The study employed a randomized, comparative, doubled-blind design. Randomization was performed by using a random number table, and the patients (50 known cases of end-stage renal disease treated with hemodialysis, aged 18-60 years) were randomly allocated to one of the two arms of the study: study group (oral nicotinamide 500 mg two times a day) or control group (placebo). The placebo was formulated by a pharmacist to have similar base with the drug but not containing the active ingredient. The same tablet to make both tablets to look physically identical. The used medications were not revealed to their physicians. The patients instructed to drink the medication two times a day for 4 week and were prohibited to use any other treatments for pruritus during the study but they were allowed to use their routine medications, e.g. antihypertensive agents. Each Patient was visited five times in total, one time at the beginning of treatment and weekly for one month. At each visit patients were oriented on how to interpret their pruritus based on Visual Analogue Scale (VAS) (0: no pruritus and 5: the worst pruritus).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202068940N1
Registration date:2012-04-13, 1391/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-13, 1391/01/25
Registrant information
Name
Ahmad Khazanee
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 2535
Email address
khazani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of antipruritic effect of oral nicotinamide in uremic patients
Public title
Investigation of antipruritic effect of oral nicotinamide in uremic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known cases of end-stage renal disease patients treated with hemodialysis; ages between 18 and 60 years; At least 6 weeks history of pruritus; no systemic or topical treatment for the pruritus. Exclusion criteria: a known hypersensitivity to nicotinamide; suffering from other known skin diseases, liver disorders, metabolic disorders, any other condition except for CRD causing pruritus; any serious systemic disease; Usage of antihistamines or other anti-pruritus drugs in the last three months.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
ETH-112
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
C00-D48
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Attenuation of uremic pruritus
Timepoint
Four weeks
Method of measurement
By using a traditional Visual Analogue Scale (VAS) and a modified questionnaire method (pruritus score)
Secondary outcomes
empty
Intervention groups
1
Description
placebo
Category
Placebo
2
Description
oral nicotinamide 500 mg two times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Ward, Ahvaz Imam Hospital
Full name of responsible person
Ahmad Khazanee
Street address
Imam Hospital, Jundishapur University of Medical Sciences
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Ahmad Khazanee
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Imam Hospital
City
Aahvaz
Postal code
Phone
+98 61 1222 4344
Fax
Email
khazani.a@ajums.ac.ir , dr_khazani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Ahmad Khazanee
Position
Resident of Dermatolgy
Other areas of specialty/work
Street address
Imam Hospital
City
Ahvaz
Postal code
Phone
+98 61 1292 1837
Fax
Email
khazani.a@ajums.ac.ir , dr_khazani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)