Back to resultsEffect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Calcium dobesilate (Doxium)
Placebo drug
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Retinopathy focused on measuring Endothelin-1 high sensitivity CRP
Eligibility 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
Sites / Locations
- Tabriz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Calcium dobesilate
Arm Description
Placebo tablets will be administered to the patients in Placebo arms daily for three months.
Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.
Outcomes
Primary Outcome Measures
high sensitivity CRP and Endothelin-1 serum levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382498
Brief Title
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Endothelin-1 high sensitivity CRP
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets will be administered to the patients in Placebo arms daily for three months.
Arm Title
Calcium dobesilate
Arm Type
Experimental
Arm Description
Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.
Intervention Type
Drug
Intervention Name(s)
Calcium dobesilate (Doxium)
Intervention Description
500 mg, Tablet, Daily, 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo drug
Intervention Description
Similar to the that of the Experimental arm, Daily, Three months
Primary Outcome Measure Information:
Title
high sensitivity CRP and Endothelin-1 serum levels
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tabriz University of Medical Sciences
City
Tabriz
State/Province
Eastern Azerbayjan
ZIP/Postal Code
5137874976
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
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