Clinical trial NCT03681249: the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD
Official title: Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetic Nephropathy Type 2
Keywords: Diabetic Kidney Disease，Traditional Chinese medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
First posted: 2018-09-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24H urine total protein
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yueyi Deng, PhD
role: PRINCIPAL_INVESTIGATOR
References: