Skip to content

Clinical study on the intervention effect of resolving dampness and activating blood circulation on CI-DME

Clinical study on the intervention effect of resolving dampness and activating blood circulation on CI-DME based on the Regulation of cathepsinD

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054410
Enrollment
Unknown
Registered
2021-12-17
Start date
2021-12-17
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

diabetic macular edema

Interventions

Experimental group:anti-VEGFtherapy+Prescription for resolving dampness and activating blood circulation

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for type 2 diabetes, diagnosed with macular edema by OCT or FFA, aged 18 to 75 years, and gender is not limited; 2. No acute complications of diabetes (diabetic hyperglycemia and hyperosmolar state, diabetic ketoacidosis, etc.), fasting blood glucose <= 10mml/L, blood pressure <= 150/90 mmHg; 3. TCM syndrome differentiation is deficiency of both qi and yin, dampness and blood stasis blocking collaterals; 4. Informed consent, volunteer experiment. The process of obtaining informed consent should comply with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. History of ocular trauma, vitreous surgery, glaucoma, uveitis or other retinal diseases found in FFA examination; 2. Recent history of myocardial infarction, cerebral infarction and other serious systemic diseases and severe refractive interstitial opacities that affect fundus observation; 3. Patients with diabetic macular edema who have received intravitreal or peribulbar injection of glucocorticoids; 4. Poor image quality cannot complete image analysis; 5. Thromboembolism, abnormal coagulation function, using anticoagulant drugs (except aspirin), or a history of other serious systemic diseases; 6. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 7. Suspect or have a history of alcohol or drug abuse; 8. According to the judgment of the investigator, other diseases that reduce the possibility of enrolling or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss to follow-up; 9. Allergic constitution, such as those with a history of two or more drug or food allergies; or those who are known to be allergic to the ingredients of this medicine; 10. Patients who are participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
central Retinal thickness;best corrected vision acuity;

Secondary

MeasureTime frame
superficial capillary plexus-retinal vascular density;

Countries

China

Contacts

Public ContactWu Hao

Affiliated Hospital of Nanjing University of Chinese Medicine

hal20151317@163.com+86 15950570210

Outcome results

None listed

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