Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00904592
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
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).
Study:
NCT00904592
Study Brief:
Protocol Section:
NCT00904592