A Phase 4 interventional study of Calcium dobesilate (Doxium) and Placebo drug in Diabetic Retinopathy, sponsored by Tabriz University. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-06-27.
Sponsored by Tabriz University · Phase 4, Interventional, and Prevention
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Tabriz University is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Placebo tablets will be administered to the patients in Placebo arms daily for three months.
Drug: Placebo drug
Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.
Drug: Calcium dobesilate (Doxium)
500 mg, Tablet, Daily, 3 months
Similar to the that of the Experimental arm, Daily, Three months
high sensitivity CRP and Endothelin-1 serum levels
Time frame: 3 month
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Tabriz University