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NCT01382498 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01382498
Other study ID # 88-8
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received May 21, 2010
Last updated June 24, 2011
Start date November 2009

Study information
Verified date April 2011
Source Tabriz University
Contact n/a
Is FDA regulated No
Health authority Iran:Tabriz Medical University Biotechnology research center
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Calcium dobesilate (Doxium)
500 mg, Tablet, Daily, 3 months
• Placebo drug
Similar to the that of the Experimental arm, Daily, Three months

Locations
Country Name City State
Iran, Islamic Republic of Tabriz University of Medical Sciences Tabriz Eastern Azerbayjan

Sponsors (1)
Lead Sponsor Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary high sensitivity CRP and Endothelin-1 serum levels 3 month No
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