Protocol summary

Summary
The aim of this study was to evaluate the topical effect of coconut oil on pruritus, compared with placebo, in patient on hemodialysis. This randomaized clinical trail was performed on 100 patients on hemodialysis who had pruritus score above 3 and treatment with hemodialysis 3-5 hour, thrice in week. Alergy to coconut oil and access systematic disease and hospitalization was exclusion critria from search (15 patient exclude of study). The patients were divided randomize into two groups, one groups received coconut oil 5 cc on local of body with itching and other groups placebo, twice a day for 4 weeks. Pruritus score were analyzed and compared in two groups at week 0,2,4.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061034431N1
Registration date: 2017-07-23, 1396/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
banafsheh nezhadi
Name of organization / entity
shaheed beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 22258992
Email address
nezhadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical coconut oil therapy for uremic pruritus in patients on hemodialysis
Public title
effect of coconut oil on treatment pruritus of hemodialysis patient
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria :age 18 until 65 -pruritus score up to 3 - without skin diseases and hepatic disease- no receipt of anti pruritus drug- dialysis effeciency up to1/2 --use of polysolfan filter-- history of dialysis up to six month exclusion criteria: sensitive to coconut oil--systematic diseases ---admit to hospital
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 85
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of shaheeh beheshti university
Street address
velengak
City
tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR-SBMU.RETECH.REC.1395.216

Health conditions studied

1

Description of health condition studied
end stage renal disease on hemodialysis
ICD-10 code
18.5
ICD-10 code description
Chronic uraemiaEnd stage kidney disease:•in allograft failure

Primary outcomes

1

Description
number of dialysis in a week
Timepoint
start of research
Method of measurement
demografic questionaire

2

Description
duration of treatmen with dialysis
Timepoint
start of research
Method of measurement
demografic questionaire

3

Description
pruritus
Timepoint
start of research, after two and four week of intervention
Method of measurement
VAS scale(visual analoge scale)

Secondary outcomes

empty

Intervention groups

1

Description
massage 5cc coconut oil two time per day on local of body with itching, except fistula location for 4 weeks .
Category
Rehabilitation

2

Description
massage of 5 cc paraffin two time per day on local of body with itching for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
shaheed taleganee hospital
Full name of responsible person
banafsheh nezhadi
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
shohadae tagresh hospital
Full name of responsible person
banafsheh nezhadi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
chancellor for reacherch of shaheed beheshti university
Full name of responsible person
Dr.ali zeaee
Street address
shaheed beheshtee university
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
chancellor for reacherch of shaheed beheshti university
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
shaheeh beheshti university
Full name of responsible person
banafsheh nezhadi
Position
master of science
Other areas of specialty/work
Street address
mofid hospital
City
TEHRAN
Postal code
Phone
+98 21 2225 8992
Fax
Email
b.nezhadi79@gmail.comnezhadi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shaheeh beheshti university
Full name of responsible person
banafsheh nezhadi
Position
Master of science student in nursing
Other areas of specialty/work
Street address
mofid hospital
City
Tehran
Postal code
Phone
00892122258992
Fax
Email
nezhadi@sbmu.ac.irb.nezhadi79@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
shaheeh behashti university
Full name of responsible person
banafsheh nezhadi
Position
master of science
Other areas of specialty/work
Street address
mofid hospital
City
tehran
Postal code
Phone
+98 21 2225 8992
Fax
Email
b.nezhadi79@gmail.comnezhadi@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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