the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Study Overview
=================
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.

Official Title
-----------------
Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine

Conditions
-----------------
Diabetic Nephropathy Type 2

Intervention / Treatment
-----------------
* Drug: ShenqiDihuang Decoction
* Drug: ShenqiDihuang Decoction placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identify the diagnosis of type 2 diabetes; It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV; eGFR ≥ 30 ml / min / 1.73 m2; Age 18-75 years old, gender ＆ethnicity are not limited; glycated hemoglobin ≤ 10%; Blood pressure is controlled below 130/80mmHg Exclusion Criteria: Combine other ACEI and ARB application indications other than hypertension; Combine severe primary diseases related to heart, brain, liver and hematopoietic system; Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month; Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities; 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; Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states; pregnant or lactating women; Patients who accepted other clinical trial studies on going ; Patients who combined with serious diseases and dysfunctions in other organs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ShenqiDihuang Decoction<br>ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks | Drug: ShenqiDihuang Decoction<br>* ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks<br>* Other names: nseng, Astragalus, Rehmannia and other TCMs Decoction;|
| Placebo Comparator: ShenqiDihuang Decoction placebo<br>ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks | Drug: ShenqiDihuang Decoction placebo<br>* traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks<br>* Other names: Ginseng, Astragalus, Rehmannia Decoction placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24H urine total protein | t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Kidney Disease，Traditional Chinese medicine