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IRCT20220205053947N1 IRCT 2022-03-17 Shiraz University of Medical Sciences Tranexamic acid in chronic urticaria Assessing the safety and efficacy of Tranexamic Acid and cetirizine versus Cetirizine alone in relieving the symptoms of Chronic Urticaria; a triple-blind Randomized Clinical Trial 2022-04-04 anticipated 80 Complete https://irct.ir/trial/62311 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation will be achieved by a computer system by the website www.randomization.com. the website randomly allocates the patients (introduced as numbers) to two groups as A and B. allocation concealment will be achieved using dark envelopes. The method will be simple randomization, Blinding description: After obtaining an informed consent form the patients or their legal guardians, the patients will be divided to groups A and B. one of the groups will receive Cetirizine tabs and Tranexamic Acid capsules, while the other group will receive a Cetirizine tabs and capsules containing placebo made by school of Pharmacy of Shiraz University of Medical Sciences (Cetirizine tabs will be bought by the patients as they are the mainstay of treatment is urticaria). Neither the patients nor the professors will know about the contents of the capsule and the study will be double-blinded. Only the Pharmacist will be informed of the ingredients of each capsule. 2-3 chronic urticaria. Intervention 1: Intervention group: will receive Cetirizine 10mg PO BiD for two weeks and Tranexamic Acid 500mg PO Q6h for two weeks. Intervention 2: Control group: will receive Cetirizine 10mg PO BiD for two weeks and placebo capsule PO Q6h for two weeks. Yes - There is a plan to make this available What will be shared: The results of the study and the data will be available to other researchers who were not involved in this study for further studies upon reasonable request. When: the data will be available in 6 months. To whom: the data will be available to academic institutes upon reasonable request. Conditions: the data will be available to academic institutes upon reasonable request. Where to obtain: the data will be available via email. How to obtain: the request should be sent to askariaida@gmail.com and the reason should be explained. Comments:
public Aida Askarisarvestani
Department of Pediatrics, Namazee hospital, Namazee Sq., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 askariaida@gmail.com Shiraz University of Medical Sciences scientific Seyed Hesamedin Nabavizadeh
Department of Pediatrics, Namazee hospital, Namazee Sq., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 drhesamnabavi@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients older than 12 years old Patients with spontaneous chronic urticaria, according to the criteria of the European Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an association of the following symptoms: urticarial eruptions and/or recurrent angioedema for at least 6 weeks 12 years no limit Both Urticaria associated with a specific systematic disease including cutaneous and systemic mastocytosis Urticarial vasculitis Autoinflammatory diseases associated with cryopyrin Bradykinin angioedema Isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria Presence of a contraindication to Tranexamic Acid and to Cetirizine such as any history of thromboembolic events as pulmonary thromboembolism and deep vein thrombosis Coagulopathy. Unwillingness of the patients or their legal guardians to participate in the study L50.8 Other urticaria Treatment - Drugs Treatment - Drugs Intervention group: will receive Cetirizine 10mg PO BiD for two weeks and Tranexamic Acid 500mg PO Q6h for two weeks Control group: will receive Cetirizine 10mg PO BiD for two weeks and placebo capsule PO Q6h for two weeks Chronic Urticaria Quality of Life. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: CU-QoL questionnaire. Severity of Chronic Urticaria. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: UAS7 questionnaire. Level of D-dimer. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2022-02-14 Ethics committee of Shiraz University of Medical Sciences Department of Pediatrics, Namazee hospital, Namazee Sq., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)