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

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Drug: Placebo Comparator; Drug: Qi ming granula

Study type: Interventional

Funder types: Other

Identifiers

NCT00904592

2006BAI04A0401

Details and patient eligibility

About

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

Full 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).

Enrollment: 480 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

480 participants in 2 patient groups, including a placebo group

Qi ming granula

Experimental group

Description:

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.

Treatment:

Drug: Qi ming granula

placebo comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Comparator