Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus
February 1, 2016 updated by: Rahimeh Akrami, Shiraz University of Medical Sciences
Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Wheat
Placebo capsule/ 2 capsule 3 times per day
|
3 times a day each time 2 capsules before eating meal for 8 weeks.
|
|
Active Comparator: Fumaria
Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.
|
3 times a day each time 2 capsules before eating meal for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum Interferon-gamma level
Time Frame: 4 months
|
4 months
|
|
Serum IL-4 level
Time Frame: 4 months
|
4 months
|
|
Serum high-sensitive C reactive protein (hs-CRP)
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rahimeh Akrami, PhD, Shiraz University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
- Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten 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. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 29, 2016
First Submitted That Met QC Criteria
February 1, 2016
First Posted (Estimate)
February 2, 2016
Study Record Updates
Last Update Posted (Estimate)
February 2, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRCT2015080110410N2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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