Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00904592
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with diabetes mellitus.
* Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy
* and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125).
* Diagnosed with the syndrome and signs of TCM.
* HbA1C≤8.0%.
* Ages ranged from 35 to 75 years.
* Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion Criteria:
* Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.
* The patients who have been received the therapy of Retina laser photocoagulation.
* The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.
* DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.
* Combined with other severe Diabetic complication.
* Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness
* Pregnant or breast feeding.
* combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis.
* Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
* Participated in other clinical trial within 3 month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00904592
Study Brief:
Protocol Section:
NCT00904592