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Clinical study of Treatment with kudiezi Injection in nonproliferative diabetic retinopathy Patients

Clinical study of Treatment with kudiezi Injection in nonproliferative diabetic retinopathy Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002122
Enrollment
Unknown
Registered
2012-04-23
Start date
2012-04-23
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonproliferative diabetic retinopathy

Interventions

Group A:1. Therapy for diabetes mellitus: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education, taking calcium dobesilate tablets. 2 kudie
Group B:Basic therapy and placebo: 1. Therapy for diabetes mellitus: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education, taking calcium
2. placebo

Sponsors

The Eye Hospital of Xingtai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
36 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of diabetic mellitus; 2. Meet the diagnostic criteria of non-proliferative diabetic retinopathy, and belongs to light and medium stage of the disease; 3. Patient who is 36-70 years old; 4. Informed consent and voluntarily take part in this trial,signed consent form.

Exclusion criteria

Exclusion criteria: The patients who meet one of the following criteria should not enter the study. 1. Allergic to kudiezi injection; 2. Combined with the other serious complications of diabetes; 3. With other eye diseases sush as glaucoma, uveitis, optic neuropathy and severe cataract; 4. Failure to evaluate eye image of the tested eye with severe opacity of refractive media; 5. With severe primary diseases such as cardiovascular, liver or kidney disease, or hematopoietic system disease; 6. Mental disease or cognitive impairment patients; 7. Pregnant, lactating women, or Prepare gravid; 8. Participated (within three months) in or are in other clinical trials; 9. Other reasons not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
1. General reaction;2. Blood routine examination;3. Urine routine examination;4. Liver function test. 5. Renal function;Visual electro physiology examination: FERG, OPs;Vision and eye fundus examination;visual field;angiography fiurescence fundus;Hemodynamic Study of Optic Artery;hemorheolog;

Contacts

Public ContactYang Zanzhang
yangzanzhang@163.com+86 15100896243

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026