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Effect of Turmeric on Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy, Proteinuria

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Turmeric extract
Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker
Sponsored by
Shaheed Faghihi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring diabetes, nephropathy, turmeric, serum IL8, serum TGFb, serumINF, urinary IL8, urine TGFb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • DM type 1

Sites / Locations

  • Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Turmeric

ACE inhibitor + ATI blocker

Arm Description

diabetic nephropathy patient more than 300 mg/proteinuria

diabetic nephropathy more than 300 mg/day proteinuria

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 16, 2009
Last Updated
November 17, 2009
Sponsor
Shaheed Faghihi Hospital
Collaborators
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01015937
Brief Title
Effect of Turmeric on Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shaheed Faghihi Hospital
Collaborators
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Proteinuria
Keywords
diabetes, nephropathy, turmeric, serum IL8, serum TGFb, serumINF, urinary IL8, urine TGFb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turmeric
Arm Type
Active Comparator
Arm Description
diabetic nephropathy patient more than 300 mg/proteinuria
Arm Title
ACE inhibitor + ATI blocker
Arm Type
Active Comparator
Arm Description
diabetic nephropathy more than 300 mg/day proteinuria
Intervention Type
Drug
Intervention Name(s)
Turmeric extract
Other Intervention Name(s)
turmeric
Intervention Description
turmeric 500 mg TID for 45 days
Intervention Type
Drug
Intervention Name(s)
Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker
Other Intervention Name(s)
enalapril, losartan
Intervention Description
maximum dosage as patient tolerated for 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diabetic nephropathy more than 300 mg proteinuria/day age more than 18 years old Exclusion Criteria: DM type 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maryam pakfetrat, assistant professor
Organizational Affiliation
Shiraz nephro-urology research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic
City
Shiraz
State/Province
Fars
ZIP/Postal Code
098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Turmeric on Diabetic Nephropathy

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