Effect of Turmeric on Diabetic Nephropathy | NCT01015937

Studies
Effect of Turmeric on Diabetic Nephropathy

NCT01015937

Sponsor

Shaheed Faghihi Hospital

Status

Completed

Last Update Posted

Nov 18, 2009Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Diabetic Nephropathy
Proteinuria

Interventions

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

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

Nov 2009

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

Mar 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 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

Nov 17, 2009

Last Update Posted Date

Nov 18, 2009Estimated

Name	Class
Shiraz University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

Detailed Description

Diabetic nephropathy is leading cause of ESRF that many therapy recommended for it. In this study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic nephropathy patients and divided them into 2 groups. One group received turmeric + ACE inhibitor + Angiotensin II receptor blocker (ARB) and the second group received only ACE inhibitor + ARB.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 extract Drug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Turmeric extract	Drug	turmeric 500 mg TID for 45 days	ACE inhibitor + ATI blocker Turmeric

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

DM type 1

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
maryam pakfetrat, assistant professor	Shiraz nephro-urology research center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic		Shiraz	Fars	098	Iran

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies
D011507	Proteinuria
D003920	Diabetes Mellitus
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C012596	turmeric extract
D003474	Curcumin
D004152	Dipeptidyl-Peptidases and Tripeptidyl-Peptidases
D044140	Receptor, Angiotensin, Type 1
D004656	Enalapril
D019808	Losartan

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided