A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
NCT ID: NCT00904592
Last Updated: 2012-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
2008-09-30
2011-04-30
Brief Summary
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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
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* 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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Qi ming granula
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
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
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
Interventions
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Qi ming granula
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
75 Years
ALL
No
Sponsors
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Chengdu University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Junguo Duan
Role: PRINCIPAL_INVESTIGATOR
Chengdu University of TCM
Locations
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Chengdu University of TCM
Chengdu, Sichuan, China
Countries
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Related Links
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Other Identifiers
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2006BAI04A0401
Identifier Type: -
Identifier Source: org_study_id