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

August 20, 2012 updated by: Chengdu University of Traditional Chinese Medicine

A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qi ming granula

Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood.

  1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education.
  2. Qi ming granula, Usage: 4.5g，po，tid.
Drug: Qi ming granula
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
Other Names:
  • QM
Placebo Comparator: 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
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
Other Names:
  • PC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms scores of TCM
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Junguo Duan, Chengdu University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 20, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI04A0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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