Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02671162

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).

Study Design

Study Type:

Interventional

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 :

Jul 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Severity of Pruritis as measured by a visual analogue scale (VAS) [3 months]
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.

Secondary Outcome Measures

Serum Interferon-gamma level [4 months]
Serum IL-4 level [4 months]
Serum high-sensitive C reactive protein (hs-CRP) [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

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