Evaluation of anti-pruritic effects of curcumin in treatment resistant burn patients
Design
Randomized controlled Clinical trial with parallel groups on 100 patients with burn pruritus .
Settings and conduct
This study will be conducted as a pilot study on 100 burn patients with refractory pruritus hospitalized in Sina Hospital of Tabriz University of Medical sciences after screening by inclusion and exclusion criteria
Participants/Inclusion and exclusion criteria
Age over 18 years ; Having itching after burn injury ; Ability to understand and sign consent form
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.
Intervention groups
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 ).
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 .
Main outcome variables
Pruritus score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N7
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-pruritic effects of curcumin in treatment resistant burn patients
Public title
anti-pruritic effrcts of curcumin on refractory burn itching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years ; Having itching after burn injury ; Ability to understand and sign consent form
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences complex , Daneshgah Square , End of Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR . ARUMS . REC . 1399.171
Health conditions studied
1
Description of health condition studied
Burn pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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 )
Category
Treatment - Drugs
2
Description
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 .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Haspital
Full name of responsible person
Afshin Gharekhani
Street address
Sina Educational and Medical Center, between Shahid Montazeri and Hafez intersections, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3549 8342
Email
anqarekhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Pourrashid
Street address
Ardabil University of Medical Sciences complex , Daneshgah Square , End of Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3352 2437
Fax
+98 45 3352 2197
Email
m.pourrashid@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
anqarekhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laya Alirezaei
Position
Pharmacy Student
Latest degree
Bachelor
Other areas of specialty/work
Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
alirezaeilaya@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Threre is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available