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IRCT20210407050878N1 IRCT 2021-06-29 Iran University of Medical Sciences Effect of naltrexone in chronic urticaria Effect of naltrexone in treatment of chronic urticaria: double-blinded randomized clinical trial 2021-07-21 anticipated 62 Complete https://irct.ir/trial/56435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is done using the Sealedenvelope.com Site with block size of 4 and considering a unique code for each participant. To hide random allocation, the drug for each person is placed in a package whose envelope is opaque and a unique code is affixed to it, Blinding description: In this study, blinding is performed for the following levels. Patient: Placebo is used which is similar to the main drug in terms of color, shape, appearance and smell. The received intervention is specified by the code and the researcher is not aware of the codes. N/A Urticaria. Intervention 1: Intervention group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Nalteroxone 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks. Intervention 2: Control group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Placeco 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks. Yes - There is a plan to make this available What will be shared: All collected data can be shared after deidentifying participants When: Data will become available 6 months after publication To whom: Individual participant data only available for people working in academic institutions. Conditions: - Where to obtain: Dr. Bakrani Balani Vahid email address bakranibalani.v@iums.ac.ir How to obtain: The data will be sent on month after recieving the e-mail. Comments:
public Vahid Bakrani Balani
Hazrat Rasool Hospital, Niayesh St, Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4933 bakranibalani.v@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Hasan Bemanian
Hazrat Rasool Hospital, Niayesh St., Sattarkhan Ave., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4933 mh.bemanian@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of chronic urticaria based on clinical criteria Lack of response to standard treatment Patients of both males and females Age over 12 years 12 years no limit Both Pregnancy Breast feeding Allergy to naltrexone Substance abuse L50 Urticaria Treatment - Drugs Placebo Intervention group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Nalteroxone 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks. Control group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Placeco 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks. Itching Score based on UAS7 (Urticaria Activity Score7). Timepoint: Itching score based on UAS7 (Urticaria Activity Score7): During the week before beginning intervention, during the second week of intervention, during the fourth week of intervention. Method of measurement: Based on UAS7 (Urticaria Activity Score7). Urticaria Score based on UAS7 (Urticaria Activity Score7). Timepoint: Urticaria score based on UAS7 (Urticaria Activity Score7): during the week before beginning intervention, during the second week of intervention, during the fourth week of intervention. Method of measurement: Based on UAS7 (Urticaria Activity Score7). Itching score based on VAS (Visual Analogue Scale). Timepoint: Before intervention, end of the second week of intervention, end of the fourth week of intervention. Method of measurement: Based on VAS (Visual Analogue Scale). Quality of life based on DLQI (Dermatologic Life Quality Index). Timepoint: Before intervention, end of the second week of intervention, end of the fourth week of intervention. Method of measurement: Based on DLQI (Dermatologic Life Quality Index). Iran University of Medical Sciences Approved 2021-05-10 Ethics Committee of Faculty of Medicine, Iran University of Medical Sciences Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Next to Milad Tower Tehran Tehran Iran (Islamic Republic of)