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Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
Milk Thistle extract
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic nephropathy, Type II Diabetes, Milk Thistle extract, Silymarin

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type II diabetes
  • Overt proteinuria defined by urinary albumin excretion > 300 mg/24 hr in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months.
  • Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a thiazolidinedione is used, stable dose for at least 6 months)
  • Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins
  • Presence of diabetic retinopathy
  • Signing informed consent

Exclusion Criteria:

  • Type I diabetes
  • Advanced chronic kidney disease defined by estimated GFR < 30 ml/min/1.73 m2
  • Severely uncontrolled diabetes defined by HbA1C > 10%
  • Uncontrolled hypertension defined by SBP >160 mmHg or DBP >100 mmHg despite antihypertensive therapy
  • Secondary forms of hypertension with defined etiology other than diabetes mellitus
  • Other renal diseases
  • History of solid organ transplantation
  • Chronic Heart Failure with NYHA class III or IV
  • Active infection
  • Pregnancy

  • Use of one of the following medications within 2 months prior to enrollment in the study:

    • Non-steroidal anti-inflammatory agents
    • Antioxidants supplements including: vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxyfilline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts
  • Active malignancy
  • Hepatitis virus or Human Immunodeficiency virus infections
  • History of drug or alcohol dependency
  • Cigarette smoking
  • Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol

Sites / Locations

  • Motahari Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

Milk Thistle extract

Arm Description

1 tablet 3 times daily

1 tablet of the extract (equivalent to 140 mg silymarin) 3 times per day

Outcomes

Primary Outcome Measures

Change from baseline in urinary albumin-creatinine ratio

Secondary Outcome Measures

Change from baseline in urinary TNF-α
Change from baseline in urinary TGF-β
Change from baseline in fasting plasma glucose
Change from baseline in blood lipid profile
Change from baseline in hemoglobin A1C
Change from baseline in urinary MDA
Change from baseline in serum TNF-α
Change from baseline in serum TGF-β
Change from baseline in serum MDA
Change from baseline in estimated GFR
Change from baseline in serum creatinine

Full Information

First Posted
October 27, 2009
Last Updated
June 21, 2012
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01003236
Brief Title
Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy
Official Title
Evaluating the Preventive Effect of Milk Thistle Extract (Silymarin) on Progression of Diabetic Nephropathy, a Randomized, Double-blind, Placebo-controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is considerable evidence that increased blood glucose results in the generation of reactive oxygen species, ultimately leading to increased oxidative stress in a variety of tissues. This may lead to the activation of stress-sensitive intracellular signaling pathways, causing cellular damage and late complications of diabetes including renal injury. Although the investigators understanding of how hyperglycemia-induced oxidative stress ultimately leads to tissue damage has advanced considerably in recent years, effective therapeutic strategies to prevent or delay the development of this damage remain limited. The flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological active component silibinin are free radical scavengers and potent membrane stabilizers by preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids minimize oxidative stress, and inflammation which represent important factors in the development of diabetic nephropathy. In this study the investigators plan to evaluate the renoprotective effect of milk thistle extract on type II diabetic patients with kidney disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic nephropathy, Type II Diabetes, Milk Thistle extract, Silymarin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet 3 times daily
Arm Title
Milk Thistle extract
Arm Type
Experimental
Arm Description
1 tablet of the extract (equivalent to 140 mg silymarin) 3 times per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
140 mg placebo tablets, 3 times per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Milk Thistle extract
Other Intervention Name(s)
Livergol made by Goldaru Pharmaceutical Company (Iran)
Intervention Description
1 tablet equal to 140mg silymarin administered 3 times a day for 3 months
Primary Outcome Measure Information:
Title
Change from baseline in urinary albumin-creatinine ratio
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Change from baseline in urinary TNF-α
Time Frame
3 month
Title
Change from baseline in urinary TGF-β
Time Frame
3 month
Title
Change from baseline in fasting plasma glucose
Time Frame
3 month
Title
Change from baseline in blood lipid profile
Time Frame
3 month
Title
Change from baseline in hemoglobin A1C
Time Frame
3 month
Title
Change from baseline in urinary MDA
Time Frame
3 month
Title
Change from baseline in serum TNF-α
Time Frame
3 month
Title
Change from baseline in serum TGF-β
Time Frame
3 month
Title
Change from baseline in serum MDA
Time Frame
3 month
Title
Change from baseline in estimated GFR
Time Frame
3 month
Title
Change from baseline in serum creatinine
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type II diabetes Overt proteinuria defined by urinary albumin excretion > 300 mg/24 hr in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months. Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a thiazolidinedione is used, stable dose for at least 6 months) Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins Presence of diabetic retinopathy Signing informed consent Exclusion Criteria: Type I diabetes Advanced chronic kidney disease defined by estimated GFR < 30 ml/min/1.73 m2 Severely uncontrolled diabetes defined by HbA1C > 10% Uncontrolled hypertension defined by SBP >160 mmHg or DBP >100 mmHg despite antihypertensive therapy Secondary forms of hypertension with defined etiology other than diabetes mellitus Other renal diseases History of solid organ transplantation Chronic Heart Failure with NYHA class III or IV Active infection Pregnancy Use of one of the following medications within 2 months prior to enrollment in the study: Non-steroidal anti-inflammatory agents Antioxidants supplements including: vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxyfilline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts Active malignancy Hepatitis virus or Human Immunodeficiency virus infections History of drug or alcohol dependency Cigarette smoking Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazal Vessal, PharmD, PhD
Organizational Affiliation
Shiraz University of Medical Sciences, Faculty of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Mehdi Sagheb, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, MD
Organizational Affiliation
Shiraz University of Medical Sciences, Nephrology Urology Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Kazem Fallahzadeh Abarghouei, M.D.
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motahari Clinic
City
Shiraz
State/Province
Fars
ZIP/Postal Code
71345
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22770926
Citation
Fallahzadeh MK, Dormanesh B, Sagheb MM, Roozbeh J, Vessal G, Pakfetrat M, Daneshbod Y, Kamali-Sarvestani E, Lankarani KB. Effect of addition of silymarin to renin-angiotensin system inhibitors on proteinuria in type 2 diabetic patients with overt nephropathy: a randomized, double-blind, placebo-controlled trial. Am J Kidney Dis. 2012 Dec;60(6):896-903. doi: 10.1053/j.ajkd.2012.06.005. Epub 2012 Jul 7.
Results Reference
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Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy

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