Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy

Tabriz University

Status and phase: Unknown; Phase 4

Conditions: Diabetic Retinopathy

Treatments: Drug: Placebo drug; Drug: Calcium dobesilate (Doxium)

Study type: Interventional

Funder types: Other

Identifiers

NCT01382498

88-8

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BS 120-200 mg/dl
• Age 40-70
• Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
• type II diabetes
• no history of doxium consumption

Exclusion criteria

• Allergy to doxium
• incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets will be administered to the patients in Placebo arms daily for three months.

Treatment:

Drug: Placebo drug

Calcium dobesilate

Experimental group

Description:

Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.

Treatment:

Drug: Calcium dobesilate (Doxium)