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Completed

NCT Number: NCT02671162

Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

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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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritus Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat

Drug

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

Fumaria

Drug

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

Primary outcomes

  1. Severity of Pruritis as measured by a visual analogue scale (VAS)

    Time frame: 3 months

    A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.

Secondary outcomes

  1. Serum Interferon-gamma level

    Time frame: 4 months

  2. Serum IL-4 level

    Time frame: 4 months

  3. Serum high-sensitive C reactive protein (hs-CRP)

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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