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

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373476
• Other study ID #: 2008L11200
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2011
• Last updated: May 10, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Eye Problems
• Diabetic Retinopathy
• Retinal Diseases
• Retinal Disorders

Intervention

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 group (4 placebos each time):4#, po, tid,24 weeks.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Chongqing Taiji Group of Fuling pharmaceutical Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular fundus		Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months	No
Secondary	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).	at baseline phase and 24 weeks after randomization	No
Secondary	best-corrected ETDRS visual acuity	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.	No
Secondary	Traditional Chinese medical (TCM) syndrome scores	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.	No
Secondary	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.	at baseline phase and 12, 24 weeks after randomization	No
Secondary	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.	at baseline phase and 12, 24 weeks after randomization	No