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Efficacy and safety of Keluoxin capsule combined with SGLT2 inhibitor in the treatment of diabetic nephropathy

Efficacy and safety of Keluoxin capsule combined with SGLT2 inhibitor in the treatment of diabetic nephropathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000586
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Type 2 diabetic nephropathy

Interventions

Keluoxin Capsule treatment group:Take Keloxin Capsules
SGLT2i combined with Keloxin capsule treatment group:Taking Keloxin capsules and SGLT2i drugs with evidence of renal protection
SGLT2i treatment group:Taking SGLT2i drugs empagliflozin tablets or dapagliflozin tablets with evidence of renal protection

Sponsors

Armed Police Hospital of Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have been diagnosed with T2DM according to the 1999 WHO diagnostic criteria; 2. Patients with diabetic nephropathy diagnosed according to the diagnostic criteria recommended in the 2021 "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease"; that is, UACR=30 mg/g at least twice within 3 months, excluding interfering factors; 3. The estimated glomerular filtration rate (eGFR) is between 30 and 90mL/min/1.73m2. 4. According to the syndrome differentiation and classification standards for the treatment of diabetes in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine (Trial)" and the diagnostic standards for blood stasis syndrome formulated by the Chinese Society of Integrated Traditional Chinese and Western Medicine, those who meet the syndrome of deficiency of both qi and yin and blood stasis; 5. Have received stable maximum tolerated doses of ACEi/ARB for =4 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients with non-deficiency of both qi and yin combined with blood stasis syndrome or patients with nephropathy caused by other types of diabetes; 2. Pregnant and nursing women; 3. Acute complications of severe diabetes; 4. Patients with severe liver dysfunction; 5. Acute attack period of severe cardiovascular and cerebrovascular diseases; 6. Have used or are using other proprietary Chinese medicines with renal-protecting effects SGLT2i drugs and other drugs that have an impact on renal function within the previous 3 months; 7. In the opinion of the investigator there are any other circumstances that may prevent the subject from completing the study or pose significant risks to the subject.

Design outcomes

Primary

MeasureTime frame
TCM symptom points;Kidney disease progression rate;Delayed or reversed kidney disease rate;Effective treatment of kidney disease;

Secondary

MeasureTime frame
islet function;waist height ratio;body mass index;blood glucose;blood lipid;serum uric acid;weight;waist-hip ratio;blood pressure;

Countries

China

Contacts

Public ContactYin Jingxia

Armed Police Hospital of Chongqing

906802276@qq.com13527349863

Outcome results

None listed

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