NCT02671162

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

January 29, 2016

Last Update Submit

February 1, 2016

Conditions

End-Stage Renal DiseasePruritus

Keywords

PruritusEnd-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Serum Interferon-gamma level

    4 months

  • Serum IL-4 level

    4 months

  • Serum high-sensitive C reactive protein (hs-CRP)

    4 months

Study Arms (2)

Wheat

PLACEBO COMPARATOR

Placebo capsule/ 2 capsule 3 times per day

Drug: Wheat

Fumaria

ACTIVE COMPARATOR

Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.

Drug: Fumaria

Interventions

WheatDRUG

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

Wheat
FumariaDRUG

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

Fumaria

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Liver disease
  • Respiratory disease
  • Dermatological disease
  • Hemoglobin less than 10
  • Cholestasis
  • Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21372257BACKGROUND

  • 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.

    PMID: 16249205BACKGROUND

  • 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.

    PMID: 33283264DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicPruritus

Interventions

FlourFumariae herba

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jamshid Roozbeh, MD

    Shiraz University of Medical Sciences

    STUDY CHAIR

  • Pouya Faridi, PhD

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

  • Rahimeh Akrami, PhD

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 2, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share