Diabetic Nephropathy Type 2 Clinical Trial
Official title:
Multicenter Clinical Study on the Treatment of Early Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
Verified date | May 2022 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficacy and Safety of treatment with Traditional Chinese Medicine HuangQi Decoctions in Patients with early stage of Diabetic Kidney Disease.
Status | Completed |
Enrollment | 96 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 III; 3. Age 18-75 years old, gender ðnicity are not limited; 4. glycated hemoglobin = 10%; 5. 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. |
Country | Name | City | State |
---|---|---|---|
China | Longhua Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai University of Traditional Chinese Medicine | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR | the Urinary albumin/ creatinine ratios in stage ? diabetes kidney disease patients | 24 weeks |
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