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

Primary Purpose

Diabetic Retinopathy, Diabetic Eye Problems, Retinal Disorders

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Qideng Mingmu capsule
Placebo Comparator
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Traditional Chinese medicine, Diabetic Eye Problems, Retinal Disorders

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qideng Mingmu capsule

Placebo

Arm Description

High dosage group,Middle dosage group,Low dosage group.

Placebo group

Outcomes

Primary Outcome Measures

Ocular fundus

Secondary Outcome Measures

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).
best-corrected ETDRS visual acuity
best-corrected ETDRS visual acuity will be captured 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.
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.
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.

Full Information

First Posted
April 26, 2011
Last Updated
May 10, 2013
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT01373476
Brief Title
Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Chongqing Taiji Group of Fuling pharmaceutical Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetic Eye Problems, Retinal Disorders
Keywords
Diabetic Retinopathy, Traditional Chinese medicine, Diabetic Eye Problems, Retinal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qideng Mingmu capsule
Arm Type
Experimental
Arm Description
High dosage group,Middle dosage group,Low dosage group.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Qideng Mingmu capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo group (4 placebos each time):4#, po, tid,24 weeks.
Primary Outcome Measure Information:
Title
Ocular fundus
Time Frame
Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months
Secondary Outcome Measure Information:
Title
Fundus fluorescein angiography (FFA)
Description
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).
Time Frame
at baseline phase and 24 weeks after randomization
Title
best-corrected ETDRS visual acuity
Description
best-corrected ETDRS visual acuity will be captured at baseline phase and every four weeks after randomization.
Time Frame
at baseline phase and every four weeks after randomization.
Title
Traditional Chinese medical (TCM) syndrome scores
Description
Traditional Chinese medical (TCM) syndrome scores will be collected at baseline phase and every four weeks after randomization.
Time Frame
at baseline phase and every four weeks after randomization.
Title
the observation of Ocular fundus
Description
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.
Time Frame
at baseline phase and 12, 24 weeks after randomization
Title
Optic coherence tomography (OCT)
Description
Optic coherence tomography (OCT) is to be tested at baseline phase and 12, 24 weeks after randomization, indicating the degree of macular edema.
Time Frame
at baseline phase and 12, 24 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuwen Zhang, Ph.D
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tongren Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Daping Hospital of Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Guangdong Province Traditional Medical Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The first affiliated hospital of Hunan University of TCM
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Traditional Medical Hospital,
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The first affiliated hospital of Guangzhou university of TCM
City
Guangzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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