Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

End-Stage Renal Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671162
• Other study ID #: IRCT2015080110410N2
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2016
• Last updated: February 1, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Pruritus

Intervention

Drug:
• Wheat
3 times a day each time 2 capsules before eating meal for 8 weeks.
• Fumaria
3 times a day each time 2 capsules before eating meal for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

References & Publications (2)

Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3. — View Citation

Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stülten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. Epub 2005 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum Interferon-gamma level		4 months	No
Secondary	Serum IL-4 level		4 months	No
Secondary	Serum high-sensitive C reactive protein (hs-CRP)		4 months	No

External Links

•   Fumaria
•   Itching, Kidney Diseases, Kidney Failure