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Effects and safety of Tangshen Formula on Patients with Type 2 Diabetic Kidney Disease: A Multicenter Double-Blinded Randomized Placebo-Controlled Tria

Research and Development of Innovative Herb Medicine for Treatment of Diabetic Kidney Disease by Taking Advantage of Novel Statistical Methods

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003566
Enrollment
Unknown
Registered
2013-08-09
Start date
2013-09-16
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

diabetic kidney disease

Interventions

treatment group:conventional treatment of western medicine plus tangshenfang
placebo group:conventional treatment of western medicine plus placebo

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) DKD diagnostic criteria;a) type 2 diabetes;b) Diabetic retinopathy; (2) 24h urinary protein (24-h UP) level between 0.5 and 3.5 gram; (3) serum creatinine <265umol/L(3mg/dl); (4) with hypertension (blood pressure can be controlled <=130 / 80mmHg by anti-hypertension agents) or without hypertension; (5) HbA1c <=7.5%; (6) Chinese syndrome differentiation type as Qi and Yin deficiency and blood stasis; (7) Taking Irbesartan continuously for 2 weeks, 300mg daily; (8) aged between 18 and 70 years old; (9) signed informed consent.

Exclusion criteria

Exclusion criteria: (1) blood pressure 5.5mmol/L or <3.5mmol/L; (3) doubling of serum creatinine within half a year; (4) renal artery stenosis; (5) other server diabetic complications or serious macrovascular events within half a year. For example, cerebral hemorrhage, massive cerebral infarction and Acute myocardial infarction; (6) recent infection within 4 weeks; (7) other primary or secondary renal disease; (8) other server diseases, malignant tumor; (9) server mental disorders; (10) pregnant or lactating women; (11) allergic to component of agents in this study; (12) Involved in other clinical trials.

Design outcomes

Primary

MeasureTime frame
24 hours urinary protein;high-sensitivity C-reactive protein;

Secondary

MeasureTime frame
serum creatinine;estimated glomerular filtration rate;traditional Chines medicine scores;triglyceride;total cholesterol;low density lipoprotein;high-density lipoprotein;

Countries

China

Contacts

Public ContactPing Li

China-Japan Friendship Hospital

lp8675@163.com+86 13601246013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026