Diabetic nephropathy Astragalus membranaceus,
Conditions
Interventions
conventional treatments,Astragalus membranaceus (Fisch.) Bunge extract containing Astragaloside IV (Nephrotec® 300mg capsules) two times a day together with the conventional treatments
Active Comparator Drug,Experimental Drug
Sponsors
FAME Pharmaceuticals Industry Co., Ltd.
FAME Pharmaceuticals Industry Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diabetic nephropathy patients (new cases) with urinary albumin-to-creatinine ratio ≥30 mg/g and/or sustained reduction in eGFR below 60 ml/min/1.73 m2 2. Aged 18 years and above
Exclusion criteria
Exclusion criteria: 1. Prior history of taking Astragalus membranaceus extract and ACEI/ARB 2. Patients with history of allergy to Astragalus membranaceus 3. Pregnant women and lactating mothers 4. Patients with the history of autoimmune diseases 5. Patients with the history of other causes of nephropathy such as obstructive uropathy, hypertension, SLE, glomerulonephritis and polycystic kidney disease 6. Patients on steroids and/or immunosuppressive agents 7. Patients with acute renal failure and renal transplant recipient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate (eGFR) Baseline, 1,2,3 and 6 month follow-ups CKD EPI equation, serum creatinine,Urinary albumin-to-creatinine ratio (UACR) Baseline, 1,2,3 and 6 month follow-ups Urine test | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life Baseline, 3 and 6 month follow-ups SF-36 questionnaire, face-to-face interview | — |
Countries
Myanmar
Contacts
Public ContactYe Htut Linn
FAME Pharmaceuticals Industry Co., Ltd.
Outcome results
None listed