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

This study has been completed.
Sponsor:
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

April 26, 2011
May 10, 2013
March 2011
March 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01373476 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Retinopathy
  • Diabetic Eye Problems
  • Retinal Disorders
  • 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.
  • Drug: Placebo Comparator
    Placebo group (4 placebos each time):4#, po, tid,24 weeks.
    Other Name: Placebo Comparator
  • Experimental: Qideng Mingmu capsule
    High dosage group,Middle dosage group,Low dosage group.
    Intervention: Drug: Qideng Mingmu capsule
  • Placebo Comparator: Placebo
    Placebo group
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01373476
2008L11200
Yes
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
Study Director: Fuwen Zhang, Ph.D Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP