About this trial
The purpose of the study is to evaluate the efficacy of Keluoxin Capsules for the treatment of diabetic kidney disease (DKD) and diabetic retinopathy (DR) compared to placebo on a conventional treatment basis.
Eligibility criteria
Qualifiers
Age: 18-75 years old, either sex;
Meeting the diagnostic criteria for type 2 diabetes mellitus and DKD;
The target eye met the diagnostic criteria for type 2 DR and the fundus showed moderate or severe NPDR;
Have been treated with an adequate dose of RAASIs for more than 4 weeks;
Disqualifiers
Patients with a known or suspected history of allergy to the test drug and its excipients;
Various primary kidney diseases or non-diabetic kidney disease as judged by the investigator;
Heat-toxin syndrome: swelling and pain the throat , redness, swelling, and pain in the eyes, mouth and tongue sores, swollen and painful gums, cough with yellow phlegm, stool stem nod, deep colored urine, red tongue with yellow coating; cold-dampness syndrome: poor appetite, borborygmus, diarrhoea, drowsiness, clear urine in large amounts and high frequency, menstrual disorders, aversion to cold and cold limbs; meet the either manifestation of heat-toxin syndrome or cold-dampness syndrome, that is, the need to be excluded;
Received periocular corticosteroid injections within 3 months prior to screening;
Trial design
Treatments tested in this trial
- Keluoxin Capsules
- Keluoxin Capsule Simulants
- Irbesartan