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

Phase 1

Recruiting

• Conditions: diabetic macular edema

• Registration Number: ITMCTR2100005414
• Lead Sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine(Jiangsu Province Hospital of Chinese Medicine)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. In accordance with the diagnostic criteria of type 2 diabetes, macular edema was diagnosed by OCT or FFA examination, the age was 18-75 years old, regardless of sex.
2. There were no acute complications of diabetes (hyperglycemia and hyperosmotic state of diabetes, diabetic ketoacidosis, etc.), fasting blood glucose (10mml/L) and blood pressure (150/90mmHg).
3. TCM syndrome differentiation is deficiency of both qi and yin, dampness and blood stasis blocking collaterals.
4. Informed consent, volunteer subjects. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion Criteria

1. Previous history of ocular trauma, vitreous surgery, glaucoma, FFA with uveitis or other retinal diseases. 2. Recently, there are serious systemic diseases such as myocardial infarction, cerebral infarction and severe refractive interstitial opacity that affect fundus observation.
3. Patients with diabetic macular edema who have received intravitreal or peribulbar injection of corticosteroids.
4. The poor image quality can not complete the image analysis.
5. History of thromboembolism, abnormal blood coagulation, ongoing use of anticoagulants (except aspirin), or other serious systemic diseases.
6. A person who is unable to give full informed consent due to intellectual or behavioral impairment.
7. Suspect or have a history of alcohol or drug abuse.
8. According to the judgment of the researchers, other pathological changes that reduce or complicate the possibility of enrollment, such as frequent changes in the working environment, are easy to cause loss of follow-up.
9. Allergic constitution, such as those who have a history of allergy to two or more drugs or food; or those who are known to be allergic to the ingredients of this drug.
10. Patients who are participating in clinical trials of other drugs.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
best corrected vision acuity;central Retinal thickness;

Secondary Outcome Measures

Name	Time	Method
superficial capillary plexus-retinal vascular density;