A Phase 4 interventional study of Saffron tablet and Barberry tablet in Metabolic Syndrome, Hypercholesterolemia and Hypertriglyceridemia, sponsored by Birjand University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-21.
Sponsored by Birjand University of Medical Sciences · Phase 4, Interventional, and Treatment
The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.
In a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet.
The aim was to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD) and diabetes mellitus (DM). The major features of the metabolic syndrome include central obesity hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension. Based on data from the National Health and Nutrition Examination Survey (NHANES) III, the age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for Women. Review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. Barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 732 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Birjand University of Medical Sciences is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Saffron treatment group received saffron tablets daily for 45 days
Drug: Saffron tablet
Barberry group received barberry tablets daily for 45 days
Drug: Barberry tablet
Placebo group received placebo tablets daily for 45 days
Drug: Placebo
Saffron tablets 100 mg
Also known as: crocin
Barberry tablets 200 mg
Placebo tablets received daily for 45 days
Serum LDL cholesterol
Serum LDL cholesterol after 45 days of treatment in three study groups
Time frame: after 45 days of treatment
Serum total cholesterol
Serum total cholesterol after 45 days of treatment in three study groups
Time frame: after 45 days of treatment
serum HDL cholesterol
serum HDL cholesterol after 45 days of treatment in three study groups
Time frame: after 45 days of treatment
serum triglyceride
serum triglyceride after 45 days of treatment in three study groups
Time frame: after 45 days of treatment
Fasting Blood Sugar
Fasting Blood Sugar after 45 days of treatment in three study groups
Time frame: after 45 days of treatment
Hematocrit
Hematocrit measured after 45 days of treatment
Time frame: after 45 days of treatment
The record gives a start of Jan 2010, a primary completion of Jul 2011 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Saffron
Birjand University of Medical Sciences