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Effect of crocin supplementation in patients with diabetic nephropathy

The effect of crocin supplementation on glycemic control, inflammatory factors, oxidative stress biomarkers, glomerular and tubular markers in patients with diabetic nephropathy: A randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170611034458N3
Enrollment
60
Registered
2024-07-20
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Diabetic nephropathy. Diabetes mellitus due to underlying condition with diabetic nephropathy

Interventions

Intervention 1: The intervention group will receive crocin supplement (produced by Sami Saz Company) for 12 weeks. Each tablets contains 30 mg of crocin. The tablets will be provided to the patients i

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with diabetic nephropathy aged 40 to 75 years Moderate blood pressure (systolic pressure 140-160 and diastolic pressure 90-100 mm Hg) Absence of urinary tract infection and any other disease that can cause proteinuria Glomerular filtration rate more than 60 milliliters per minute.

Exclusion criteria

Exclusion criteria: Taking antioxidant supplements from three months before entering the study. Patients who do not want to participate in the study or do not take medication regularly. Taking steroidal immunosuppressive drugs (corticosteroids). Suffering from certain cardiovascular diseases, cancer, inflammatory diseases, autoimmune disorders, or hyper- or hypothyroidism. Taking anticoagulants. Having high blood pressure (systolic pressure above 140 and diastolic pressure above 90 mm Hg). pregnancy Smoking and alcohol use

Design outcomes

Primary

MeasureTime frame
Serum Creatinine. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Blood Urea Nitrogen. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.

Secondary

MeasureTime frame
Fasting blood sugar. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Serum concentrations of insulin. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Homeostatic model assessment for Insulin Resistance Index (HOMA-IR). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: The HOMA-IR Index is calculated using fasting glucose and fasting insulin levels.;Serum concentrations of triglyceride. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;HDL-C cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Total cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;LDL cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Evaluation of the serum level of Cystatin-C parameter. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Nitric oxide. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Serum concentrations of high sensitivity c-reactive protein (hs-CRP). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Serum concentrations of Interleukin 6 (IL-6). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Serum concentration of Total antioxid

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Mokhtari

Esfahan University of Medical Sciences

zeinab_mokhtary@yahoo.com+98 31 3792 3183

Outcome results

None listed

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