Health Condition 1: null- unconrolled type 2 diabetic patients
Conditions
Interventions
Intervention1: 2 grams/day of Nigella Sativa (black seeds) and oral hypoglycemic drugs: Nigella Sativa in the form of 500 mg capsules of whole grounded seeds supplied by BioExtract (Pvt) Ltd, Srilanka
Sponsors
University of Dammam
Eligibility
Inclusion criteria
Inclusion criteria: a) Those with uncontrolled type II diabetes (defined by two successive readings -three months apart- of hemoglobin A1c (HbA1c) of more than 7%. b) Aged between 18 and 60 years. c) On oral hypoglycemic drugs. d) Taking their medication regularly and ready for follow up.
Exclusion criteria
Exclusion criteria: a) Patients with HbA1c more than 9% (to avoid the necessity to change the drug regimen during the one year follow up of the patients, as levels 9% are less likely to cause complications within this period). b) Patients on insulin therapy. c) Body mass index (BMI)more than 40 (as BMI more than 40 is usually associated with morbid complications which make it difficult to keep the patients on same treatment for one year). d) Based on medical history using interview and medical files, patients with major cardiovascular problems. i.e. coronary artery disease, valvular diseases, heart failure, severe hypertension or nephropathy were excluded. e) The recruited patients were asked to sign a written consent prior to starting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Glycosylated hemoglobin( HbA1c) - Fasting C-peptide. - Lipid profile: triglycerides, total cholesterol (Total-c), low density lipoprotein cholesterol (LDL-c) and high density lipoprotein cholesterol (HDL-c). - Serum antioxidants: antioxidant enzymes: superoxide dismutase, catalase, total antioxidant activity, glutathione and thiobarbituric acid reactive species [TBARS]. - Arterial blood pressure and pulse. - Electrocardiography (ECG). - Echocardiography. Timepoint: ECG and Echocardiography were performed for each patient at three intervals; baseline and after six and 12 months on intervention. The other parameters were measured at five intervals; baseline and every three months thereafter (i.e. at 0, 3, 6, 9, and 12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| renal function tests liver function tests beta cell function insulin resistanceTimepoint: 3,6,9,12 months | — |
Countries
Saudi Arabia
Contacts
Public ContactAbdullah Bamosa
University of Dammam
Outcome results
None listed