NCT01015937

Brief Summary

The purpose of this study is to investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

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

Study Start

First participant enrolled

March 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

November 16, 2009

Last Update Submit

November 17, 2009

Conditions

Diabetic NephropathyProteinuria

Keywords

diabetesnephropathyturmericserum IL8serum TGFbserumINFurinary IL8urine TGFb

Study Arms (2)

Turmeric

ACTIVE COMPARATOR

diabetic nephropathy patient more than 300 mg/proteinuria

Drug: Turmeric extract

ACE inhibitor + ATI blocker

ACTIVE COMPARATOR

diabetic nephropathy more than 300 mg/day proteinuria

Drug: Turmeric extractDrug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker

Interventions

Turmeric extractDRUG

turmeric 500 mg TID for 45 days

Also known as: turmeric
ACE inhibitor + ATI blockerTurmeric
Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blockerDRUG

maximum dosage as patient tolerated for 45 days

Also known as: enalapril, losartan
ACE inhibitor + ATI blocker

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic nephropathy
  • more than 300 mg proteinuria/day
  • age more than 18 years old

You may not qualify if:

  • DM type 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic

Shiraz, Fars, 098, Iran

Location

MeSH Terms

Conditions

Diabetic NephropathiesProteinuriaDiabetes MellitusKidney Diseases

Interventions

turmeric extractCurcuminDipeptidyl-Peptidases and Tripeptidyl-PeptidasesReceptor, Angiotensin, Type 1EnalaprilLosartan

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicExopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesReceptors, AngiotensinReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, PeptideDipeptidesOligopeptidesPeptidesBiphenyl CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • maryam pakfetrat, assistant professor

    Shiraz nephro-urology research center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

March 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

IR(1)