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Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625442
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Birjand University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome Hypercholesterolemia Hypertriglyceridemia Hyperglycemia Drug: Saffron tablet Drug: Barberry tablet Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Birjand University of Medical Sciences:

Primary Outcome Measures:
  • Serum LDL cholesterol [ Time Frame: after 45 days of treatment ]
    Serum LDL cholesterol after 45 days of treatment in three study groups


Secondary Outcome Measures:
  • Serum total cholesterol [ Time Frame: after 45 days of treatment ]
    Serum total cholesterol after 45 days of treatment in three study groups

  • serum HDL cholesterol [ Time Frame: after 45 days of treatment ]
    serum HDL cholesterol after 45 days of treatment in three study groups

  • serum triglyceride [ Time Frame: after 45 days of treatment ]
    serum triglyceride after 45 days of treatment in three study groups

  • Fasting Blood Sugar [ Time Frame: after 45 days of treatment ]
    Fasting Blood Sugar after 45 days of treatment in three study groups

  • Hematocrit [ Time Frame: after 45 days of treatment ]
    Hematocrit measured after 45 days of treatment


Enrollment: 732
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saffron
Saffron treatment group received saffron tablets daily for 45 days
Drug: Saffron tablet
Saffron tablets 100 mg
Other Name: crocin
Active Comparator: Barberry
Barberry group received barberry tablets daily for 45 days
Drug: Barberry tablet
Barberry tablets 200 mg
Placebo Comparator: Placebo
Placebo group received placebo tablets daily for 45 days
Drug: Placebo
Placebo tablets received daily for 45 days

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following:
  • blood pressure ≥ 130/85 or taking antihypertensive medication,
  • fasting plasma glucose (FPG) > 100 mg/dL,
  • serum triglycerides (TG) > 150 mg/dL,
  • high-density lipoprotein (HDL) < 40 mg/dL in men,and < 50 mg/dL in women-

Exclusion Criteria:

  • using insulin or glucose sensitizing medication
  • preexisting cardiovascular disease
  • psychiatric problems
  • non-compliance of patients
  • not presenting at times determined for treatment and evaluation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625442


Locations
Iran, Islamic Republic of
Birjand University of medical sciences
Birjand, South khorasan, Iran, Islamic Republic of, 9714815395
Sponsors and Collaborators
Birjand University of Medical Sciences
Investigators
Principal Investigator: Tayyebeh Kermani, Ph.D. Assistant proffessor of anatomy
Study Director: Maryam Navabzadeh, M.D. Traditional iranian medicine specialist
Principal Investigator: Gholamreza Sharifzadeh, M.S. Biostatistician
Principal Investigator: Javad Hadinia, B.S. Traditional iranian medicine practitioner
Principal Investigator: Narges Saffari, B.S. Health technician
Study Chair: Mohammad Khodashenas Roudsari, M.D. Assistant proffessor of internal medicine
  More Information

Responsible Party: Birjand University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01625442     History of Changes
Other Study ID Numbers: 3132012
3132012n ( Other Identifier: birjand university of medical sciences )
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Birjand University of Medical Sciences:
Metabolic syndrome
hypercholesterolemia
hypertriglyceridemia
hyperglycemia

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Hypercholesterolemia
Hyperglycemia
Hypertriglyceridemia
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders