Clinical trial NCT00904592: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
traditional chinese medicine
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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
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 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.

Primary outcomes:
measure: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
timeFrame: 12 months
Secondary outcomes:
measure: Symptoms scores of TCM
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Junguo Duan
role: PRINCIPAL_INVESTIGATOR
References: