Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02671162

Enrollment

Registered

2016-02-02

Start date

2015-07-31

Completion date

2016-01-31

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease, Pruritus

Keywords

Pruritus, End-Stage Renal Disease

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).

Interventions

DRUGWheat

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

DRUGFumaria

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026