Randomized, double-blind (patients and researchers), placebo-controlled, single-center, third phase of clinical trial
Main purpose is to evaluate the effect of Nigella Sativa on metabolic markers in post-menopausal women and the practical purpose is to find an effective treatment for post-menopausal women with metabolic disorders. The sample size is 70 and using randomizing blocks of two alleles, people randomly divided into two groups. Intervention in cases, including administration of Nigella Sativa at a daily dose of 500 milligrams (in addition to exercise and diet) and in control group is prescribing a placebo along with exercise and diet.
Inclusion criteria consist of metabolic syndrome measures (such as abdominal obesity, high triglyceride levels, high density cholesterol level, systolic and diastolic blood pressure and fasting blood glucose level) as well as the level of total cholesterol and low density cholesterol. Moreover, these persons must have signed informed consent.
Exclusion criteria include items interfere with study outcomes or prescribing drugs. Its examples include pregnancy, diabetes, gouty arthritis, blood pressure more than Stage 1, acute or chronic coronary artery disease and a history of cardiovascular events.
Sample size: 70
Study time: 3 months
Primary outcome variables:
Fasting blood glucose, total cholesterol level, high density cholesterol level, low density cholesterol level, triglyceride level
Secondary outcome variables:
Blood cell count, C-reactive protein, headache, back pain, nausea, vomiting, vaginal itching, vaginal atrophy, sexual dysfunction, vaginal dryness, drowsiness, surgical history, medication, occupation, flushing, waist, weight, parity, age, skin changes, breast pain