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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT01382498
First received: May 21, 2010
Last updated: June 24, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
 Drug: Calcium dobesilate (Doxium)
Drug: Placebo drug
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • high sensitivity CRP and Endothelin-1 serum levels [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablets will be administered to the patients in Placebo arms daily for three months.
 Drug: Placebo drug
Similar to the that of the Experimental arm, Daily, Three months
Experimental: Calcium dobesilate
Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.
 Drug: Calcium dobesilate (Doxium)
500 mg, Tablet, Daily, 3 months

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382498

Locations
Iran, Islamic Republic of
Tabriz University of Medical Sciences
Tabriz, Eastern Azerbayjan, Iran, Islamic Republic of, 5137874976
Sponsors and Collaborators
Tabriz University
  More Information

No publications provided

Responsible Party: Tabriz Medical University Biotechnology research center, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01382498     History of Changes
Other Study ID Numbers: 88-8
Study First Received: May 21, 2010
Last Updated: June 24, 2011
Health Authority: Iran:Tabriz Medical University Biotechnology research center

Keywords provided by Tabriz University:
Endothelin-1 high sensitivity CRP

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Calcium, Dietary
Calcium Dobesilate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013