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IRCT20210309050643N1 IRCT 2021-06-28 Mashhad University of Medical Sciences Evaluation of the effect of Barley extract in the treatment of chronic urticaria Evaluation of the effect of Medicinal Ma-alshaeir( herbal product based on Iranian traditional medicine) in comparison with placebo on clinical symptoms of patients with Chronic Idiopathic Urticaria: A randomized triple-blind clinical trial 2021-06-22 anticipated 46 Complete https://irct.ir/trial/55325 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study will be block-randomization. each block has four numbers. The sequence produced by the https://www.sealedenvelope.com/ will be provided to the researchers by the project methodologist and will be placed in sealed, opaque, and numbered envelopes. The project researcher opens one of the envelopes when each patient enters the clinic and the patient will be assigned to the group mentioned in the envelope, Blinding description: Placebo and druge _same packaged_ marked by specified code and consumption instruction. patient and attentive and analyzer are blind ,at the end of study outcomes decode by researcher. 2 urticaria. Intervention 1: Intervention group: Herbal product based on barley seeds (Hordeum vulgare) in a dose of 15 grams in 2 doses for 4 weeks is prescribed. The herbal product contains an aqueous extract of barley seeds which is converted into powder during the spray-drying process and presented to the patient.Patients also receive the common urticaria drug, Foxofenadine 180 mg twice daily. Intervention 2: Control group: Provide placebo powder 15 mg twice a day + Faxophenadine 180 mg twice a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A decision will be made at the end of the study
public Shahin Saeidinejat
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 0098513884892 Saeedish1@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Derakhshan
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98513884892 DerakhshanAR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with chronic spontaneous urticaria, aged 18 to 60 years do not have autoimmune disease or immunodeficiency wish to participate in the study 18 years 60 years Both pregnancy Previous hypersensitivity to the drug or any of the compounds present in the herbal medicinal product L50 Urticaria Treatment - Drugs Treatment - Drugs Intervention group: Herbal product based on barley seeds (Hordeum vulgare) in a dose of 15 grams in 2 doses for 4 weeks is prescribed. The herbal product contains an aqueous extract of barley seeds which is converted into powder during the spray-drying process and presented to the patient.Patients also receive the common urticaria drug, Foxofenadine 180 mg twice daily. Control group: Provide placebo powder 15 mg twice a day + Faxophenadine 180 mg twice a day Detect the effect of barley extract on clinical symptoms of CSU patients. Timepoint: At the beginning of the intervention and 4 weeks after taking the drug. Method of measurement: International Urticaria Registration Questionnaire. Urticaria clinical symptoms score. Timepoint: At the beginning of the intervention and 4 weeks later. Method of measurement: Urticaria Activity score Questionnaire. Quality of life of chronic urticaria patients. Timepoint: At the beginning of the intervention and 4 weeks later. Method of measurement: score of Chronic Urticaria Quality of Life questionnaire. Relapse of patients' clinical symptoms. Timepoint: At the beginning of the intervention and 4 weeks later. Method of measurement: Urticaria Control Test. Mashhad University of Medical Sciences Approved 2021-02-09 School of Medicine- Mashhad University of Medical Sciences - Biomedical Research Ethics Committee Azadi Squair- Kalantary Street Mashhad Razavi Khorasan Iran (Islamic Republic of)