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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
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring uremia, pruritus, oliva-omega 3

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 31, 2007
    Last Updated
    October 5, 2011
    Sponsor
    Assaf-Harofeh Medical Center
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    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

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    Treatment of Uremic Pruritus by Olive-omega 3 Ointment

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