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The Effect of Tangshen Formula on Patients with Type 2 diabetic Kidney Disease of both Qi and Yin deficiency syndrone: a Multicentre Randomized Placebo-Controlled Trial

Systems biological research of Traditional Chinese Medicine for prevention and treatment of chronic renal failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000843
Enrollment
Unknown
Registered
2010-04-15
Start date
2007-06-01
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 nephropathy

Interventions

control group:basic treatment of western medicine plus placebo
treatment group:basic treatment of western medicine plus Tangshen Formula

Sponsors

China-Japan Friendship hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with TCM diagnostic criterion of diabetes and syndrome differentiation criterion of Qi and Yin deficiency with blood stasis; 2. Consistent with WHO diagnostic criterion of diabetes: (1) type 2 diabetes; (2) fasting blood glucose level20ug/min; (5) glomerular filtration rate 60-130ml/min; 24 hour urinary protein<2.0g; (6) (4) and/or (5) 3. Systolic blood pressure<140mmHg, diastolic blood pressure<90mmHg, taking or not taking hypotensive drugs; 4. those who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those that do not consistent with the diagnostic criteria of diabetes in TCM; 2. With Fasting blood glucose (FBG) >7.8mmol/L or HbA1c>7.5%; 3. With myocardial infarction history, current vagina pectoris or other vascular event more than once; 4. With recent cardiovascular event; 5. With retinopathy requiring laser treatment; 6. With secondary hypertension; 7. Complicated with cerebrovascular disease, primary kidney disease, other diseases with positive urinary protein, blood disease, enuropathies except for diabetic periphery neuropathy, other endocrine and metabolic disease and mental disorder; 8. Fasting serum TG>10 mmol/L(>886mg/dl) and transaminase elevated over 2 above the upper limit normal; 9. Received drugs such as cortisone, beta-blocker, thiazole diauretics and nicacid within 3 months; 10. Recent infection within 4 weeks; 11. Women in pregnancy or lactation and those who are allergic with the herbal medicine; 12. Those who do not coordinate, i.e. those who do not take dietary management or drugs as ordered; 13. Those who do not fully understand this research procedure or do not consent to participate or those who are with poor compliance.

Design outcomes

Primary

MeasureTime frame
Urinary albumine excretion rate (UAER) and 24-hour;

Secondary

MeasureTime frame
renal function parameters serum creatinine blood urinary nitrogen and estimated glomerular filtration;blood lipid profiler;

Countries

China

Contacts

Public ContactPing Li
lp8675@yahoo.com.cn+86 010 64227163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026