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

NCT01003236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-06-25

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

placebo

140 mg placebo tablets, 3 times per day for 3 months

DRUG

Milk Thistle extract

1 tablet equal to 140mg silymarin administered 3 times a day for 3 months

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ghazal Vessal, PharmD, PhD · Shiraz University of Medical Sciences, Faculty of Pharmacy

  • Mohammad Mehdi Sagheb, MD · Shiraz University of Medical Sciences

  • Jamshid Roozbeh, MD · Shiraz University of Medical Sciences, Nephrology Urology Research Center

  • Mohammad Kazem Fallahzadeh Abarghouei, M.D. · Shiraz University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • Iran

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003236 on ClinicalTrials.gov