NCT01037595

Brief Summary

The purpose of this study is to see whether turmeric can be effective in treatment of pruritus in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2010

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

1 month

First QC Date

December 22, 2009

Last Update Submit

May 12, 2013

Conditions

End Stage Renal Failure

Keywords

hemodialysisturmericpruritus

Outcome Measures

Primary Outcomes (1)

  • improvement in pruritus

    6 mo

Study Arms (2)

turmeric

EXPERIMENTAL

turmeric 500 mg tid orally for 8 weeks

Drug: turmeric

plasebo

PLACEBO COMPARATOR

placebo tid orally for 8 weeks

Drug: placebo

Interventions

turmericDRUG

turmeric 500 md tid orally for 8 weeks

turmeric
placeboDRUG

placebo 3 time orally for 8 weeks

plasebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis for more than 3 months
  • More than 18 years old
  • Pruritus

You may not qualify if:

  • Use other treatment for pruritus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University Hemodialysis Center

Shiraz, Fars, 098, Iran

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Renal Insufficiency, ChronicPruritus

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Renal 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)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor of shiraz Shiraz University of Medical Sciences

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

IR(1)