Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001796
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
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, low-sodium and low-fat diet, high-quality low-protein diet, protein intake of 0.8 g/kg-1·d-1, dietary sodium intake <2g/d
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 "Chin
Experimental Group:(1)Diabetes health education, low-sodium and low-fat diet, high-quality low-protein diet, protein intake of 0.8 g/kg-1·d-1, dietary sodium intake <2g/d

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 (DKD) Stage A2; (3) Chinese medical pattern identification: Qi and Yin deficiency (with blood stasis) syndrome; (4) HbA1c = 8.5%; (5) eGFR = 60mL/min/1.73 m²; (6) Age 18–75 years, gender; (7) Signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiovascular, cerebrovascular, hepatic, or hematopoietic system diseases; (2) Patients on triple antihypertensive therapy with systolic blood pressure =160 mmHg; (3) Pregnant or breastfeeding women; (4) Patients with nephropathy caused by other reasons; (5) Patients allergic to the study drug; (6) Patients who have participated in or are currently participating in other drug clinical trials within the past three months, or are receiving hormonal or immunosuppressive therapy; (7) Patients who have used SGLT2i drugs within the past three months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Urine Microalbumin/Urine Creatinine;—

Secondary

MeasureTime frame
Glomerular filtration rate,eGFR;TCM Syndrome Score;—

Countries

China

Contacts

Public ContactLü Shuquan

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

czlvshuquan@163.com18031783392

Outcome results

None listed

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