Status:
COMPLETED
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
35-75 years
Phase:
NA
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...
Detailed Description
1. Primary outcome: * proliferative diabetic retinopathy * panretinal photocoagulation 2. Secondary outcome: * Vision, Funduscopy, Fundus photograph * Fundus fluorescein angiography *...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00904592
Start Date
September 1 2008
End Date
April 1 2011
Last Update
August 21 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chengdu University of TCM
Chengdu, Sichuan, China, 610075