the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

Phase 1

Completed

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

• Registration Number: NCT03681704
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2018-11-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 III;
3. Age 18-75 years old, gender ＆ethnicity are not limited;
4. glycated hemoglobin ≤ 10%;
5. 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
HuangQi Decoction	HuangQi Decoction	HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks
HuangQi Decoction placebo	HuangQi Decoction placebo	HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks

Primary Outcome Measures

Name	Time	Method
ACR	24 weeks	the Urinary albumin/ creatinine ratios in stage Ⅲ diabetes kidney disease patients

Trial Locations

Locations (1)

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