Clinical trial NCT02671162: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-Stage Renal Disease
Pruritus
Keywords: Pruritus
End-Stage Renal Disease
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Severity of Pruritis as measured by a visual analogue scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Serum Interferon-gamma level
timeFrame: 4 months
measure: Serum IL-4 level
timeFrame: 4 months
measure: Serum high-sensitive C reactive protein (hs-CRP)
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Jamshid Roozbeh, MD
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Pouya Faridi, PhD
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences
name: Rahimeh Akrami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.