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Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Primary Purpose

End-Stage Renal Disease, Pruritus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Wheat
Fumaria
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Pruritus, End-Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemodialysis patients
  • Suffering from pruritus for at least 6 weeks
  • Have not responded to other drugs
  • visual analogue scale (VAS) equal or more than 4

Exclusion Criteria:

  • Liver disease
  • Respiratory disease
  • Dermatological disease
  • Hemoglobin less than 10
  • Cholestasis
  • Malignancies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Wheat

    Fumaria

    Arm Description

    Placebo capsule/ 2 capsule 3 times per day

    Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.

    Outcomes

    Primary Outcome Measures

    Severity of Pruritis as measured by a visual analogue scale (VAS)
    A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.

    Secondary Outcome Measures

    Serum Interferon-gamma level
    Serum IL-4 level
    Serum high-sensitive C reactive protein (hs-CRP)

    Full Information

    First Posted
    January 29, 2016
    Last Updated
    February 1, 2016
    Sponsor
    Shiraz University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02671162
    Brief Title
    Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus
    Official Title
    Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
    Detailed Description
    Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End-Stage Renal Disease, Pruritus
    Keywords
    Pruritus, End-Stage Renal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Wheat
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo capsule/ 2 capsule 3 times per day
    Arm Title
    Fumaria
    Arm Type
    Active Comparator
    Arm Description
    Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.
    Intervention Type
    Drug
    Intervention Name(s)
    Wheat
    Intervention Description
    3 times a day each time 2 capsules before eating meal for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Fumaria
    Intervention Description
    3 times a day each time 2 capsules before eating meal for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Severity of Pruritis as measured by a visual analogue scale (VAS)
    Description
    A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Serum Interferon-gamma level
    Time Frame
    4 months
    Title
    Serum IL-4 level
    Time Frame
    4 months
    Title
    Serum high-sensitive C reactive protein (hs-CRP)
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hemodialysis patients Suffering from pruritus for at least 6 weeks Have not responded to other drugs visual analogue scale (VAS) equal or more than 4 Exclusion Criteria: Liver disease Respiratory disease Dermatological disease Hemoglobin less than 10 Cholestasis Malignancies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jamshid Roozbeh, MD
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Pouya Faridi, PhD
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rahimeh Akrami, PhD
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    21372257
    Citation
    Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3.
    Results Reference
    background
    PubMed Identifier
    16249205
    Citation
    Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
    Results Reference
    background
    PubMed Identifier
    33283264
    Citation
    Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
    Results Reference
    derived
    Links:
    URL
    https://www.nlm.nih.gov/medlineplus/
    Description
    Itching, Kidney Diseases, Kidney Failure
    URL
    http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
    Description
    Fumaria

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    Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

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