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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00904592
First received: December 24, 2008
Last updated: August 20, 2012
Last verified: August 2012
  Purpose
  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 Intervention
Diabetic Retinopathy
Drug: Qi ming granula
Drug: Placebo Comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Symptoms scores of TCM [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 480
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00904592     History of Changes
Other Study ID Numbers: 2006BAI04A0401
Study First Received: December 24, 2008
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014