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| Name | Class |
|---|---|
| Chongqing Taiji Group of Fuling pharmaceutical Co., LTD | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qideng Mingmu capsule | Experimental | High dosage group,Middle dosage group,Low dosage group. |
|
| Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qideng Mingmu capsule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular fundus | Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fuwen Zhang, Ph.D | Chengdu University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital of Capital Medical University | Beijing | Beijing Municipality | China | |||
| Daping Hospital of Third Military Medical University |
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| Placebo Comparator | Drug | Placebo group (4 placebos each time):4#, po, tid,24 weeks. |
|
| 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. | 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. | 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. | 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. | at baseline phase and 12, 24 weeks after randomization |
| Chongqing |
| Chongqing Municipality |
| China |
| Guangdong Province Traditional Medical Hospital | Guangzhou | Guangdong | China |
| The first affiliated hospital of Hunan University of TCM | 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 |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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