Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01447693
Status:
UNKNOWN
Last Update Posted:
2011-10-06
First Post:
2007-12-31
Brief Title:
Treatment of Uremic Pruritus by Olive-omega 3 Ointment
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 skins 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
1 - patches of fine powdery scales
2 - moderate scaling with beginning cracks
3 - 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
1 very good
2 good
3 poor
At the same time global agreement of the patients will evaluate according to the following scale
1 - very satisfactory
2 - satisfactory 3- poorly satisfactory
Statistical analysis will be performed by use of Wilcoxon test
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 skins 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
1 - patches of fine powdery scales
2 - moderate scaling with beginning cracks
3 - 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
1 very good
2 good
3 poor
At the same time global agreement of the patients will evaluate according to the following scale
1 - very satisfactory
2 - satisfactory 3- poorly satisfactory
Statistical analysis will be performed by use of Wilcoxon test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None