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

NCT ID: NCT01382498

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablets will be administered to the patients in Placebo arms daily for three months.

Group Type PLACEBO_COMPARATOR

Placebo drug

Intervention Type DRUG

Similar to the that of the Experimental arm, Daily, Three months

Calcium dobesilate

Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.

Group Type EXPERIMENTAL

Calcium dobesilate (Doxium)

Intervention Type DRUG

500 mg, Tablet, Daily, 3 months

Interventions

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Calcium dobesilate (Doxium)

500 mg, Tablet, Daily, 3 months

Intervention Type DRUG

Placebo drug

Similar to the that of the Experimental arm, Daily, Three months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University

OTHER

Sponsor Role lead

Responsible Party

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Tabriz University of Medical Sciences

Locations

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Tabriz University of Medical Sciences

Tabriz, Eastern Azerbayjan, Iran

Site Status

Countries

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Iran

Other Identifiers

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88-8

Identifier Type: -

Identifier Source: org_study_id

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