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
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Diabetic Eye Problems
Retinal Disorders
Drug: Qideng Mingmu capsule
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 240
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qideng Mingmu capsule
High dosage group,Middle dosage group,Low dosage group.
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.
Placebo Comparator: Placebo
Placebo group
Drug: Placebo Comparator
Placebo group (4 placebos each time):4#, po, tid,24 weeks.
Other Name: Placebo Comparator

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373476

Locations
China, Beijing
Beijing Tongren Hospital of Capital Medical University
Beijing, Beijing, China
China, Chongqing
Daping Hospital of Third Military Medical University
Chongqing, Chongqing, China
China, Guangdong
Guangdong Province Traditional Medical Hospital
Guangzhou, Guangdong, China
China, Hunan
The first affiliated hospital of Hunan University of TCM
Changsha, Hunan, China
China, Jiangsu
Jiangsu Province Traditional Medical Hospital,
Nanjing, Jiangsu, China
China, Sichuan
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
China
The first affiliated hospital of Guangzhou university of TCM
Guangzhou, China
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
Investigators
Study Director: Fuwen Zhang, Ph.D Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01373476     History of Changes
Other Study ID Numbers: 2008L11200
Study First Received: April 26, 2011
Last Updated: May 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Diabetic Retinopathy
Traditional Chinese medicine
Diabetic Eye Problems
Retinal Disorders

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014