Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy
This study has been completed.
Sponsor:
Chengdu University of Traditional Chinese Medicine
Collaborator:
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01373476
First received: April 26, 2011
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
Objectives of study: To preliminarily evaluate the efficacy and safety of Qideng Mingmu Capsule in the treatment of patients with diabetic retinopathy (deficiency of Qi-Yin syndrome, blood stasis syndrome), to discuss the appropriate dose and period of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy Diabetic Eye Problems Retinal Disorders |
Drug: Qideng Mingmu capsule Drug: Placebo Comparator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicentre,Randomized,Double-blind, Multiple-dose, Placebo-controlled, Parallel-Group Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy With Blood Stasis Syndrome and Deficiency of Qi-Yin Syndrome |
Resource links provided by NLM:
Further study details as provided by Chengdu University of Traditional Chinese Medicine:
Primary Outcome Measures:
- Ocular fundus [ Time Frame: Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fundus fluorescein angiography (FFA) [ Time Frame: at baseline phase and 24 weeks after randomization ] [ Designated as safety issue: No ]Fundus fluorescein angiography (FFA) is to be tested at baseline phase and 12, 24 weeks after randomization, which will provide details of retinal circulation time(retinal arterial stage, capillary transition stage and venous stage included),non-perfusion areas in capillary of the retina(location and range noted),and leakage from the retinal vessels(location and range noted).
- best-corrected ETDRS visual acuity [ Time Frame: at baseline phase and every four weeks after randomization. ] [ Designated as safety issue: No ]best-corrected ETDRS visual acuity will be captured at baseline phase and every four weeks after randomization.
- Traditional Chinese medical (TCM) syndrome scores [ Time Frame: at baseline phase and every four weeks after randomization. ] [ Designated as safety issue: No ]Traditional Chinese medical (TCM) syndrome scores will be collected at baseline phase and every four weeks after randomization.
- the observation of Ocular fundus [ Time Frame: at baseline phase and 12, 24 weeks after randomization ] [ Designated as safety issue: No ]Ocular fundus is to be examined by color fundus image at baseline phase and 12, 24 weeks after randomization, reflecting the abnormality of intraretinal microvasculature.
- Optic coherence tomography (OCT) [ Time Frame: at baseline phase and 12, 24 weeks after randomization ] [ Designated as safety issue: No ]Optic coherence tomography (OCT) is to be tested at baseline phase and 12, 24 weeks after randomization, indicating the degree of macular edema.
| Enrollment: | 240 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Qideng Mingmu capsule
High dosage group,Middle dosage group,Low dosage group.
|
Drug: Qideng Mingmu capsule
High dosage group (4 Qideng Mingmu capsules each time): 4#, po, tid,24 weeks; Middle dosage group (2 Qideng Mingmu capsules plus 2 placebos each time):4#, po, tid,24 weeks;Low dosage group (1 Qideng Mingmu capsule plus 2 placebos each time):3#, po, tid,24 weeks.
|
|
Placebo Comparator: Placebo
Placebo group
|
Drug: Placebo Comparator
Placebo group (4 placebos each time):4#, po, tid,24 weeks.
Other Name: Placebo Comparator
|
Detailed Description:
The efficacy of Qideng Mingmu capsule is to nourish qi-yin and promote blood circulation. It is used in patients with diabetic retinopathy who are differentiated as deficiency of Qi-Yin syndrome and blood stasis syndrome in traditional Chinese medicine(TCM).The manifestation of diabetic retinopathy(DR) mainly includes dim and dry eyes,shortness of breathe, fundus hemorrhage,etc.The experimental research indicated that the Qideng Mingmu capsule could improve the GK rats' quality of life,through reducing vascular endothelial growth factor(VEGF) level in vitreous of GK rats and inhibiting the expression of protein kinase C(PKC),therefore is capillary protective agent against retinal impairment in GK rat.The toxicology test has proved that the clinical dosage of Qideng Mingmu capsule is safe.Both acute and long-term toxicity tests has showed no toxicity.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with non-proliferative diabetic retinopathy(NPDR)，differentiated as deficiency of Qi-Yin syndrome or blood stasis syndrome in traditional Chinese medicine(TCM).
- best-corrected ETDRS visual acuity in study eye≥15 letters,or about 0.16(20/125) by the decimal point method.
- Age between 30 and 70 years old.
- Able and willing to give informed consent
- Keep the level of blood sugar steady during the last three months before randomization, meanwhile the glucose lowering therapy could be predicted without any change during this study.
- Eligible patients are with moderate and severe diabetic retinopathy primarily, mild of whom are controlled within 15%.
- All procedures from participance in the study voluntarily, signature on the Informed Consent Form (ICF) and acceptance of treatment are according to GCP guidelines.
Exclusion Criteria:
- Patients with ineffective blood sugar control (HbAlc>9%) or without usage of fundamental antidiabetic drugs such as biguanides, sulfonylureas (SUs), insulin and thiazolidinediones (TZDs).
- Patients who have had intraocular surgery like retina photocoagulation within 6 month; or are appropriate for laser photocoagulation currently, on the condition that more than two quadrants have extensive non-perfusion areas.
- Patients with other ophthalmological combined diseases like glaucoma, cataract that have effected the check of eyeground deeply, non-diabetic retinopathy, uveitis, retinal detachment, diseases of optic nerve, high myopia with eyeground pathological changes,etc.
- Patients with severe cardiovascular diseases, functional disorders of liver and kidneys, diseases of the haematopoietic system (bone marrow hypoplasia, leucopenia, anemia, etc.), severely abnormal electrocardiogram (ECG), ALT>2 *ULN, Cr >1.5*ULN and psychopaths.-Patients with diabetic nephropathy (DN) in the stage of azotemia or uremia.
- Pregnant women or trying to conceive or in lactation; patients with allergic constitution.
- Patients who have participated in other clinical trials in recent one month.
- Patients who have used the drugs in the treatment of diabetic retinopathy (calcium dobesilate, Difrarel, capsule of Xueshuantong, ginkgo biloba extract, Qiming granula, etc.) in past two weeks.
- Patients with SBP>160mmHg or DBP﹥100mmHg.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373476
Locations
| China, Beijing | |
| Beijing Tongren Hospital of Capital Medical University | |
| Beijing, Beijing, China | |
| China, Chongqing | |
| Daping Hospital of Third Military Medical University | |
| Chongqing, Chongqing, China | |
| China, Guangdong | |
| Guangdong Province Traditional Medical Hospital | |
| Guangzhou, Guangdong, China | |
| China, Hunan | |
| The first affiliated hospital of Hunan University of TCM | |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| Jiangsu Province Traditional Medical Hospital, | |
| Nanjing, Jiangsu, China | |
| China, Sichuan | |
| Affiliated Hospital of Chengdu University of TCM | |
| Chengdu, Sichuan, China | |
| West China Hospital | |
| Chengdu, Sichuan, China | |
| China | |
| The first affiliated hospital of Guangzhou university of TCM | |
| Guangzhou, China | |
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
Investigators
| Study Director: | Fuwen Zhang, Ph.D | Chengdu University of Traditional Chinese Medicine |
More Information
No publications provided
| Responsible Party: | Chengdu University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01373476 History of Changes |
| Other Study ID Numbers: | 2008L11200 |
| Study First Received: | April 26, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chengdu University of Traditional Chinese Medicine:
|
Diabetic Retinopathy Traditional Chinese medicine Diabetic Eye Problems Retinal Disorders |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013