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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
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 group (4 placebos each time):4#, po, tid,24 weeks.
Beijing Tongren Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Daping Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Guangdong Province Traditional Medical Hospital
Guangzhou, Guangdong, China
The first affiliated hospital of Hunan University of TCM
Ocular fundus
Time frame: Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months
Fundus fluorescein angiography (FFA)
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).
Time frame: at baseline phase and 24 weeks after randomization
best-corrected ETDRS visual acuity
best-corrected ETDRS visual acuity will be captured at baseline phase and every four weeks after randomization.
Time frame: at baseline phase and every four weeks after randomization.
Traditional Chinese medical (TCM) syndrome scores
Traditional Chinese medical (TCM) syndrome scores will be collected at baseline phase and every four weeks after randomization.
Time frame: at baseline phase and every four weeks after randomization.
the observation of Ocular fundus
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.
Time frame: at baseline phase and 12, 24 weeks after randomization
Optic coherence tomography (OCT)
Optic coherence tomography (OCT) is to be tested at baseline phase and 12, 24 weeks after randomization, indicating the degree of macular edema.
Time frame: at baseline phase and 12, 24 weeks after randomization
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Changsha, Hunan, China
Jiangsu Province Traditional Medical Hospital,
Nanjing, Jiangsu, China
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
The first affiliated hospital of Guangzhou university of TCM
Guangzhou, China