A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy
- Interventions
- Drug: Placebo Comparator
- Registration Number
- NCT00904592
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- 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 Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qi ming granula Qi ming granula Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood. 1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education. 2. Qi ming granula, Usage: 4.5g，po，tid. placebo comparator Placebo Comparator Control group: Basic therapy ＆ placebo 1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. 2. placebo,Usage: 4.5g，po，tid
- Primary Outcome Measures
Name Time Method incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation 12 months
- Secondary Outcome Measures
Name Time Method Symptoms scores of TCM 12 weeks
Trial Locations
- Locations (1)
Chengdu University of TCM
🇨🇳Chengdu, Sichuan, China