Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.

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Detailed Description

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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).

Conditions

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End-Stage Renal Disease Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Wheat

Placebo capsule/ 2 capsule 3 times per day

Group Type PLACEBO_COMPARATOR

Wheat

Intervention Type DRUG

3 times a day each time 2 capsules before eating meal for 8 weeks.

Fumaria

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

Group Type ACTIVE_COMPARATOR

Fumaria

Intervention Type DRUG

3 times a day each time 2 capsules before eating meal for 8 weeks.

Interventions

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Wheat

3 times a day each time 2 capsules before eating meal for 8 weeks.

Intervention Type DRUG

Fumaria

3 times a day each time 2 capsules before eating meal for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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