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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904592
• Other study ID #: 2006BAI04A0401
• Status: Completed
• Phase: N/A
• First received: December 24, 2008
• Last updated: August 20, 2012
• Start date: September 2008
• Est. completion date: April 2011

Study information

• Verified date: August 2012
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Qi ming granula
Qi ming granula Usage:4.5g,po,tid. duration:12 months/ arise Endpoint Event
• Placebo Comparator
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

Locations

Country	Name	City	State
China	Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation		12 months	Yes
Secondary	Symptoms scores of TCM		12 weeks	Yes

External Links

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