IRCT20190810044500N4
Recruiting
Phase 2
Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy: A randomized triple-blind placebo-controlled trial
Yazd University of Medical Sciences0 sites44 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- diabetic nephropathy.
- Sponsor
- Yazd University of Medical Sciences
- Enrollment
- 44
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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