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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00904592 |
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Date of registration:
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24/12/2008 |
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Primary sponsor: |
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Public title:
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A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
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Scientific title:
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A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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480 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00904592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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China
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Contacts
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Name:
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Junguo Duan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chengdu University of TCM |
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Key inclusion & exclusion 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.
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Retinopathy
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Intervention(s)
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Drug: Placebo Comparator
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Drug: Qi ming granula
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Primary Outcome(s)
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incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
[Time Frame: 12 months]
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Secondary Outcome(s)
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Symptoms scores of TCM
[Time Frame: 12 weeks]
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Secondary ID(s)
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2006BAI04A0401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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