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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01382498
Enrollment
90
Registered
2011-06-27
Start date
2009-11-30
Completion date
Unknown
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Endothelin-1 high sensitivity CRP

Brief 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.

Interventions

500 mg, Tablet, Daily, 3 months

DRUGPlacebo drug

Similar to the that of the Experimental arm, Daily, Three months

Sponsors

Tabriz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
high sensitivity CRP and Endothelin-1 serum levels3 month

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026