Effects of three therapeutic methods (oatmeal (Avena Sativa) and diluted vinegar sponge bath and Routine Protocol) in reducing uremic pruritus in hemodialysis patients referred to the dialysis center of Birjand s’ Valiasr hospital - (2013)
Objectives:
The current study will be conducted to compare the effects of three methods (oatmeal (Avena Sativa), diluted vinegar sponge bath and Routine Protocol) on uremic pruritus. Avena Sativa lotion (Avena) is an anti-itch and a treatment product which has few complications but its effect on pruritus in patients with renal failure has not been well elucidated. Diluted vinegar is a safe, cheap and available liquid for all patients in comparison with highly complicated and expensive routine chemical treatment protocol.
Design:
This study is randomized cross-over clinical trial
Setting and conduct:
a) Participants:
This study will be conducted in hemodialysis patients referred to the dialysis center of Birjand s’ Valiasr hospital, the patients will be selected based on the study objectives via census method.
Inclusion criteria consist of: at least 2 weeks history of Uremic pruritus; at least twice/ Tree times hemodialysis in week and Exclusion criteria : Severe side effects like an allergic reaction to the vinegar or oats
b) Intervention:
The subjects will be allocated to three groups randomly and after the wash out period each group will be treated with diluted vinegar, Avena Sativa lotion twice per day for two weeks, as well as routine protocol in this period after the wash out period, treatments will be changed in three groups cross overly.
c) main outcome measures:
Pruritus severity will be measured via a questionnaire and visual analog scale (VAS) that will be filled before and after each intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021912525N1
Registration date:2013-03-16, 1391/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Samaneh Nakhaee
Name of organization / entity
Birjand Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 3041
Email address
nakhaee67@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Birjand Medical Sciences University
Expected recruitment start date
2013-03-10, 1391/12/20
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of three therapeutic methods (oatmeal (Avena Sativa) and diluted vinegar sponge bath and Routine Protocol) in reducing uremic pruritus in hemodialysis patients referred to the dialysis center of Birjand s’ Valiasr hospital - (2013)
Public title
The comparison of the effects of three therapeutic methods (oatmeal (Avena Sativa) , diluted vinegar sponge bath and Routine Protocol) in reducing uremic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be referred to the dialysis center of Birjand Valiasr hospital؛ patients with renal failure (glomerular filtration rate less than60 ml/min for 3 months approved by a specialist)؛ with at least twice/ Tree times hemodialysis in week؛ they must be experienced Uremic pruritus at least for 2 weeks؛ They must be don’t have pruritus due to Dermal or non Dermal diseases.
The absence of liver problems؛ Pregnancy and lactation؛ as well as acute inflammatory lesions of the skin؛ No known history of allergy were the other inclusion criteria.
exclusion criteria:
Unwillingness to continue participation in the study؛ Severe side effects like an allergic reaction to the vinegar or oats؛ Renal transplantation before end of therapy؛ Dyeing or emigration were identified as exclusion criteria.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand Medical Sciences University ethics committee
Street address
Gafari street, Birjand University of Medical Science
City
Birjand
Postal code
Approval date
2013-02-17, 1391/11/29
Ethics committee reference number
14-11-1391
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
2
Description of health condition studied
pruritus
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Uremic pruritus
Timepoint
Before and after each intervention and before dialysis
Method of measurement
Demographic checklist and pruritus questionnaire and Visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, patients will be treated by Avena lotion (made in Espanol company in Spain) twice per day for two weeks. After Wash out period the second treatment period will be continued by diluted vinegar6%(30 ml vinegar/500ml water) twice per day for two weeks and after second Wash out period ,the subjects will receive routine protocol for two weeks.
Category
Treatment - Drugs
2
Description
In the second group, patients will be treated by diluted vinegar 6% (30 ml vinegar/500ml water) twice per day for two weeks. After Wash out period second treatment period will be continued by routine protocol for two weeks and after Wash out period, the subjects will receive Avena lotion (made in Espanol company in Spain) twice per day for two weeks.
Category
Treatment - Drugs
3
Description
In the third group, patients will be treated by routine protocol for two weeks. After Wash out period second treatment period will be continued by Avena lotion (made in Espanol company in Spain) twice per day for two weeks and after Wash out period ,the subjects will receive diluted vinegar 6%(30 ml vinegar/500ml water) twice per day for two weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Ward in Valiasr hospital, Birjand
Full name of responsible person
Dr Jamile Morshedi
Street address
Gafari street, Valiasr hospital
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand Medical Sciences University, Vice Chancellor for Research
Full name of responsible person
Gholamreza Sharifzadeh
Street address
Gafari street, Birjand University of Medical Science
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand Medical Sciences University
Full name of responsible person
Samaneh Nakhaee
Position
Master Student in Nursing
Other areas of specialty/work
Street address
Gafari street, Birjand University of Medical Science, School of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
nakhaee67@bums.ac.ir;nakhaee38@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand Medical Sciences University
Full name of responsible person
Dr Ahmad Nasiri
Position
PHD in Nursing Faculty of Birjand Medical Sciences University
Other areas of specialty/work
Street address
Gafari street, Birjand University of Medical Science, School of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
+98 56 1444 0556
Email
nasiri2006@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand Medical Sciences University
Full name of responsible person
Samaneh Nakhaee
Position
Master Student in Nursing
Other areas of specialty/work
Street address
Gafari street, Birjand University of Medical Science, School of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
nakhaee67@bums.ac.ir;nakhaee38@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)