A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

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

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).

Inclusion Criteria:

• Diagnosed with diabetes mellitus.
• Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy
• and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125).
• Diagnosed with the syndrome and signs of TCM.
• HbA1C≤8.0%.
• Ages ranged from 35 to 75 years.
• Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion Criteria:

• Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.
• The patients who have been received the therapy of Retina laser photocoagulation.
• The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.
• DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.
• Combined with other severe Diabetic complication.
• Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness
• Pregnant or breast feeding.
• combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis.
• Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
• Participated in other clinical trial within 3 month.