Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial.
Trials
; 19(1): 200, 2018 Mar 27.
Article
en En
| MEDLINE
| ID: mdl-29587863
ABSTRACT
BACKGROUND:
Diabetic kidney disease (DKD) is a serious complication associated with diabetes mellitus and can cause end-stage renal disease (ESRD). Traditional Chinese medicine (TCM) is widely used in China to treat DKD, and in particular microalbuminuria and macroalbuminuria. This study will address the efficacy and safety of Shenzhuo Formula (SZF), a frequently prescribed TCM, in DKD patients with macroalbuminuria. METHODS/DESIGN:
This study is a 24-week, randomized, multi-center, double-blinded, double-dummy, controlled, clinical trial that will include 120 DKD patients aged 18 to 80 years old with a 24-h urinary protein (24-h UP) level of between 0.5 g and 3 g and serum creatinine (SCr) ≤ 133 µmol/L (1.5 mg/dL) and compare SZF to irbesartan. The 24-h UP change from baseline to week 24 will represent the primary endpoint with secondary endpoints including SCr, estimated glomerular filtration rate (eGFR), TCM symptoms, urinary albumin excretion rate (UAER), etc. Safety assessments will also be evaluated.DISCUSSION:
This study will provide initial evidence regarding the efficacy and safety of SZF relative to irbesartan in the treatment of DKD patients with macroalbuminuria. TRIAL REGISTRATION Chinese Clinical Trial Registry, ID ChiCTR-ICR-15006311 . Registered on 15 April 2015.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Medicamentos Herbarios Chinos
/
Bloqueadores del Receptor Tipo 1 de Angiotensina II
/
Nefropatías Diabéticas
/
Albuminuria
/
Irbesartán
/
Riñón
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2018
Tipo del documento:
Article
País de afiliación:
China