Treatment of Uremic Pruritus by Olive-omega 3 Ointment
Primary Purpose
Uremic Pruritus
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
application of ointment (olive-omega 3 ointment)
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus focused on measuring uremia, pruritus, oliva-omega 3
Eligibility Criteria
Inclusion Criteria:
- Hemodialysis patients which have treated at least 3 months
Exclusion Criteria:
- Dermatologic diseases
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01447693
First Posted
December 31, 2007
Last Updated
October 5, 2011
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01447693
Brief Title
Treatment of Uremic Pruritus by Olive-omega 3 Ointment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background.
Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis.
The pathogenesis of uremic itch remains unclear. Several theories have been proposed like dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.
Many treatment modalities have been tried to reduce uremic pruritus, however , the majority of them produced only temporary improvement. Therefore , every new therapeutic option for uremic pruritus is desirable.
This study will undertaken to evaluate the efficacy of a cream which included olive oil and omega-3 fatty acids.
Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.
The product is unique and based on patented technology developed by the Technion Research and Development Foundation in Haifa.
Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty acids that are vital for its proper functioning and help in the skin recovery. Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing water retention in the upper layer of the skin.
When applied on clean skin , the product is quickly absorbed , producing a sensation of relief within a short time period. Treatment can be repeated as often as required with no limitations and its use is not contraindicative of any other medical treatment.
Patients and Methods.
About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in the study.
All patients will undergo dermatologic examination. All patients will be score by intensity of itching according to 3-point scale , as follows:
- patches of fine , powdery scales
- moderate scaling with beginning cracks
- intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for 50% of body and Vaseline ointment for the second one. The treatment will repeated twice daily for two weeks.
At the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:
very good
good
poor
At the same time global agreement of the patients will evaluate according to the following scale :
- very satisfactory
- satisfactory 3- poorly satisfactory.
Statistical analysis will be performed by use of Wilcoxon test .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
uremia, pruritus, oliva-omega 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
application of ointment (olive-omega 3 ointment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemodialysis patients which have treated at least 3 months
Exclusion Criteria:
Dermatologic diseases
12. IPD Sharing Statement
Learn more about this trial
Treatment of Uremic Pruritus by Olive-omega 3 Ointment
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