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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00904592
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Diabetic Retinopathy Drug: Qi ming granula Drug: Placebo Comparator

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Study Start Date : September 2008
Primary Completion Date : October 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: PC


Outcome Measures

Primary Outcome Measures :
  1. incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Symptoms scores of TCM [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00904592     History of Changes
Other Study ID Numbers: 2006BAI04A0401
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Chengdu University of Traditional Chinese Medicine:
diabetic retinopathy
traditional chinese medicine

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases