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

Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy: A randomized triple-blind placebo-controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190810044500N4
Enrollment
44
Registered
2020-04-25
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

diabetic nephropathy. Type 2 diabetes mellitus with diabetic nephropathy

Interventions

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Life quality. Timepoint: Before and after intervention. Method of measurement: questionnaire.;Adverse effects. Timepoint: Before and after intervention. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactbehzad kafami

Yazd University of Medical Sciences

behzadk74@gmail.com+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026