Effect of Turmeric on Pruritus in Hemodialysis Patients | NCT01037595

Studies
Effect of Turmeric on Pruritus in Hemodialysis Patients

NCT01037595

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

May 14, 2013Estimated

Enrollment

60Actual

Phase

Early Phase 1

Conditions

End Stage Renal Failure

Interventions

turmeric
placebo
turmeric

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 22, 2009

First Posted Date

Dec 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2013

Last Update Posted Date

May 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maryam Pakfetrat, associated professor of shiraz Shiraz University of Medical Sciences, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

pruritus is a common in hemodialysis patients and many treatment recommended for it . as turmeric has anti-inflammatory , anti-cytokine and anti-oxidant effect it may effective in treatment of uremic pruritus. thus we compared turmeric with placebo in this study

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
turmeric	Experimental	turmeric 500 mg tid orally for 8 weeks	Drug: turmeric
plasebo	Placebo Comparator	placebo tid orally for 8 weeks	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
turmeric	Drug	turmeric 500 md tid orally for 8 weeks	turmeric
placebo

Measure	Description	Time Frame
improvement in pruritus		6 mo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Use other treatment for pruritus

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University Hemodialysis Center		Shiraz	Fars	098	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33283264	Derived	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D011537	Pruritus

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic