Diabetic NephropathyNCT01015937
Effect of Turmeric on Diabetic Nephropathy
A study testing Turmeric extract and Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker in people with Diabetic Nephropathy and Proteinuria, run by Shaheed Faghihi Hospital at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy, Proteinuria
- What is being tested?
- Turmeric extract and Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Mar 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic nephropathy
- more than 300 mg proteinuria/day
- age more than 18 years old
Who cannot join
- DM type 1
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Nephropathy, Proteinuria
- Being tested
- Turmeric extract, Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker
- Keywords
- diabetes, nephropathy, turmeric, serum IL8, serum TGFb, serumINF, urinary IL8, urine TGFb
- Medical subject headings
- Diabetic Nephropathies, Proteinuria, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmeric extractDrug
Also called turmeric
turmeric 500 mg TID for 45 days
Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blockerDrug
Also called enalapril, losartan
maximum dosage as patient tolerated for 45 days
| Study group | Role | What they receive |
|---|---|---|
| Turmeric | Active comparator | diabetic nephropathy patient
more than 300 mg/proteinuria Receives: Drug: Turmeric extract |
| ACE inhibitor + ATI blocker | Active comparator | diabetic nephropathy
more than 300 mg/day proteinuria Receives: Drug: Turmeric extract; Drug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Faghihi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Investigators
- maryam pakfetrat, assistant professor, Principal investigator, Shiraz nephro-urology research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015937
- Sponsor's protocol ID
- 3997
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Turmeric on Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01015937
- Acronym / sponsor ID
- 3997
- Conditions
- Diabetic Nephropathy, Proteinuria
- Keywords
- diabetes, nephropathy, turmeric, serum IL8, serum TGFb, serumINF, urinary IL8, urine TGFb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shaheed Faghihi HospitalUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turmeric | Active comparator | Drug: Turmeric extractdiabetic nephropathy patient more than 300 mg/proteinuria |
| ACE inhibitor + ATI blocker | Active comparator | Drug: Turmeric extract, Drug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blockerdiabetic nephropathy more than 300 mg/day proteinuria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetic nephropathy
- more than 300 mg proteinuria/day
- age more than 18 years old
Key exclusion criteria (1 listed)
- DM type 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turmeric extractAlso: turmericturmeric 500 mg TID for 45 days | Drug | ACE inhibitor + ATI blocker, Turmeric |
| Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blockerAlso: enalapril, losartanmaximum dosage as patient tolerated for 45 days | Drug | ACE inhibitor + ATI blocker |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maryam pakfetrat, assistant professor principal investigator
Shiraz nephro-urology research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmeric extract and Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker in people with Diabetic Nephropathy and Proteinuria, run by Shaheed Faghihi Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2009.