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IRCT20221012056153N1 IRCT 2023-03-16 Mashhad University of Medical Sciences The effect of pomegranate juice on allergic rhinitis The effect of sweet pomegranate juice on the severity of symptoms in patients with allergic rhinitis: A double-blinded, randomized clinical trial 2022-12-22 anticipated 60 Complete https://irct.ir/trial/66557 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Allergic rhinitis. Intervention 1: 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. Intervention 2: Control group: In the control group, patients will receive antihistamine and corticosteroid drugs for 8 weeks. Yes - There is a plan to make this available What will be shared: Part of the data, such as information related to the main outcome or similar, can be shared When: The access period begins 6 months after the publication of the results To whom: Researchers working in academic and scientific institutions or people who are also working in the industry can apply for them. Conditions: Drug discovery Where to obtain: Corresponding researcher How to obtain: one week Comments:
public Dr Mahdi Bakhshaee
Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3180 1265 bakhshaeem@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Maryam akaberi
Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3180 1265 akaberim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 60 years Both 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 J30.4 Allergic rhinitis, unspecified Treatment - Drugs Treatment - Drugs 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. Control group: In the control group, patients will receive antihistamine and corticosteroid drugs for 8 weeks 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). 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. Th1/Th2 cytokines. Timepoint: Beginning and end of the study (zero and 60 days). Method of measurement: Collection of blood samples from patients. 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. 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. Mashhad University of Medical Sciences Approved 2022-05-10 Ethics committee of Mashhad University of Medical Sciences Vakilabad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)