Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy

Phase 2

Recruiting

Conditions: diabetic nephropathy.
Type 2 diabetes mellitus with diabetic nephropathy
E11.21

Registration Number: IRCT20190810044500N4

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

age 18 years or older
A history of type 2 diabetes for at least 5 years, as defined by the WHO
fasting urine albumin/creatinine ratio of 30 mg/g or higher on two separate occasions within the past 3 months
HbA1C less than 8
blood pressure less than 160/100
Serum creatinine levels less than or equal to 2 mg/dL
treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin
treatment of hypercholesterolemia with(but not limited to) a statin

Exclusion Criteria

GFR less than 30 mL/min/1.73 m2
chronic heartfailure with New York Heart Association class III or IV
alcohol dependency or cigarette smoking
use of one of certain specified medications within 3 months prior to enrollment in the study (nonsteroidal anti-inflammatory agents and antioxidant supplements, including vitamin E, vitamin C, fish oil extracts [omega-3 fatty acids], green tea preparations, pomegranate extracts, and grape extracts
Recent stroke, active cancer, anemia
recurrent urinary tract infection
pregnancy and lactation
Drug intolerance
Serious medical conditions in which the patient is unable to attend regular visits include severe cardiovascular disease such as angina or heart attack.
Mental conditions that prevent conscious consent to enter the study or follow the study protocol

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood sugar levels. Timepoint: Before and after intervention. Method of measurement: blood sample.;Glycosylated hemoglobin. Timepoint: Before and after intervention. Method of measurement: blood sample.;, Blood urea nitrogen (BUN). Timepoint: Before and after intervention. Method of measurement: blood sample.;Serum creatinine. Timepoint: Before and after intervention. Method of measurement: blood sample.;24-hour urinary protein. Timepoint: Before and after intervention. Method of measurement: blood sample.;Urinary albumin-creatinine ratio (UACR),. Timepoint: Before and after intervention. Method of measurement: blood sample.;Blood levels of TGF-ß. Timepoint: Before and after intervention. Method of measurement: blood sample.

Secondary Outcome Measures

Name	Time	Method
ife quality. Timepoint: Before and after intervention. Method of measurement: questionnaire.;Adverse effects. Timepoint: Before and after intervention. Method of measurement: questionnaire.