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
Among 11 studies in Metabolic Syndrome with a site in Iran, Islamic Republic of — none open to participants now, none under way, none of them phase 3. Metabolic Syndrome · Iran, Islamic Republic of.
Among the 11 studies in Metabolic Syndrome with a site in Iran, Islamic Republic of, this one has the largest enrollment of the 10 interventional ones that give a count, is the only one that started in 2010, is the only one in phase 4, and was the 1st registered.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
Browse Metabolic Syndrome studies →None of the 11 studies in Metabolic Syndrome with a site in Iran, Islamic Republic of is open now.
Of the 232 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 136 (59%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2010.
This study's enrollment of 732 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Median enrollment 47 across the 10 interventional studies, 10,000 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 6 most frequent:
Birjand University of Medical Sciences is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Birjand University of Medical Sciences has 1 study filed under Metabolic Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Metabolic Syndrome with a site in Iran, Islamic Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
How these figures are worked out, and which studies are left out of them.
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