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A multicenter randomized controlled trial of Sanhuang Yishen Capsules in combination with Nonaribon tablets for the treatment of diabetic kidney disease.

A multicenter randomized controlled trial of Sanhuang Yishen Capsules in combination with Nonaribon Tablets for the treatment of diabetic kidney disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001989
Enrollment
Unknown
Registered
2026-08-11
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-10-05

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

Conditions

Diabetic Nephropathy

Interventions

Control Group:(1) Diabetes health education, including a low-sodium, low-fat, high-quality low-protein diet with protein intake of 0.8 g/kg/day, and dietary sodium intake <2 g/day
and psychological counseling for patients to actively cooperate with this treatment. (2) Basic drug therapy: If blood glucose control is unsatisfactory, according to the recommendations of the "Chines
Experimental Group:(1)Diabetes health education, low-sodium and low-fat diet, high-quality low-protein diet, protein intake of 0.8 g/kg/day, dietary sodium intake <2 g/day
psychological counseling for patients to actively cooperate with the current treatment.(2)Basic drug therapy: If blood glucose control is unsatisfactory, according to the recommendations of the "Chine

Sponsors

Integrated Chinese and Western Medicine Hospital, Cangzhou, Province of Hebei
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria for type 2 diabetes mellitus; (2) Meets diagnostic criteria for diabetic kidney disease stage A2; (3) Traditional Chinese medicine (TCM) differential diagnosis: deficiency of both qi and yin (with blood stasis); (4) HbA1c = 8.5%; (5) eGFR = 60 mL/min/1.73m²; (6) Aged 18 to 75 years, gender unrestricted; (7) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiovascular, cerebrovascular, liver, or hematopoietic system diseases; (2) Serum potassium =4.8 mmol/L; (3) Patients on triple antihypertensive therapy with systolic blood pressure =160 mmHg; (4) Pregnant or breastfeeding women; (5) Kidney diseases caused by other reasons; (6) Individuals allergic to the study drug; (7) Individuals who have participated in or are currently participating in clinical trials of other drugs, or are receiving hormonal drugs or immunosuppressive therapy within the past three months.

Design outcomes

Primary

MeasureTime frame
Urinary Albumin-Creatinine Ratio;Glomerular filtration rate;Serum Creatinine;Urea nitrogen;TCM Syndrome Score;—

Secondary

MeasureTime frame
Fasting Blood Glucose;glycated hemoglobin;Cholesterol;Triglyceride;Low-density lipoprotein cholesterol;—

Countries

China

Contacts

Public ContactLü Shuquan

Integrated Chinese and Western Medicine Hospital, Cangzhou, Province of Hebei

czlvshuquan@163.com18031783391

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Oct 17, 2026