A Phase 2 interventional study of Wheat and Fumaria in End-Stage Renal Disease and Pruritus, sponsored by Shiraz University of Medical Sciences. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-02.
Sponsored by Shiraz University of Medical Sciences · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Placebo capsule/ 2 capsule 3 times per day
Drug: Wheat
Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.
Drug: Fumaria
3 times a day each time 2 capsules before eating meal for 8 weeks.
3 times a day each time 2 capsules before eating meal for 8 weeks.
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.
Time frame: 3 months
Serum Interferon-gamma level
Time frame: 4 months
Serum IL-4 level
Time frame: 4 months
Serum high-sensitive C reactive protein (hs-CRP)
Time frame: 4 months
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences