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Clinical Trials/NCT00904592
NCT00904592CompletedNot Applicable

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

Chengdu University of Traditional Chinese Medicine1 site in 1 country480 target enrollmentStarted: September 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
480
Locations
1
Primary Endpoint
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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
  1. 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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
35 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Qi ming granula

Experimental

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.

Intervention: Qi ming granula (Drug)

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

Intervention: Placebo Comparator (Drug)

Outcomes

Primary Outcomes

incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

Time Frame: 12 months

Secondary Outcomes

  • Symptoms scores of TCM(12 weeks)

Investigators

Sponsor
Chengdu University of Traditional Chinese Medicine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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