A Study on Traditional Chinese Medicine (TCM) Comprehensi... | NCT00904592

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

NCT00904592

Sponsor

Chengdu University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Aug 21, 2012Estimated

Enrollment

480Actual

Phase

Not Applicable

Conditions

Diabetic Retinopathy

Interventions

Qi ming granula
Placebo Comparator

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Apr 2011Actual

First Submitted Date

Dec 24, 2008

First Submission Date that Met QC Criteria

May 18, 2009

First Posted Date

May 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Qi ming granula	Experimental	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.	Drug: Qi ming granula
placebo comparator	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	Drug: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Qi ming granula	Drug	Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event	Qi ming granula

Measure	Description	Time Frame
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation		12 months

Measure	Description	Time Frame
Symptoms scores of TCM		12 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases