Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Study Overview
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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.

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).

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

Conditions
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End-Stage Renal Disease, Pruritus

Intervention / Treatment
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* Drug: Wheat
* Drug: Fumaria


Participation Criteria
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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 Exclusion Criteria: Liver disease Respiratory disease Dermatological disease Hemoglobin less than 10 Cholestasis Malignancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Wheat<br>Placebo capsule/ 2 capsule 3 times per day | Drug: Wheat<br>* 3 times a day each time 2 capsules before eating meal for 8 weeks.<br>|
| Active Comparator: Fumaria<br>Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day. | Drug: Fumaria<br>* 3 times a day each time 2 capsules before eating meal for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Interferon-gamma level |  | 4 months | 
| Serum IL-4 level |  | 4 months | 
| Serum high-sensitive C reactive protein (hs-CRP) |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pruritus, End-Stage Renal Disease