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A randomized, double-blind, multi-center clinical study for the safety and efficacy of Xiaozheng Sanjie therapy for diabetic nephropathy (Mogensen IV stage) patients with Qi deficiency and blood stasis

A randomized, double-blind, multi-center clinical study for the safety and efficacy of Xiaozheng Sanjie therapy for diabetic nephropathy (Mogensen IV stage) patients with Qi deficiency and blood stasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021391
Enrollment
Unknown
Registered
2019-02-18
Start date
2019-03-30
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Diabetic Nephropathy

Interventions

Chinese medicine group:Xiaozheng Sanjie Formula Granule
Control group:Placebo

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients who were clinically diagnosed as DKD and met the DKD Mogensen IV stage Qi deficiency and blood stasis criteria, excluding the kidney injury caused by non-DKD diseases; 2. Gender is not limited, aged 25-75 years; 3. No dialysis treatment; 4. Serum creatinine was relatively stable within 3 months before enrollment, and the change was not more than 15%. 5. Western medicine lowered blood pressure by introducing DBP < 90 mmHg and SBP < 160 mmHg at the end of the period, and basic hypoglycemia by introducing HbA1c at the end of the period was between 6% and 9%. 6. The subjects agreed and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe infections, moderate to severe anemia, serious electrolyte disturbance, acid-base imbalance and acute complications of diabetes mellitus were found in the near future (within 4 weeks). 2. Severe heart, brain, liver and hematopoietic diseases (cerebral infarction, cerebral hemorrhage, transient ischemic attack, myocardial infarction, unstable angina pectoris, heart failure, transaminase elevation to the upper limit of normal range more than two times) and those who used glucocorticoid or immunosuppressive agents in the first three months of admission; 3. Oliguria or anuria, severe edema, pleural effusion and peritoneal effusion; 4. Plenty of proteinuria for 24h (>3.0g); 5. Renal transplantation; 6. A history of psychiatric disorders; 7. Pregnant or pregnant or lactating women; 8. Patients who are known to be allergic to the medication; 9. Hepatitis B examination showed positive e antigen. 10. Participating in other interventional clinical trials.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantification;serum creatinine;

Countries

china

Contacts

Public ContactZhou Jingwei

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

zjw_dzm@126.com+86 010 84013142

Outcome results

None listed

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