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Randomized controlled study on the prevention and treatment of moderate and severe non-proliferative glucose network visual impairment in spleen-kidney-Yang deficiency type

Randomized controlled study on the prevention and treatment of moderate and severe non-proliferative glucose network visual impairment in spleen-kidney-Yang deficiency type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000334
Enrollment
Unknown
Registered
2024-08-31
Start date
2022-04-10
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Diabetic retinopathy

Interventions

Chinese medicine group:Oral Chinese prescription decoction
Calcium isobenesulfonate Group:Oral calcium isobenesulfonate capsules

Sponsors

Eye Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
41 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a type 2 diabetes diagnosis; 2.3 Fluoroscopy within a month was consistent with the diagnostic criteria for moderate to severe non-proliferative diabetic retinopathy; 3. Aged between 40 years old (excluding) and 70 years old (excluding); 4. Patients without fundus laser treatment; 5. TCM syndrome differentiation of spleen-kidney Yang deficiency; 6. Signed informed consent. 7. Blood glucose control is relatively stable, with fasting blood glucose < 7.0 mmol/L or 2 h postprandial blood glucose < 9.0 mmol/L

Exclusion criteria

Exclusion criteria: 1. Poor refractive interstitial clarity, difficult to perform fundus observer; 2. Patients with macular hole, glaucoma, retinal vein obstruction, uveitis, optic nerve disease and other fundus diseases; 3. Patients with severe cardiovascular, cerebrovascular, liver and hematopoietic diseases and diabetic nephropathy with renal failure; 4. Patients with serious life-threatening primary diseases and mental illness; 5. Pregnant or lactating women; 6. Those who are participating in clinical trials of other drugs; 7. The inspection process can not cooperate; 8. Failure to follow up fundus examination. 9. People who are taking drugs that may affect the evaluation of clinical efficacy

Design outcomes

Primary

MeasureTime frame
Morphological changes of the fovea without blood vessels and changes of blood flow density in the macular region;Fundus photographic image analysis;Best Corrected Visual Acuity(BCVA);Retinal mean light acuity (MS), fixation stability;—

Secondary

MeasureTime frame
TCM syndrome integral;—

Countries

China

Contacts

Public ContactJing Yan

Eye Hospital of China Academy of Chinese Medical Sciences

yjfly8377@sina.com+86 136 1117 7527

Outcome results

None listed

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