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

Primary Purpose

Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Saffron tablet
Barberry tablet
Placebo
Sponsored by
Birjand University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birjand University of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Saffron

Barberry

Placebo

Arm Description

Saffron treatment group received saffron tablets daily for 45 days

Barberry group received barberry tablets daily for 45 days

Placebo group received placebo tablets daily for 45 days

Outcomes

Primary Outcome Measures

Serum LDL cholesterol
Serum LDL cholesterol after 45 days of treatment in three study groups

Secondary Outcome Measures

Serum total cholesterol
Serum total cholesterol after 45 days of treatment in three study groups
serum HDL cholesterol
serum HDL cholesterol after 45 days of treatment in three study groups
serum triglyceride
serum triglyceride after 45 days of treatment in three study groups
Fasting Blood Sugar
Fasting Blood Sugar after 45 days of treatment in three study groups
Hematocrit
Hematocrit measured after 45 days of treatment

Full Information

First Posted
June 19, 2012
Last Updated
June 20, 2012
Sponsor
Birjand University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01625442
Brief Title
Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome
Official Title
Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birjand University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Hyperglycemia
Keywords
Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saffron
Arm Type
Active Comparator
Arm Description
Saffron treatment group received saffron tablets daily for 45 days
Arm Title
Barberry
Arm Type
Active Comparator
Arm Description
Barberry group received barberry tablets daily for 45 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group received placebo tablets daily for 45 days
Intervention Type
Drug
Intervention Name(s)
Saffron tablet
Other Intervention Name(s)
crocin
Intervention Description
Saffron tablets 100 mg
Intervention Type
Drug
Intervention Name(s)
Barberry tablet
Intervention Description
Barberry tablets 200 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets received daily for 45 days
Primary Outcome Measure Information:
Title
Serum LDL cholesterol
Description
Serum LDL cholesterol after 45 days of treatment in three study groups
Time Frame
after 45 days of treatment
Secondary Outcome Measure Information:
Title
Serum total cholesterol
Description
Serum total cholesterol after 45 days of treatment in three study groups
Time Frame
after 45 days of treatment
Title
serum HDL cholesterol
Description
serum HDL cholesterol after 45 days of treatment in three study groups
Time Frame
after 45 days of treatment
Title
serum triglyceride
Description
serum triglyceride after 45 days of treatment in three study groups
Time Frame
after 45 days of treatment
Title
Fasting Blood Sugar
Description
Fasting Blood Sugar after 45 days of treatment in three study groups
Time Frame
after 45 days of treatment
Title
Hematocrit
Description
Hematocrit measured after 45 days of treatment
Time Frame
after 45 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tayyebeh Kermani, Ph.D.
Organizational Affiliation
Assistant proffessor of anatomy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maryam Navabzadeh, M.D.
Organizational Affiliation
Traditional iranian medicine specialist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gholamreza Sharifzadeh, M.S.
Organizational Affiliation
Biostatistician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javad Hadinia, B.S.
Organizational Affiliation
Traditional iranian medicine practitioner
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narges Saffari, B.S.
Organizational Affiliation
Health technician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Khodashenas Roudsari, M.D.
Organizational Affiliation
Assistant proffessor of internal medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Birjand University of medical sciences
City
Birjand
State/Province
South khorasan
ZIP/Postal Code
9714815395
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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