Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Phase 2

Completed

• Conditions: Pruritus; End-Stage Renal Disease
• Interventions: Drug: Wheat; Drug: Fumaria

• Registration Number: NCT02671162
• Lead Sponsor: Shiraz University of Medical Sciences

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).

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-10
• Status Verified: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-01
• Last Update Submitted: 2016-02-01
• Study First Posted: 2016-02-02
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wheat	Wheat	Placebo capsule/ 2 capsule 3 times per day
Fumaria	Fumaria	Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.

Primary Outcome Measures

Name	Time	Method
Severity of Pruritis as measured by a visual analogue scale (VAS)	3 months	A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.

Secondary Outcome Measures

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