Diabetic Nephropathy Type 2
Conditions
Keywords
Diabetic Kidney Disease，Traditional Chinese medicine
Brief summary
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.
Detailed description
The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.
Interventions
DRUGShenqiDihuang Decoction
ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks
DRUGShenqiDihuang Decoction placebo
traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Identify the diagnosis of type 2 diabetes; 2. It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV; 3. eGFR ≥ 30 ml / min / 1.73 m2; 4. Age 18-75 years old, gender ＆ethnicity are not limited; 5. glycated hemoglobin ≤ 10%; 6. Blood pressure is controlled below 130/80mmHg
Exclusion criteria
1. Combine other ACEI and ARB application indications other than hypertension; 2. Combine severe primary diseases related to heart, brain, liver and hematopoietic system; 3. Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month; 4. Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities; 5. Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents; 6. Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states; 7. pregnant or lactating women; 8. Patients who accepted other clinical trial studies on going ; 9. Patients who combined with serious diseases and dysfunctions in other organs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24H urine total protein | 24 weeks | t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients |
Countries
China
Outcome results
None listed