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:

  1. Diabetic Retinopathy

    Brief Summary:

    1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy.
    2. 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.
    3. Study Type: Interventional
    4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study.
    5. Sample size: 480 subjects , divided into test and control groups equally.
    6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

    Detailed Summary:

    1. Primary outcome:

      • proliferative diabetic retinopathy
      • panretinal photocoagulation

    2. 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