the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Early Phase 1

Completed

• Conditions: Diabetic Nephropathy Type 2
• Interventions: Drug: ShenqiDihuang Decoction placebo; Drug: ShenqiDihuang Decoction

• Registration Number: NCT03681249
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2018-11-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
24H urine total protein	24 weeks	t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients

Trial Locations

Locations (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China