This study will conduct to compare oral Charcoal capsule with Aluminum Hydroxide Syrup effects on hemodialytic patients’ pruritus in Gorgans’ 5th Azar hospital. In this crossover clinical trail, 30 hemodialytic patients will select Gorgans’ 5th Azar hospital via convenience sampling method. Then the subjects randomly will allocate to two groups (n= 15 per group). Inclusion criteria consist of: at least 2 weeks history of Uremic pruritus; Having Moderate or severe pruritus {base on measurement of Pruritus scale (MPS) or Visual Analog Scale (VAS)}; At least 6 months history of hemodialysis; Tree times in week and four hours for each session. Exclusion criteria : have dermal or non dermal causer pruritus.
Each group receive oral charcoal capsule (6g daily in three doses) for two weeks as well as Aluminum Hydroxide syrup (30 cc; three times per day before each meal) for the same time (4 weeks intervention for groups). After 48 hours wash out period will replace treatments in two groups cross overly. Pruritus severity will be measured by visual analog scale (VAS) and measurement of pruritus scale (MPS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107317164N1
Registration date:2011-08-10, 1390/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-10, 1390/05/19
Registrant information
Name
Ali Abbasi
Name of organization / entity
Golestan medical Sciences university
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1664
Email address
abbasi_a@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Golestan medical Sciences university
Expected recruitment start date
2007-06-12, 1386/03/22
Expected recruitment end date
2008-07-12, 1387/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Oral charcoal capsule with Aluminum Hydroxide Syrup on pruritus in hemodialytic patients in Gorgan 5th – Azar hospital.
Public title
Effect of charcoal on uremic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 2 weeks history of Uremic pruritus; Having Moderate or severe pruritus {based on measurement of Pruritus scale (MPS) or Visual Analog Scale (VAS)}; At least 6 months history of hemodialysis; Tree time hemodialysis in week and four hours for each session.
exclusion criteria: Having Dermal or non Dermal Causer Pruritus
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan medical Sciences university ethics committee
Street address
Golestan medical sciences and health services university, Shast kola street, Gorgan
City
Gorgan
Postal code
Approval date
2007-06-12, 1386/03/22
Ethics committee reference number
129299/35
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N17-N19
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Uremic pruritus
Timepoint
Pre-intervention, after 2 weeks, post-intervention
Method of measurement
Visual analog scale (VAS) and measurement of pruritus scale (MPS)
Secondary outcomes
1
Description
Laboratory parameters
Timepoint
Pre-intervention, after 2 weekes, post intervention
Method of measurement
Serum
Intervention groups
1
Description
In the second group, subjects receive Aluminum Hydroxide syrup (30 cc; three times per day before each meal), for two weeks. Wash out period is 48 hours. In the second period treatment for tow weeks, use oral activated Charcoal capsule 6gr daily in three doses.
Category
Treatment - Drugs
2
Description
In the first group, Subjects receive oral activated Charcoal capsule 6gr daily in three doses, for two weeks. Wash out period is 48 hours. second period treatment (tow weeks), continue by Aluminum Hydroxide syrup (30 cc; three times per day before each meal).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dialysis ward in 5 Azar hospital, Gorgan
Full name of responsible person
Mis Asyeh Khalili
Street address
5 Azar hospital, 5 Azar street, Gorganو Iran
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan medical Sciences university, Vice chancellor for research
Full name of responsible person
Dr Arabi
Street address
Golestan medical sciences and health services university, Shast kola street, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan medical Sciences university, Vice chancellor for research
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
Golestan medical Sciences university
Full name of responsible person
Ali Abbasi
Position
Instructor & Master
Other areas of specialty/work
Street address
Faculty of paramedical, Golestan medical sciences and health services university, Shast kola street, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 1664
Fax
Email
abbasi_a@goums.ac.ir; abbasi_msn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan medical Sciences university
Full name of responsible person
Ali Abbasi
Position
Master in Medical-Surgical nursing
Other areas of specialty/work
Street address
Faculty of paramedical, Golestan medical sciences and health services university, Shast kola street, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 3630
Fax
Email
abbasi_a@goums.ac.ir; abbasi_msn@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan medical sciences university
Full name of responsible person
Ali Abbasi
Position
Master in Medical-Surgical nursing and member of science Golestan medical Sciences university
Other areas of specialty/work
Street address
Faculty of paramedical, Golestan medical sciences and health services university, Shast kola street, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 3630
Fax
Email
abbasi_a@goums.ac.ir; abbasi_msn@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)