Black seeds (Nigella Sativa) effect on Diabetes Mellitus

Phase 2

Conditions: Health Condition 1: null- unconrolled type 2 diabetic patients

Registration Number: CTRI/2013/06/003781

Lead Sponsor: niversity of Dammam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Applicable

Sex: Not specified

Target Recruitment: 114

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Glycosylated hemoglobin( HbA1c) <br/ ><br>-Fasting C-peptide. <br/ ><br>-Lipid profile: triglycerides, total cholesterol (Total-c), low density lipoprotein cholesterol (LDL-c) and high density lipoprotein cholesterol (HDL-c). <br/ ><br>-Serum antioxidants: antioxidant enzymes: superoxide dismutase, catalase, total antioxidant activity, glutathione and thiobarbituric acid reactive species [TBARS]. <br/ ><br>-Arterial blood pressure and pulse. <br/ ><br>-Electrocardiography (ECG). <br/ ><br>-Echocardiography. <br/ ><br>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) <br/ ><br>

Secondary Outcome Measures