Type 2 Diabetic Kidney Disease.
Conditions
Interventions
A group:1*TBN tablets(300mg)+3*placebo tablets
B group:2*TBN tablets(300mg)+2*placebo tablets
C group:4*TBN tablets(300mg)
D group:4*placebo tablets
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, patient aged from 18 to 75 years inclusive; 2. Diagnosed with type 2 Diabetes. If the patient is under 30 years of age, he/she need to test the serum C-peptide level to confirm the diagnosis; 3. Glycosylated?HbA1c = 30 mg/g (3.39 mg/mmol) and 60 mL/min/1.73 m2 (modified MDRD adapted to Chinese people); 5. Blood pressure <= 160/100 mmHg, controlled under 160/100 mmHg with appropriate treatment before randomization; 6. Willing to take effective contraceptive measures from the date of signing of written informed consent until 6 months after the last dose; 7. Willing to participate and sign informed consent, and able to understand and follow the process of this trial. ICF could be signed by subjects themselves or his/her legally acceptable representative.
Exclusion criteria
Exclusion criteria: 1. Within 2 weeks before randomization, the patient taking kidney protective Chinese patent medicine and cannot stop the treatment during the study. Chinese patent medicine only refers to ShenYanLingKeLi, NiaoDuQingKeLi, FufangShenyanPian, ShenYanKangFuPian and Huangkuijiaonang; 2. Within 2 weeks before randomization, the patient taking GLP-1 receptor agonists and cannot stop during the study; 3. Within 2 weeks before randomization, the patient who is taking immunosuppressive drugs and cannot stop during the study, except for intra-articular injection, inhalant, and nasal spray; 4. Abnormal liver test results (refers to AST or/and ALT or/and ALP > 3 x ULN) when screening, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis. 5. Patients with acute or chronic urinary tract infection within 2 weeks before randomization; 6.Concomitant Chronic renal disease such as glomerulonephritis, pyelonephritis, Ischemic nephropathy, Gouty nephropathy, etc. 7. A medical history of familial glucose-galactose malabsorption or primary renal glycosuria; 8. A clear medical history of severe acute complications of diabetes (Ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma) within 6 months before screening. 9. A medical history of organ transplant, such as Liver transplantation, kidney transplantation, etc; 10.Received dialysis treatment for acute renal failure within 6 months prior to screening; 11. Medical history of non-traumatic amputation within 12 months before screening or history of diabetic foot(Wagner III-V), osteomyelitis, and lower limb ischemia; 12. A medical history of acute coronary syndrome, heart failure (NYHA III-IV), heart-related diseases surgery, and poor prognosis of stroke (mRS > 1) within 6 months prior to screening; 13. Had a history of autoimmune diseases like systemic lupus erythematosus etc; 14. Had a medical history of a malignant tumor or receiving treatment for cancer within 5 years before randomization; 15. Inability or unwillingness to co-operate due to concomitant mental illness, neurological impairment, or language impairment; 16. History of allergy to ligustrazine and excipients of study drug (mannitol, hydroxypropyl cellulose, cross-linked polyvitone, talcum powder, sodium bicarbonate, magnesium stearate, methacrylate-ethyl acrylate copolymer, triethyl citrate, titanium dioxide); 17. Had participated in other drug clinical trials within 3 months prior to screening; 18. Pregnant or lactating female, or women of childbearing age with positive pregnancy test results; 19. The investigator determined that the subject was not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| UACR;eGFR;Cystatin C;HbA1c;GLU;PK parameters of TBN and its major metabolite in plasma; | — |
Countries
China
Contacts
Public ContactJinkui Yang
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed