We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Tabriz University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382498
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
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.
Information provided by:
Tabriz University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Tabriz University:

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

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

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.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 21, 2010
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
Last Verified: April 2011

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

Additional relevant 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
Bone Density Conservation Agents
Physiological Effects of Drugs
Hemostatics
Coagulants