Clinical Trial: A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Study Status: Completed
Recruit Status: Completed
Study Type:
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Diabetic Retinopathy
Brief Summary:
- Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy.
- Objectives of study: To evaluate the Intervention effect of integrate control protocol on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then produce a high performance, optimize, convenient, applicable and demonstrated protocol of integrate control with Intervention of TCM and west medicine.
- Study Type: Interventional
- Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study.
- Sample size: 480 subjects , divided into test and control groups equally.
- Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Detailed Summary:
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Primary outcome:
- proliferative diabetic retinopathy
- panretinal photocoagulation
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Secondary outcome:
- Vision, Funduscopy, Fundus photograph
- Fundus fluorescein angiography
- Visual Electrophysiology:FERG、OPs、PVEP.
- Optical coherence tomography.
- Symptoms scores of TCM.
- The M0S short-form-36 heaIth survey(SF-36).
- Visual Function Questionnaire-25(VFQ-25).
Sponsor: Chengdu University of Traditional Chinese Medicine
Current Primary Outcome: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Symptoms scores of TCM [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Chengdu University of Traditional Chinese Medicine
Dates:
Date Received: December 24, 2008
Date Started: September 2008
Date Completion:
Last Updated: August 20, 2012
Last Verified: August 2012