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A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

NCT00904592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2012-08-21

No results posted yet for this study

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

Conditions

Interventions

DRUG

Qi ming granula

Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event

DRUG

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

Sponsors & Collaborators

  • Chengdu University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Junguo Duan · Chengdu University of TCM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-10-31
Completion
2011-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904592 on ClinicalTrials.gov