A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
This study has been completed.
Sponsor:
Chengdu University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00904592
First received: December 24, 2008
Last updated: August 20, 2012
Last verified: August 2012
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Purpose
- 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
| Condition | Intervention |
|---|---|
|
Diabetic Retinopathy |
Drug: Qi ming granula Drug: Placebo Comparator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy |
Resource links provided by NLM:
Further study details as provided by Chengdu University of Traditional Chinese Medicine:
Primary Outcome Measures:
- incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Symptoms scores of TCM [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 480 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Qi ming granula
Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood.
|
Drug: Qi ming granula
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
Other Name: QM
|
|
Placebo Comparator: placebo comparator
Control group: Basic therapy ＆ placebo
|
Drug: Placebo Comparator
Control group: Basic therapy ＆ placebo
Other Name: PC
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904592
Locations
| China, Sichuan | |
| Chengdu University of TCM | |
| Chengdu, Sichuan, China, 610075 | |
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
| Principal Investigator: | Junguo Duan | Chengdu University of TCM |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chengdu University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT00904592 History of Changes |
| Other Study ID Numbers: | 2006BAI04A0401 |
| Study First Received: | December 24, 2008 |
| Last Updated: | August 20, 2012 |
| Health Authority: | United States: Food and Drug Administration China: Food and Drug Administration |
Keywords provided by Chengdu University of Traditional Chinese Medicine:
|
diabetic retinopathy traditional chinese medicine |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013