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Evidence-based evaluation of Qidan Tangshen granule in the treatment of early diabetic kidney diease

Randomized double-blind study of Qidan Tangshen granule on early diabetic kidney diease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056016
Enrollment
Unknown
Registered
2022-01-30
Start date
2020-12-01
Completion date
Unknown
Last updated
2024-08-05

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

Experimental group:Qidan Tangshen granule, Valsartan simulator
Control group:Qidan Tangshen granule simulator, Valsartan

Sponsors

LongHua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of diabetic kidney disease; 2.Type 2 diabetes; 3.Voluntarily participate in the clinical trial, give informed consent and sign informed consent; 4.TCM syndrome differentiation of qi deficiency and blood stasis; 5.Aged between 18 and 75 (including 18 and 75), with no gender limitation; 6.90/60 mmHg <= blood pressure <= 140/90 mmHg, and ACEI and ARB antihypertensive drugs are not used in the antihypertensive scheme; 7.Fasting blood glucose < 7.8 mmol/L, random blood glucose < 16.9 mmol/L, glycated hemoglobin < 9%, and SGLT2 and GLP-1 hypoglycemic drugs are not used in the hypoglycemic scheme.

Exclusion criteria

Exclusion criteria: 1.All kinds of primary kidney disease or secondary kidney disease except diabetic kidney disease; 2.At baseline, ALT or AST >= 1.5 times the upper limit of normal reference value, or hemoglobin <= 90 g/L; 3.Patients with acute infectious diseases, active and delayed stage of chronic viral hepatitis B, decompensated stage of cirrhosis and active stage tuberculosis, heart failure, cardiovascular accidents, trauma, surgery, urinary tract obstruction, renal artery stenosis, renal congenital malformation, after nephrectomy, etc.; 4.Patients who have used systemic sex hormones, immunosuppressants or renal replacement therapy in the past 3 months or currently need these treatment; 5.Allergic constitution, pregnant or lactating women; 6.Patients enrolled in other clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate;Urinary albumin/creatinine;TCM syndromes and tongue and pulse;

Secondary

MeasureTime frame
Glycosylated hemoglobin;Fasting plasma glucose;Blood glucose 2 hours after meal;

Countries

China

Contacts

Public ContactHua Yang

LongHua Hospital Shanghai University of Traditional Chinese Medicine

yanghua@longhua.net+86 13916107306

Outcome results

None listed

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