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Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

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ClinicalTrials.gov Identifier: NCT02671162
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Rahimeh Akrami, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Pruritus Drug: Wheat Drug: Fumaria Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Wheat
Placebo capsule/ 2 capsule 3 times per day
Drug: Wheat
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.
Drug: Fumaria
3 times a day each time 2 capsules before eating meal for 8 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671162


Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Study Chair: Jamshid Roozbeh, MD Shiraz University of Medical Sciences
Study Director: Pouya Faridi, PhD Shiraz University of Medical Sciences
Principal Investigator: Rahimeh Akrami, PhD Shiraz University of Medical Sciences
Additional Information:
Publications:
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Responsible Party: Rahimeh Akrami, Dr., Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02671162    
Other Study ID Numbers: IRCT2015080110410N2
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Rahimeh Akrami, Shiraz University of Medical Sciences:
Pruritus
End-Stage Renal Disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Pruritus
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Skin Diseases
Skin Manifestations