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

NCT01382498 | Unknown Phase 4

• 1 other identifier: 88-8
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Endothelin-1 high sensitivity CRP

Outcome Measures

Primary Outcomes (1)

• high sensitivity CRP and Endothelin-1 serum levels

  3 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo drug

Calcium dobesilate

EXPERIMENTAL

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

Drug: Calcium dobesilate (Doxium)

Interventions

Calcium dobesilate (Doxium) DRUG

500 mg, Tablet, Daily, 3 months

Calcium dobesilate

Placebo drug DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to doxium
• incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Sponsors & Collaborators

• Tabriz University: lead

Study Sites (1)

Tabriz University of Medical Sciences

Tabriz, Eastern Azerbayjan, 5137874976, Iran

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: June 27, 2011
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-04

Locations

IR (1)