The recent study aims to determine the effect of aloe vera gel to improving the quality of their lives of pruritus in hemodialysis patients . This study will be done in Valiasr Hospital of Arak with sample size of 64people contains 32 people in intervention group and 32 people in control group. In this study, the researchers and data monitoring committee Will be blinded . The samples placed into two groups using table of random numbers: intervention group and control group. In this study, Clinical trial phase was not applicable. Inclusion criteria: a desire to participate in the study, at least 3 months of hemodialysis, continuous hemodialysis three times a week, a history of itching for at least 2 weeks, no disease causing itching (according to the doctor), a full awareness, lack of physical disability or a mental illness known as severe anxiety and depression, lack of using anti-itch drugs. Exclusion criteria: Patients who for any reason do not wish to continue participating in the study, if the patient uses anti itch medications during the intervention. In this study, 5-D Pruritus scale will be used. Intervention: For intervention group Aloe Vera gel will be used 2times in a day for 1 month: 1)ّin day after hemodialysis 2)before night sleep. The severity of itch will be measured at the beginning of intervention and one month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051411940N3
Registration date:2016-05-04, 1395/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-04, 1395/02/15
Registrant information
Name
Azam Malek Hoseini
Name of organization / entity
Arak University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1226 7892
Email address
m.saeedi@arak.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloe vera gel on pruritus severity of Hemodialysis patients
Public title
The effect of Aloe vera gel on pruritus severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a desire to participate in the study, at least 3 months of hemodialysis, continuous hemodialysis three times a week, a history of itching for at least 2 weeks, no disease causing itching (according to the doctor), a full awareness, lack of physical disability or a mental illness known as severe anxiety and depression, lack of anti-itch drugs.
Exclusion criteria: Patients who for any reason do not wish to continue participating in the study, if the patient uses anti itch medications during the intervention .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples using table of random numbers placed in two groups intervention group and control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Valiasr Hospital, Alam al-Hoda Street, Emam khomeini St, Arak
City
Arak
Postal code
3848176941
Approval date
2013-10-28, 1392/08/06
Ethics committee reference number
92-157-6
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.3
ICD-10 code description
Kidney damage with moderately decreased GFR (30-59 mL/min)
Primary outcomes
1
Description
The severity of itch
Timepoint
Initiation of intervention and one month after intervention
Method of measurement
(5-D Pruritus scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For intervention group Aloe vera gel will be used 2times in a day for 1 month: 1)ّFirst time in day after hemodialysis 2)Second time befor night sleep.
Category
Treatment - Drugs
2
Description
Control group: Control group will be receive routine cares and no specific drugs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Azam Malek Hoseni
Street address
Valiasr Hospital,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Ms. Mir-Hosseini
Street address
Arak University of Medical Sciences, Alamolhoda St,Arak
City
Arak
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Azam Malek Hoseini
Position
Educator
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamolhoda St,Arak
City
Arak
Postal code
3817834467
Phone
+98 86 3226 7892
Fax
+98 86 3417 3639
Email
malekhoseni.aram@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Malek Hoseini
Position
Educator
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamolhoda St,Arak
City
Arak
Postal code
3817834467
Phone
+98 86 3226 7892
Fax
+98 86 3417 3524
Email
malekhoseni.aram@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Malekhoseini
Position
Educator
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamolhoda St,Arak
City
Arak
Postal code
3817834467
Phone
+98 86 3226 7892
Fax
Email
malekhoseni.aram@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)