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| ID | Type | Description | Link |
|---|---|---|---|
| 3132012n | Other Identifier | birjand university of medical sciences |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saffron | Active Comparator | Saffron treatment group received saffron tablets daily for 45 days |
|
| Barberry | Active Comparator | Barberry group received barberry tablets daily for 45 days |
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| Placebo | Placebo Comparator | Placebo group received placebo tablets daily for 45 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saffron tablet | Drug | Saffron tablets 100 mg |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Serum LDL cholesterol | Serum LDL cholesterol after 45 days of treatment in three study groups | after 45 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum total cholesterol | Serum total cholesterol after 45 days of treatment in three study groups | after 45 days of treatment |
| serum HDL cholesterol | serum HDL cholesterol after 45 days of treatment in three study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tayyebeh Kermani, Ph.D. | Assistant proffessor of anatomy | Principal Investigator |
| Maryam Navabzadeh, M.D. | Traditional iranian medicine specialist | Study Director |
| Gholamreza Sharifzadeh, M.S. | Biostatistician | Principal Investigator |
| Javad Hadinia, B.S. | Traditional iranian medicine practitioner | Principal Investigator |
| Narges Saffari, B.S. | Health technician | Principal Investigator |
| Mohammad Khodashenas Roudsari, M.D. | Assistant proffessor of internal medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birjand University of medical sciences | Birjand | South Khorasan Province | 9714815395 | Iran |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C029036 | crocin |
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| Barberry tablet | Drug | Barberry tablets 200 mg |
|
| Placebo | Drug | Placebo tablets received daily for 45 days |
|
| after 45 days of treatment |
| serum triglyceride | serum triglyceride after 45 days of treatment in three study groups | after 45 days of treatment |
| Fasting Blood Sugar | Fasting Blood Sugar after 45 days of treatment in three study groups | after 45 days of treatment |
| Hematocrit | Hematocrit measured after 45 days of treatment | after 45 days of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |