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IRCT20190825044613N1 IRCT 2019-12-15 Iran University of Medical Sciences Effect of Probiotic in reducing urticaria and pruritus in people with chronic urticaria Comparison of the effectiveness of probiotic and antihistamine therapy with antihistamine therapy alone in reducing the number of urticaria and pruritus in chronic urticaria patients 2019-10-23 anticipated 42 Complete https://irct.ir/trial/42273 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two main groups after first visit. Patients with odd number in the list are included in to group 1 and patients with even number are included in group 2. 1 Hives. Intervention 1: Intervention group: For the first group of patients, treatment includes only antihistamines.Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. In addition, two lactocare capsules are prescribed too which are containing two probiotics. Intervention 2: Control group: The second group of patients only received antihistamines. Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. Yes - There is a plan to make this available What will be shared: All potential data can be shared after publication of result When: At the end of data collection period until the publication of results To whom: Only doctors and medical students Conditions: Only when people intend to research about this topic Where to obtain: To the scientific and executive members of the project How to obtain: Communicate with the scientific and executive authorities of the project - Submiting their official letter from research centers -using the patient's information only at designated center - Submiting their final report obtained by information. Comments:
public Shokoufeh Sharifi
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 912 343 1408 sharifishokoufeh67@gmail.com Iran University of Medical Sciences scientific Shokoufeh Sharifi
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 6435 2528 sharifishokoufeh67@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) For at least two days of week patients must have urticaria lesions and these lesions must remain for at least 6 weeks. Age between 18 to 45 years old 18 years 45 years Both Serious comorbidities (such as malignancies, mental illness, hepatitis, endocrine or other acute and chronic systemic diseases) Taking any drug other than antihistamines Patients with vasculitis Patients with urticaria due to autoimmune diseases A history of severe gastrointestinal diseases such as indigestion and malabsorption Patients taking corticosterone for any reason A history of asthma and allergies in the patients and their first degree relatives Patients with severe mental problems L50.9 Urticaria, unspecified Treatment - Drugs Treatment - Drugs Intervention group: For the first group of patients, treatment includes only antihistamines.Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. In addition, two lactocare capsules are prescribed too which are containing two probiotics. Control group: The second group of patients only received antihistamines. Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. Itching severity. Timepoint: first visit - 8 Week after treatment. Method of measurement: Questionnaire and visit. Urticaria activity score over 7 days (UAS7). Timepoint: first visit -- 8 Week after treatment. Method of measurement: Questionnaire and visit. Number of hives. Timepoint: first visit - 8 Week after treatment. Method of measurement: Questionnaire and visit. Quality of Life. Timepoint: first visit snd 8 Week after treatment. Method of measurement: dermatology Quality Life Index. Complications. Timepoint: 8 Week after treatment. Method of measurement: interview. Tolerance of treatment and satisfaction. Timepoint: 8 Week after treatment. Method of measurement: interview. Iran University of Medical Sciences Approved 2019-02-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)