Some studies showed that fatty acids deficiency were related to pruritus in hemodialysis patients. Aim of this study is compare the effect of topical and oral flaxseed-oil on pruritus severity of hemodialysis patients. Patients with history of at least 6 months hemodialysis; three times hemodialysis in a week for 3-4 hours in each session; phosphorous level below 6 mg/dl and parathyroid hormone level below 600 pg/ml will be selected. Patients who are treated with warfarin, hemoglobine level below 10gr/dl and pruritus related to other disorders are excluded. Eligible patients randomly assigned in three groups. Patients in group one are received routine care. In group two, patients are received oral flaxseed-oil 1 gr three times a day for 6 weeks. Patients in group three are received topical flaxseed-oil 5 cc in two times a day for 6 weeks. Severity of pruritus in three groups are compared with each others.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602116481N9
Registration date:2016-06-16, 1395/03/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-06-25, 1395/04/05
Expected recruitment end date
2017-12-26, 1396/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of topical and oral flaxseed-oil on pruritus severity of hemodialysis patients.
Public title
Comparing effect of topical and oral flaxseed-oil on pruritus severity of hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least 6 month history of hemodialysis; hemodialysis for three times a week for 3-4 hours; phosphor of serum below 6 mg/dl; parathyroid hromone level below 600 pg/ml.
Exclusion criteria: Pruritus realted to hepatic and metabolic disorders; systemic disorders such as malignancy, hepatitis, cholestasis; hemoglobin level below 10g/dl; warfarin therapy; renal transplantation during study; allergy to oils.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.SEMUMS.REC.1395.24
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Pruritus
Timepoint
Every 2 weeks for 6 weeks
Method of measurement
The 5-D itch scale
Secondary outcomes
1
Description
Hemoglobine
Timepoint
Every 3 weeks for 6 weeks
Method of measurement
Complete blood count
Intervention groups
1
Description
Topical flaxseed-oil 5cc two times a day for 6 weeks.
Category
Treatment - Other
2
Description
Oral flaxeed-oil 1gr three times a day for 6 weeks
Category
Treatment - Other
3
Description
Routine cares
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Soodeh hospital
Full name of responsible person
Rahimeh Nabavi
Street address
Islam-shahr Vavan town
City
Islam-shahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidy-pour
Street address
Vice-chancellor, Semnan University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 233354191
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 233354191
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)