomization will be conducted with blocking method through www.randomization.com
Settings and conduct
This clinical trial will be conducted in the Allergy, Ear, Nose, and Throat Clinic of Imam Reza and Qaim Hospital as a randomized, double-blind clinical trial. Patients with allergic rhinitis who visit the hospital clinic as an outpatient will be evaluated individually by a doctor. The patients who meet the conditions to enter the study are included and assigned to intervention and control groups using a simple randomization method. After obtaining the patient's consent (complete explanation of the plan), their approval is obtained. The severity of the disease in these patients will be evaluated at the beginning of the project by interviewing the doctor and using the standard Sino-Nasal Test 20 questionnaire. The result will be recorded in the questionnaire for each patient.
Participants/Inclusion and exclusion criteria
Allergic rhinitis patients
People aged 18 to 60 years
Exclusion criteria:
Pregnancy or breastfeeding
non-allergic rhinitis
systemic diseases
Taking herbal supplements with antioxidant properties
Liver dysfunction
Kidney dysfunction
Thyroid disorders
Epilepsy
Intervention groups
In the intervention group, patients will receive sweet pomegranate juice concentrate (ml/day 50) and antihistamine and corticosteroid drugs and
in the control group, patients will receive antihistamine and corticosteroid drugs for 2 months.
Main outcome variables
Determining the severity of clinical symptoms of patients using the SNOT-20 questionnaire, Salsola-specific IgE , Th1/Th2 cytokines, interferon (IFN)-γ, and interleukin IL-4 and IL-5 concentrations before the intervention and at the end of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221012056153N1
Registration date:2023-03-16, 1401/12/25
Registration timing:retrospective
Last update:2023-03-16, 1401/12/25
Update count:0
Registration date
2023-03-16, 1401/12/25
Registrant information
Name
Maryam Akaberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1265
Email address
akaberim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sweet pomegranate juice on the severity of symptoms in patients with allergic rhinitis: A double-blinded, randomized clinical trial
Public title
The effect of pomegranate juice on allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Allergic rhinitis patients
Patients who have been treated with standard drugs including antihistamines and corticosteroids for at least 4 weeks and have had a poor or no response to these treatments are included in the study.
Exclusion criteria:
Pregnancy or breastfeeding
Patients with non-allergic rhinitis
Patients with systemic diseases
Use of herbal supplements with antioxidant properties
Liver dysfunction (LFT>3ULN)
Kidney dysfunction (GFR<60 ml/kg/min)
Thyroid disorders (based on thyroid function test)
Epilepsy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The size of each block will be 4. Then write the list of blocks and assign numbers to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 8 blocks according to the sample size of 30 people. Then the selection of random numbers according to the site WWW.randomization.com and finally the prepared blocks will be placed in the envelope. According to the order of arrival of patients, one of the envelopes will be randomly selected and patients will be assigned to groups based on the obtained blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the non-use of placebo in the control group, only the therapists will not be informed about the assigned treatment, and the analyst will also be unaware of the assigned treatment to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals the code A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.121
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Determining the severity of clinical symptoms of patients (including sneezing, an itchy nose, a runny or blocked nose, itchy, red and watery eyes, a cough, the roof of mouth being itchy)
Timepoint
Beginning and end of the study (zero and 60 days)
Method of measurement
Using of Sino-Nasal Test 20 (SNOT-20)
Secondary outcomes
1
Description
The level of specific IgE
Timepoint
Beginning and end of the study (zero and 60 days)
Method of measurement
Collection of blood samples from patients
2
Description
Th1/Th2 cytokines
Timepoint
Beginning and end of the study (zero and 60 days)
Method of measurement
Collection of blood samples from patients
3
Description
Determination of interferon (IFN)-γ concentration
Timepoint
Beginning and end of the study (zero and 60 days)
Method of measurement
Collection of blood samples from patients
4
Description
Determination of interleukin IL-4 and IL-5 concentrations
Timepoint
Beginning and end of the study (zero and 60 days)
Method of measurement
Collection of blood samples from patients
Intervention groups
1
Description
Intervention group: Patients will receive sweet pomegranate juice concentrate (ml/day 50) for 2 months, in addition to taking antihistamine and corticosteroid drugs. Pomegranate concentrate refers to concentrated pomegranate juice. The concentrate is purchased from one of the concentrate production companies (Narni, Tehran, Website: https://narni.ir/). Then the concentrate is divided into syrup jars and kept in the freezer until use.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients will receive antihistamine and corticosteroid drugs for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy, ear, throat and nose clinic of Imam Reza and Qaim Hospital
Full name of responsible person
Dr Mahdi Bakhshaee
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1265
Email
akaberim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahdi Bakhshaee
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1265
Email
akaberim@mums.ac.ir
Grant name
Mashhad University of Medical Sciences (4000758)
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahdi Bakhshaee
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3180 1265
Email
bakhshaeem@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Maryam akaberi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3180 1265
Email
akaberim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mina Shekari
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3180 1265
Email
ShekariM991@mums.ac.ir
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
Part of the data, such as information related to the main outcome or similar, can be shared
When the data will become available and for how long
The access period begins 6 months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions or people who are also working in the industry can apply for them.
Under which criteria data/document could be used
Drug discovery
From where data/document is obtainable
Corresponding researcher
What processes are involved for a request to access data/document