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

May 10, 2013 updated by: Chengdu University of Traditional Chinese Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou University of TCM
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tongren Hospital of Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • Daping Hospital of Third Military Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Province Traditional Medical Hospital
    • Hunan
      • Changsha, Hunan, China
        • The first affiliated hospital of Hunan University of TCM
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Traditional Medical Hospital,
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital
      • Chengdu, Sichuan, China
        • Affiliated Hospital of Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo group
Drug: Placebo Comparator
Placebo group (4 placebos each time):4#, po, tid,24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline phase and 24 weeks after randomization
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.
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.
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.
at baseline phase and 12, 24 weeks after randomization
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.
at baseline phase and 12, 24 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Chongqing Taiji Group of Fuling pharmaceutical Co., LTD

Investigators

  • Study Director: Fuwen Zhang, Ph.D, Chengdu University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (ESTIMATE)

June 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008L11200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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