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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Criteria

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.