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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birjand University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01625442
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012

June 19, 2012
June 20, 2012
January 2010
July 2011   (final data collection date for primary outcome measure)
Serum LDL cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
Serum LDL cholesterol after 45 days of treatment in three study groups
Same as current
Complete list of historical versions of study NCT01625442 on ClinicalTrials.gov Archive Site
  • Serum total cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
    Serum total cholesterol after 45 days of treatment in three study groups
  • serum HDL cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
    serum HDL cholesterol after 45 days of treatment in three study groups
  • serum triglyceride [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
    serum triglyceride after 45 days of treatment in three study groups
  • Fasting Blood Sugar [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
    Fasting Blood Sugar after 45 days of treatment in three study groups
  • Hematocrit [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]
    Hematocrit measured after 45 days of treatment
Same as current
Not Provided
Not Provided
 
Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome
Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Hypercholesterolemia
  • Hypertriglyceridemia
  • Hyperglycemia
  • Drug: Saffron tablet
    Saffron tablets 100 mg
    Other Name: crocin
  • Drug: Barberry tablet
    Barberry tablets 200 mg
  • Drug: Placebo
    Placebo tablets received daily for 45 days
  • Active Comparator: Saffron
    Saffron treatment group received saffron tablets daily for 45 days
    Intervention: Drug: Saffron tablet
  • Active Comparator: Barberry
    Barberry group received barberry tablets daily for 45 days
    Intervention: Drug: Barberry tablet
  • Placebo Comparator: Placebo
    Placebo group received placebo tablets daily for 45 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
732
February 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01625442
3132012, 3132012n
Yes
Birjand University of Medical Sciences
Birjand University of Medical Sciences
Not Provided
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
Birjand University of Medical Sciences
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP