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Effect of Saffron consumption in type 2 Diabetic Patients

Effect of Saffron consumption in comparison with placebo on Glycemic status, lipid profile, nephropathy, fat body percent and some blood biochemical parameters in type 2 Diabetic Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201510259472N9
Enrollment
90
Registered
2015-12-12
Start date
2015-11-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Type 2 diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention group: receiving one pill containing 100 mg powder of Saffron daily with meal for 3 months. Intervention 2: Control group: receiving one pill containing 100 mg maltode
Treatment - Drugs
Placebo
Intervention group: receiving one pill containing 100 mg powder of Saffron daily with meal for 3 months.
Control group: receiving one pill containing 100 mg maltodextrin daily with meal for 3 months.

Sponsors

Vice-chancellor for research Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with type 2 Diabetes; 30-70 years ages; diabetes patients with oral medication intake; not Smoking and Alcohol intake; Hb A1C: 7-10 % ; BMI between 20-35; no Pregnancy and Lactation; not consumption of antioxidants , multivitamins and omega 3 supplements from 3 months ago; do not taking the lipid and blood pressure- lowering drugs ; not consumption contraceptives and insulin therapy. Exclusion criteria: unwillingness to continue cooperation; taking less than 80% of supplements(the compliance lower than %80); changes in Diet or Physical activity; changes in type or dose of medication; renal, hepatic, thyroid and Parathyroid disorders.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
HbA1c. Timepoint: Before intervention and three months after intervention. Method of measurement: ELISA.;FBS. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic method.;Insulin. Timepoint: Before intervention and three months after intervention. Method of measurement: ELISA.;Total cholesterol. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic method.;Triglyceride. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic method.;LDL. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic method.;HDL. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic method.;Systolic blood pressure. Timepoint: Before intervention and three months after intervention. Method of measurement: Mercury sphygmomanometer.;Diastolic blood pressure. Timepoint: Before intervention and three months after intervention. Method of measurement: Mercury sphygmomanometer.;MDA(Malondialdehyde). Timepoint: Before intervention and three months after intervention. Method of measurement: Spectrophotometry method.;Hs-CRP. Timepoint: Before intervention and three months after intervention. Method of measurement: ELISA.;TNF-a. Timepoint: Before intervention and three months after intervention. Method of measurement: ELISA.;TAC(Total antioxidant capacity). Timepoint: Before intervention and three months after intervention. Method of measurement: Spectrophotometry method.;BMI(Body mass index). Timepoint: Before intervention and three months after intervention. Method of measurement: Weight (kg)/[height (m)]2, kg/m2.;Age. Timepoint: Before intervention. Method of measurement: questionnaire.;Weight. Timepoint: Before intervention and three months after intervention. Method of measurement: Scale.;Sex. Timepoint: Before intervention. Method of measurement: questionnaire.;Height

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nahid Aryaeian

Iran University of Medical Sciences

n-aryaeian@sina.tums.ac.ir+98 21 8877 9118

Outcome results

None listed

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