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Clinical study on the treatment of diabetic nephropathy stage IV by Tripterygium wilfordii Hook F

Clinical study on the treatment of diabetic nephropathy stage IV by Tripterygium wilfordii Hook F

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17010623
Enrollment
Unknown
Registered
2017-02-13
Start date
2017-03-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Diabetic nephropathy

Interventions

experimental group:ARB drugs to the basal treatment plus Tripterygium wilfordii Hook F
Control:ARB drugs to the basal treatment

Sponsors

Beijing hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 40 to 70 years old male or female; (2) Voluntarily participate in this clinical study, the patients signed a written informed consent before the start of the study; (3) In accordance with the diagnostic criteria for diabetic nephropathy[37]; Consistent with the Mogensen phase IV, that is, persistent large amounts of albumin urine (urinary albumin excretion rate > 200 mu g/min or proteinuria greater than 500mg/d); (4) 24 hours urinary protein greater than or equal to 1g; (5) Estimated glomerular filtration rate (eGFR, calculated according to CKD-EPI formula) greater than or equal to 30mL/min/1.73m2 (equivalent to chronic kidney disease stage 1-3); (6) ARB drug therapy has been accepted and the patient's condition is stable. Selected patients shoud meet all of the above requirements.

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes mellitus or secondary diabetes mellitus; (2) Allergy to Tripterygium wilfordii Hook F; (3) The use of immunosuppressive agents other than Tripterygium wilfordii Hook F; (4) Pregnancy, breast-feeding or pregnancy, lactation in the course of the study; (5) Impaired liver function: Two times of ALT or AST levels exceed the upper limit of the normal value; (6) Blood white blood cell 180/100mmHg, and difficult to control; (8) Acute infection: happen within 1 month before the study; (9) Serum creatinine levels increased by more than 50%, or the inability to control the severe hyper potassium (serum potassium >6.0mmol/L), or unavailable use of such drugs,for example double renal artery stenosis; (10) Occurrence of serious cardiac and cerebral vascular events: heart failure, angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc within 6 months before the study; (11) Poor compliance (as judged by the investigator); (12) Participat in other drug clinical trials within 6 months before into the group; (13) Other researchers think that the situation is not suitable for the selected.

Design outcomes

Primary

MeasureTime frame
24 hour urine protein excretion;

Countries

China

Contacts

Public ContactMao Yonghui

Department of Nephrology, Beijing Hospital

mmdn2009@163.com+86 13910913875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026