Type 2 Diabetes. Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Intervention 1: Group I (intervention group): Prescription 15 mg of saffron capsules once every 12 hours and twice in one day for 3 month. Each capsule contains 15 milligrams of dried extract of saffr
Treatment - Drugs
Placebo
Group I (intervention group): Prescription 15 mg of saffron capsules once every 12 hours and twice in one day for 3 month. Each capsule contains 15 milligrams of dried extract of saffron, lactose, mag
Group II (control group): Prescription 15 mg of placebo capsule once every 12 hours and twice in one day for 3 month. Each capsule contains lactose, magnesium stearate and sodium starch glycolate.
Sponsors
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients with type 2 diabetes; Patients with ages: 30-55 years old; FBS levels between 126-200 milligrams per deciliter; HbA1c levels between 7% -8.5%. Exclusion Criteria: Using insulin; Hyperthyroidism; Hypothyroidism; Allergy to saffron; Chronic complications of diabetes such as neuropathy and retinopathy; Smoking; Alcohol and drug abuse; Anticoagulant drugs such as macroalbuminuria in diabetic nephropathy; Renal failure; Pregnant and lactating women.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;Hemoglobin A1c (HbA1c) levels. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;The serum levels of triglycerides, LDL, HDL, Total cholesterol. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;Fasting insulin levels. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;Serum total antioxidants capacity. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;The inflammatory markers. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;Body mass index (BMI). Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: By Using the formula: weight (kg) / the square of the height (m).;Insulin resistance. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: By Using the homeostasis model Assessment-insulin resistance (HOMA-ir) formula: fasting blood glucose (mmol/L) × fasting insulin (µU/ml)/22.5.;BUN/CR levels. Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory.;Liver enzyme levels (AST, ALT, ALK). Timepoint: Before intervention and after completion of intervention in the twelfth week. Method of measurement: Venous sampling and sent to the laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum total cholesterol. Timepoint: before intervention and three months after intervention. Method of measurement: Laboratory kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArmaghan Moravej Aleali
Ahvaz Jundishapur University of Medical Sciences
Outcome results
None listed