COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382498
Recruitment Status : Unknown
Verified April 2011 by Tabriz University.
Recruitment status was:  Enrolling by invitation
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Information provided by:
Tabriz University

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Calcium dobesilate (Doxium) Drug: Placebo drug Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2009
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. high sensitivity CRP and Endothelin-1 serum levels [ Time Frame: 3 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382498

Layout table for location information
Iran, Islamic Republic of
Tabriz University of Medical Sciences
Tabriz, Eastern Azerbayjan, Iran, Islamic Republic of, 5137874976
Sponsors and Collaborators
Tabriz University

Layout table for additonal information
Responsible Party: Tabriz Medical University Biotechnology research center, Tabriz University of Medical Sciences Identifier: NCT01382498    
Other Study ID Numbers: 88-8
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: April 2011
Keywords provided by Tabriz University:
Endothelin-1 high sensitivity CRP
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Calcium, Dietary
Calcium Dobesilate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents