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

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

Detailed Description
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Primary outcome: proliferative diabetic retinopathy panretinal photocoagulation 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).

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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Qi ming granula
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qi ming granula<br>Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education. Qi ming granula, Usage: 4.5g，po，tid. | Drug: Qi ming granula<br>* Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event<br>* Other names: QM;|
| Placebo Comparator: placebo comparator<br>Control group: Basic therapy ＆ placebo Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. placebo,Usage: 4.5g，po，tid | Drug: Placebo Comparator<br>* Control group: Basic therapy ＆ placebo Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. placebo,Usage: 4.5g，po，tid<br>* Other names: PC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms scores of TCM |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, traditional chinese medicine