Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 7:41 PM
Study NCT ID:
NCT00904592
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2008-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Sponsor:
Chengdu University of Traditional Chinese Medicine
Organization:
Study Overview
Official Title:
A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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).
* 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: