Clinical trial NCT01373476: Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Diabetic Eye Problems
Retinal Disorders
Keywords: Diabetic Retinopathy
Traditional Chinese medicine
Diabetic Eye Problems
Retinal Disorders
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
First posted: 2011-06-15
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Ocular fundus
timeFrame: Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months
Secondary outcomes:
measure: Fundus fluorescein angiography (FFA)
timeFrame: at baseline phase and 24 weeks after randomization
measure: best-corrected ETDRS visual acuity
timeFrame: at baseline phase and every four weeks after randomization.
measure: Traditional Chinese medical (TCM) syndrome scores
timeFrame: at baseline phase and every four weeks after randomization.
measure: the observation of Ocular fundus
timeFrame: at baseline phase and 12, 24 weeks after randomization
measure: Optic coherence tomography (OCT)
timeFrame: at baseline phase and 12, 24 weeks after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital of Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital of Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Province Traditional Medical Hospital
state: Guangdong
city: Changsha
country: China
facility: The first affiliated hospital of Hunan University of TCM
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Traditional Medical Hospital,
state: Jiangsu
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of TCM
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou university of TCM
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Fuwen Zhang, Ph.D
role: STUDY_DIRECTOR
References: