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Effcacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis: a Multicenter Randomized Controlled Clinical Trial

Effcacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis: a Multicenter Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003199
Enrollment
Unknown
Registered
2020-04-08
Start date
2020-04-30
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Chronic Kidney Disease

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old and = 15mL/min/1.73 m2 (2012 KDIGO standard); 4. 24-hour urinary protein quantification < 3g during the screening period; 5. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L; 6. Patients who have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women, and women of reproductive age who are unwilling to take reliable contraceptive measures; 2. Patients with known allergy to Jinshuibao; 3. Natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment were used in two weeks before enrollment; 4. Patients who received glucocorticoids, immunosuppressants or tripterygium wilfordii preparations 3 months prior to enrol, or patients who have been confirmed to receive glucocorticoids, immunosuppressants or tripterygium wilfordii preparations; 5. Patients with gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II and below), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea and gastrointestinal surgery; 6. With a history of organ transplant, including kidney transplant; 7. With severe diseases of the heart, brain, liver and hematopoietic system or other serious diseases affecting survival: for example, patients with known malignant tumors, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack occurred within 6 months; 8. For patients whose disease progresses too rapidly as judged by the clinician, such as eGFR decreases by more than 5ml/min/1.73m2 in the previous year; 9. Patients who participated in other clinical trials within 3 months; 10. In addition to the above, patients who evaluated by the researchers are not eligible to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Change from baseline in estimated glomerular filtration rate;

Secondary

MeasureTime frame
Number of rehospitalizations during the follow-up period;Quality of life;Change from baseline in TNF-a, IL-1ß, and IL-6;Change from baseline in urinary protein/creatinine ratio (PCR);the time and incidence of ESRD or a 50% decrease in eGFR;Change from baseline in creatinine and 24-hour urine protein;Change from baseline in hs-CRP;

Countries

China

Contacts

Public ContactWang Niansong

Shanghai Sixth People's Hospital

jsb_med@126.com+86 21-64879163

Outcome results

None listed

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