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IRCT20170609034406N7 IRCT 2021-05-14 Ardabil University of Medical Sciences anti-pruritic effrcts of curcumin on refractory burn itching Evaluation of anti-pruritic effects of curcumin in treatment resistant burn patients 2021-06-22 anticipated 100 Complete https://irct.ir/trial/54335 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Permuted Block Randomization method will be used for assigning patients into control and treatment groups. In this study, there will be 25 blocks containing 4 patients allocated to treatment and the control group. Random numbers in this study will be given using the Excel software to determine blocks and study groups randomly. N/A Burn pruritus. Intervention 1: Intervention group:Intervention group (curcumin recipient) includes 50 patients who will receive two capsules of curcumin ( 40mg activing redient in each capsule ) daily by mouth for 3 months in addition to standard treatment of pruritus ( including antihistamines and gabaergic medications ). Intervention 2: Control group:The control group included 50 patients who will be treated by mouth for 3 months to standard treatment of pruritus including antihistamines and gabaergic medications . No - There is not a plan to make this available Justification or reason for not sharing IPD is Threre is no further information
public Afshin Gharekhani
Faculty of Pharmacy , Tabriz University of Medical Science , Golgasht Street
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5351 anqarekhani@yahoo.com Tabriz University of Medical Sciences scientific Afshin Gharekhani
Faculty of Pharmacy , Tabriz University of Medical Science , Golgasht street
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5351 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years ; Having itching after burn injury ; Ability to understand and sign consent form 18 years no limit Both Other causes of pruritus including renal failure ; Pregnancy; presence of any chronic active, uncontrolled or severe inflammatory disease ( such as autoimmune diseases, connective tissue disease, malignancy, HIV, liver disease and pulmonary disease) ;Breastfeeding ; involvement in other clinical trials ; malabsorption syndrome ; Bleeding disorders ( Including coagulopathies) or high risk for bleeding ;intake of a curcumin supplement or other supplements that affecting itching such as omega_3 in the recent month ; Intolerance or allergy to curcumin ; Receiving drugs that have an effect on inflammatory factors ( sach as corticosteroids or other immunosuppressive drugs, non-steroidal anti-inflammatory drugs, pentoxifylline) in the recent 6 weeks; Use of warfarin ; Abuse of alcohol and other substances that cause dependence. L29.8 Other pruritus Treatment - Drugs Treatment - Drugs Intervention group:Intervention group (curcumin recipient) includes 50 patients who will receive two capsules of curcumin ( 40mg activing redient in each capsule ) daily by mouth for 3 months in addition to standard treatment of pruritus ( including antihistamines and gabaergic medications ) Control group:The control group included 50 patients who will be treated by mouth for 3 months to standard treatment of pruritus including antihistamines and gabaergic medications . Pruritus score. Timepoint: Before starting the intervention, Six weeks after the intervention and at the end of the intervention period. Method of measurement: Standard questionnaire. Quality of life. Timepoint: Before starting the intervention, Six weeks after the intervention and at the end of the intervention. Method of measurement: Standard questionnaire. Ardabil University of Medical Sciences Approved 2020-06-08 Ethics Committee of Ardabil University of Medical Sciences Ardabil University of Medical Sciences complex , Daneshgah Square , End of Daneshgah street Ardabil Ardabil Iran (Islamic Republic of)