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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Qi ming granula
Placebo Comparator
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, traditional chinese medicine

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qi ming granula

placebo comparator

Arm Description

Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education. Qi ming granula, Usage: 4.5g，po，tid.

Control group: Basic therapy ＆ placebo Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. placebo,Usage: 4.5g，po，tid

Outcomes

Primary Outcome Measures

incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

Secondary Outcome Measures

Symptoms scores of TCM

Full Information

First Posted
December 24, 2008
Last Updated
August 20, 2012
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00904592
Brief Title
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Official Title
A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy. 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. Study Type: Interventional Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study. Sample size: 480 subjects , divided into test and control groups equally. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Detailed Description
Primary outcome: proliferative diabetic retinopathy panretinal photocoagulation 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, traditional chinese medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qi ming granula
Arm Type
Experimental
Arm Description
Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education. Qi ming granula, Usage: 4.5g，po，tid.
Arm Title
placebo comparator
Arm Type
Placebo Comparator
Arm Description
Control group: Basic therapy ＆ placebo Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. placebo,Usage: 4.5g，po，tid
Intervention Type
Drug
Intervention Name(s)
Qi ming granula
Other Intervention Name(s)
QM
Intervention Description
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
PC
Intervention Description
Control group: Basic therapy ＆ placebo Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. placebo,Usage: 4.5g，po，tid
Primary Outcome Measure Information:
Title
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Symptoms scores of TCM
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junguo Duan
Organizational Affiliation
Chengdu University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19802544?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1
Description
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A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

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