the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Early Phase 1

Conditions: Diabetic Nephropathy Type 2

Treatments: Drug: ShenqiDihuang Decoction placebo; Drug: ShenqiDihuang Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT03681249

17401970500-b

Details and patient eligibility

About

Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

ShenqiDihuang Decoction

Experimental group

Description:

ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks

Treatment:

Drug: ShenqiDihuang Decoction

ShenqiDihuang Decoction placebo

Placebo Comparator group

Description:

ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks

Treatment:

Drug: ShenqiDihuang Decoction placebo