NCT00904592

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

2.1 years

First QC Date

December 24, 2008

Last Update Submit

August 20, 2012

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathytraditional chinese medicine

Outcome Measures

Primary Outcomes (1)

  • incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

    12 months

Secondary Outcomes (1)

  • Symptoms scores of TCM

    12 weeks

Study Arms (2)

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.

Drug: Qi ming granula

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

Drug: Placebo Comparator

Interventions

Qi ming granulaDRUG

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

Also known as: QM
Qi ming granula
Placebo ComparatorDRUG

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

Also known as: PC
placebo comparator

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Junguo Duan

    Chengdu University of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2008

First Posted

May 19, 2009

Study Start

September 1, 2008

Primary Completion

October 1, 2010

Study Completion

April 1, 2011

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

CN(1)