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A prospective, single-center, randomized controlled study of the efficacy of oral berberine hydrochloride in the treatment of diabetic nephropathy

Curative effect of berberine hydrochloride on diabetic nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083889
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Diabetic Nephropathy

Interventions

Control:Patients with diabetes who met the inclusion criteria received standard hypoglycemic therapy and standard dose of ACEI or ARB therapy
Berberine treatment group:Patients with diabetes who met the inclusion criteria were treated with standard hypoglycemic therapy, standard dose of ACEI or ARB and berberine (0.5 g BID)
Positive drug group:Patients with diabetes who met the inclusion criteria were treated with standard hypoglycemic therapy, standard dose of ACEI or ARB, and oral dagaglizin (10mg QD)

Sponsors

First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, gender is not limited; (2) Clinical diagnosis of diabetic nephropathy, blood glucose control standard (baseline level of glycosylated hemoglobin < 7.0%); (3) The degree of renal insufficiency was mild (eGFR<90ml/min/(1.73m²) but =60ml/min/(1.73m²) or urinary albumin/urinary creatinine (UACR) =30mg/g); (4) Berberine or daglizin treatment for patients whose subjects or their legal representatives have consented to the treatment and signed informed consent for the project.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications for berberine, ACEI/ARB or daglizin; (2) Newly diagnosed diabetic patients; (3) Those who have been judged by endocrinologists as having poor blood sugar control; (4) Pregnant or lactating women; (5) Patients with a history of using drugs to improve renal function (diuretics, glucocorticoids and proprietary Chinese medicines for protecting kidney, etc.) within the past 6 months; (6) Patients with anemia, severe liver insufficiency, infection or other diseases (such as malignant tumors, organ transplantation) or a history of drug abuse; (7) Patients with a life expectancy of less than 3 months or who are unable to complete the study for other reasons; (8) Unwilling to be followed up or poor treatment compliance; (9) are participating in other clinical investigators, or have participated in other clinical investigators within 3 months before enrollment, or have participated in this investigator; (10) Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Creatinine;

Secondary

MeasureTime frame
Blood Urea Nitrogen;Blood Routine;Serum Lipid;Fingertip Blood Glucose;Glycosylated Hemoglobin;

Countries

China

Contacts

Public ContactQian Tong

First Hospital of Jilin University

tongqian@jlu.edu.cn+86 158 0430 0981

Outcome results

None listed

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