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

Tracking Information
First Received Date ^ICMJE	May 21, 2010
Last Updated Date	June 24, 2011
Start Date ^ICMJE	November 2009
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 24, 2011)	high sensitivity CRP and Endothelin-1 serum levels [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01382498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Diabetic Retinopathy
Intervention ^ICMJE	Drug: Calcium dobesilate (Doxium) 500 mg, Tablet, Daily, 3 months Drug: Placebo drug Similar to the that of the Experimental arm, Daily, Three months
Study Arm (s)	Placebo Comparator: Placebo Placebo tablets will be administered to the patients in Placebo arms daily for three months. Intervention: Drug: Placebo drug Experimental: Calcium dobesilate Calcium dobesilate as 500 mg tablets will be administered once to the patients daily. Intervention: Drug: Calcium dobesilate (Doxium)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	90
Completion Date	Not Provided
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01382498
Other Study ID Numbers ^ICMJE	88-8
Has Data Monitoring Committee	Not Provided
Responsible Party	Tabriz Medical University Biotechnology research center, Tabriz University of Medical Sciences
Study Sponsor ^ICMJE	Tabriz University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tabriz University
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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