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the Clinical Research for Effectivity and Safety of Modified Hu-Lu-Ba-Wan in the treatment of Diabetic Kidney Disease

the Clinical Research for Effectivity and Safety of Modified Hu-Lu-Ba-Wan in the treatment of Diabetic Kidney Disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024435
Enrollment
Unknown
Registered
2019-07-11
Start date
2019-07-10
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Diabetic Kidney Disease

Interventions

Sponsors

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Accord to the western diagnostic criteria for type 2 diabetes, or previous history of diabetes; 2. Phase III DKD standard, the screening and early detection of urinary albumin/creatinine ratio (ACR) are accord with 30 ~ 300 mg/g; 3. Syndrome differentiation of TCM syndrome type is kidney Yang deficiency; 4. Normal serum creatine; 5. After basic treatment, blood glucose was controlled in HbA1c < 8.5%, FPG < 9mmol/L, 2h postprandial blood glucose < 13.0mmol/L, and blood pressure was controlled in < 140/90mmhg. 6. Male and female aged 25-70 years old; 7. Sign informed consent form.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes; 2. Patients with severe primary cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and hematopoietic system diseases; 3. Infection, severe electrolyte disorder and other aggravating factors which are not controlled or the patients whose conditions are unstable; 4. Excluding patients with a variety of primary and secondary renal diseases and diseases caused by hypertension, heart failure, acidosis and urinary tract infection with increased urinary protein; 5. Mentally ill; 6. Women who are pregnant or preparing for pregnancy or lactation; 7. Patients who need long-term hormone therapy; 8. Hypertension that is difficult to control, or secondary hypertension; 9. The patients who the investigator expects poor compliance or inability to cooperate.

Design outcomes

Primary

MeasureTime frame
TCM syndrone score;ACR;

Secondary

MeasureTime frame
Fasting blood-glucose;HbA1c;Blood fat;eGFR;Urine targeted metabolomics;The number of urinary foot cells and the expressions of pcx-1, nephrin and CD2AP in urinary sediment;

Countries

China

Contacts

Public ContactLu Fuer

Department of Integrated Traditional Chinese and Western Clinical Medicine, Tongji Hospital, Tongji Medical College, Hua Zhong University of Science and Technology

felu@tjh.tjmu.edu.cn+86 13995523896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026