Clinical Trial: Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 S

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 Summary: 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.
Sponsor: Chengdu University of Traditional Chinese Medicine

Current Primary Outcome: Ocular fundus [ Time Frame: Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fundus fluorescein angiography (FFA) [ Time Frame: at baseline phase and 24 weeks after randomization ]
    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. ]
    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. ]
    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 ]
    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 ]
    Optic coherence tomography (OCT) is to be tested at baseline phase and 12, 24 weeks after randomization, indicating the degree of macular edema.


Original Secondary Outcome: Same as current

Information By: Chengdu University of Traditional Chinese Medicine

Dates:
Date Received: April 26, 2011
Date Started: March 2011
Date Completion:
Last Updated: May 10, 2013
Last Verified: May 2013