the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

Multicenter Clinical Study on the Treatment of Early Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03681704

Enrollment

Registered

2018-09-24

Start date

2018-11-08

Completion date

2021-12-31

Last updated

2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy Type 2

Keywords

Diabetic Kidney Disease，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.

Interventions

DRUGHuangQi Decoction

HuangQi Decoction 150ml twice a day for 24 weeks

DRUGHuangQi Decoction placebo

traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 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.

Design outcomes

Primary

Measure	Time frame	Description
ACR	24 weeks	the Urinary albumin/ creatinine ratios in stage Ⅲ diabetes kidney disease patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026