Diabetic RetinopathyNCT00904592
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
A study testing Qi ming granula in people with Diabetic Retinopathy, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Qi ming granula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
- 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
Read the 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).
- Conditions
- Diabetic Retinopathy
- Being tested
- Qi ming granula, Placebo Comparator
- Keywords
- diabetic retinopathy, traditional chinese medicine
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi ming granulaDrug
Also called QM
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
Placebo ComparatorDrug
Also called PC
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Measured: 12 months
Secondary outcomes (1)
Symptoms scores of TCM
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junguo Duan, Principal investigator, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904592
- Sponsor's protocol ID
- 2006BAI04A0401
- Status last verified
- Aug 2012
- First submitted
- 24 Dec 2008
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00904592
- Acronym / sponsor ID
- 2006BAI04A0401
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, traditional chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qi ming granula | Experimental | Drug: Qi ming granulaStudy 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. |
| placebo comparator | Placebo comparator | Drug: Placebo ComparatorControl 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qi ming granulaAlso: QMQi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event | Drug | Qi ming granula |
| Placebo ComparatorAlso: PCControl 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 |
Primary outcome
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Time frame: 12 months
1 secondary outcome
Symptoms scores of TCM
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junguo Duan principal investigator
Chengdu University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qi ming granula in people with Diabetic Retinopathy, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.