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
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
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
NCT ID
NCT01015937
First Posted
November 16, 2009
Last Updated
November 17, 2009
Sponsor
Shaheed Faghihi Hospital
Collaborators
Shiraz University of Medical Sciences
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
Learn more about this trial
Effect of Turmeric on Diabetic Nephropathy
We'll reach out to this number within 24 hrs