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A randomized partially double-blind controlled multicenter clinical study of Gegen Qinlian Modified granules combined with irbesartan in the treatment of damp-heat type 2 diabetic nephropathy

A randomized partially double-blind controlled multicenter clinical study of Gegen Qinlian Modified granules combined with irbesartan in the treatment of damp-heat type 2 diabetic nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000601
Enrollment
Unknown
Registered
2024-10-23
Start date
2024-10-25
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

diabetic kidney disease(DKD)

Interventions

GQ decoction group (group D):Lifestyle interventions+Irbesartan(Basic treatment)+GQ decoction
Conventional dose GQ formula granule group (group M):Lifestyle interventions+Irbesartan(Basic treatment)+Conventional dose GQ formula granule
GQ formula granule simulator group (group P):Lifestyle interventions+Irbesartan(Basic treatment)+GQ formula granule simulator
Low-dose GQ formula granule group (group L):Lifestyle interventions+Irbesartan(Basic treatment)+Low-dose GQ formula

Sponsors

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the western medical diagnostic criteria for diabetic nephropathy. (2) Aged between 18 and 70 years old regardless of gender. (3) Blood pressure = 160/95 mmHg. (4) Fasting blood glucose (FPG) = 14 mmol/L and glycosylated hemoglobin (HbA1c) = 8%. (5) Creatinine clearance rate is 30 - 59 ml/min or 24-hour urine protein quantification (24hUPro) is 0.15 - 3.49 g/24h. (6) Signing the informed consent form voluntarily participating in the trial and being able to take medicine and undergo examinations as agreed.

Exclusion criteria

Exclusion criteria: (1) Those with other types of diabetes except type 2 diabetes and those who have had acute complications such as diabetic ketoacidosis and hyperglycemic hyperosmolar coma recently. (2) Pregnant or lactating women. (3) Those with proteinuria caused by other diseases such as chronic glomerulonephritis IgA nephropathy and membranous nephropathy. (4) Those with malignant tumors severe infections those with cardiac and pulmonary insufficiency and those who have received hemodialysis and after kidney transplantation. (5) Those with abnormal liver function more than three times higher than the normal value. (6) Patients with a history of alcohol and drug abuse and those with mental disorders. (7) Those with contraindications to drug use or allergic to drugs. (8) Those who have had obvious renal function damage caused by daily oral drugs. (9) Those who have used ACEI and ARB drugs within nearly 4 weeks. (10) Those who have started using SGLT2i GLP-1RA and MRA drugs within nearly 4 weeks. (11) Those who participate in other clinical trials during the treatment period.

Design outcomes

Primary

MeasureTime frame
mALb;24hUPro;UACR;DKD staging and grading assessment form;

Secondary

MeasureTime frame
IMT;HbA1c;AI;DKD symptom score form;Fundus examination;HDL;TG;Cr;BUN;TC;2hPBG;Traditional Chinese medicine syndrome score form for DKD;FBG;LDL-C;eGFR;CysC;

Countries

China

Contacts

Public ContactXIAOFENG GU

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Wxszyyy@163.com0510-85108060

Outcome results

None listed

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