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

NCT01373476 | Completed Phase 2 DMC

• 1 other identifier: 2008L11200
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Diabetic Retinopathy; Diabetic Eye Problems; Retinal Disorders

Keywords

Diabetic Retinopathy; Traditional Chinese medicine; Diabetic Eye Problems; Retinal Disorders

Outcome Measures

Primary Outcomes (1)

• Ocular fundus

  Change from Baseline in Ocular fundus which is to be examined by color fundus image at 6 months

Secondary Outcomes (5)

• Fundus fluorescein angiography (FFA)

  at baseline phase and 24 weeks after randomization

• best-corrected ETDRS visual acuity

  at baseline phase and every four weeks after randomization.

• Traditional Chinese medical (TCM) syndrome scores

  at baseline phase and every four weeks after randomization.

• the observation of Ocular fundus

  at baseline phase and 12, 24 weeks after randomization

• Optic coherence tomography (OCT)

  at baseline phase and 12, 24 weeks after randomization

Study Arms (2)

Qideng Mingmu capsule

EXPERIMENTAL

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

Drug: Qideng Mingmu capsule

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo Comparator

Interventions

Qideng Mingmu capsule DRUG

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.

Qideng Mingmu capsule

Placebo Comparator DRUG

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

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• Chongqing Taiji Group of Fuling pharmaceutical Co., LTD: collaborator

Study Sites (8)

Beijing Tongren Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Daping Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, China

Location

Guangdong Province Traditional Medical Hospital

Guangzhou, Guangdong, China

Location

The first affiliated hospital of Hunan University of TCM

Changsha, Hunan, China

Location

Jiangsu Province Traditional Medical Hospital,

Nanjing, Jiangsu, China

Location

Affiliated Hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

The first affiliated hospital of Guangzhou university of TCM

Guangzhou, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Fuwen Zhang, Ph.D

  Chengdu University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: June 15, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

CN (8)