the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of treatment with Traditional Chinese Medicine HuangQi Decoctions in Patients with early 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 Early Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine

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

Intervention / Treatment
-----------------
* Drug: HuangQi Decoction
* Drug: HuangQi 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 III; 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: HuangQi Decoction<br>HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks | Drug: HuangQi Decoction<br>* HuangQi Decoction 150ml twice a day for 24 weeks<br>* Other names: Astragalus and other TCMs Decoction;|
| Placebo Comparator: HuangQi Decoction placebo<br>HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks | Drug: HuangQi Decoction placebo<br>* traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks<br>* Other names: Astragalus Decoction placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR | the Urinary albumin/ creatinine ratios in stage Ⅲ diabetes kidney disease patients | 24 weeks | 

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