Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Conditions
Diabetic Nephropathy
Intervention
placebo, Milk Thistle extract
Location
Motahari Clinic
Shiraz
Fars
Iran, Islamic Republic of
71345
Status
Not yet recruiting
Source
Shiraz University of Medical Sciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01003236
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Milk Thistle
The plant Silybum marianum in the family ASTERACEAE containing the bioflavonoid complex SILYMARIN. For centuries this has been used traditionally to treat liver disease. Silybum marianum (L.) Gaertn. = Carduus marianus L.
Milk Hypersensitivity
Allergic reaction to milk (usually cow's milk) or milk products. MILK HYPERSENSITIVITY should be differentiated from LACTOSE INTOLERANCE, an intolerance to milk as a result of congenital deficiency of lactase.
Silymarin
A mixture of flavonoids extracted from seeds of the MILK THISTLE, Silybum marianum. It consists primarily of silybin and its isomers, silicristin and silidianin. Silymarin displays antioxidant and membrane stabilizing activity. It protects various tissues and organs against chemical injury, and shows potential as an antihepatoxic agent.
Semecarpus
A plant genus of the family ANACARDIACEAE that is the source of anacarcin forte. The nut milk extract is cytotoxic.
Thyroid Extract, Desiccated
A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.
Clinical Trials
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
The study is designed to test if the combination of two potent antioxidant nutritional supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting the shed...
There is some information available that indicates that Milk Thistle is an effective treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine that look...
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors,...
RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating liver disorders caused by cancer therapy. PURPOSE: Randomized phase II trial to study the effectiv...
Effect of Turmeric on Diabetic Nephropathy
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.
PubMed Articles
The botanical product silymarin, an extract of milk thistle, is commonly used by patients to treat chronic liver disease, despite scant and conflicting evidence of its efficacy.
Inhibitory effects of commonly used herbal extracts on UGT1A1 enzyme activity.
Commonly used herbal supplements were screened for their potential to inhibit UGT1A1 activity using human liver microsomes. Extracts screened included ginseng, echinacea, black cohosh, milk thistle, g...
Mechanisms of Diabetic Nephropathy - Old Buddies and Newcomers Part 2.
The clinical translation of established pathomechanisms of diabetic nephropathy improved the outcome in patients with diabetic nephropathy. However, they fail to halt or even reverse diabetic nephropa...
Diabetic nephropathy: lessons from the mouse.
A fundamental problem in the identification of new molecular targets for therapeutic intervention in diabetic nephropathy has been the lack of an experimental mouse model that faithfully recapitulates...
Diabetic nephropathy in 2010: Alleviating the burden of diabetic nephropathy.
