NCT04030611

The Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic Retinopathy Diabetic retinopathy-a Pilot Study

Assessment the Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic retinopathy-a Pilot Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Diabetic retinopathy (DR) is the leading cause of impaired visual function and blindness in adults. The fundus photographs were examined to detect DR. The DR severity was graded non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scales. The pathogenesis of DR is complex and not fully understood, and platelet aggregation, microvascular damage, microvascular enlargement, leakage, hemorrhage, or obstruction, resulting in retinal hypoxia and retinal neovascularization. Traditional Chinese medicine (TCM) diagnostic tools are non-invasive and convenient. This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR. Furtherly we would evaluate the sensitivity and specificity of TCM diagnostic tools. This study is a prospective cross-sectional study. We enroll participants form the department of Chinese medicine, China Medical University Hospital. In total, 100 participants , composed of 50 of type 2 diabetes and 50 of diabetic retinopathy, whom previously had a retinal examination. We apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis in DR. This study aims to identify the clinical symptoms of DR with TCM diagnostic tools and investigate the pattern difference and treatment for DR. Furtherly, we could design a clinical trial with improving blood circulation to treat or prevent DR, and improve the health status and quality of life in patients with type 2 diabetes.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	tongue diagnosis system	This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-09-01
• Completion: 2019-10-10
• First posted: 2019-07-24
• Last updated: 2019-07-24

Locations

1 site across 1 country: Taiwan