Metabolic SyndromePhase 4NCT01625442
Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome
A Phase 4 study testing Saffron tablet and Barberry tablet in people with Metabolic Syndrome and Hypercholesterolemia, run by Birjand University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- Saffron tablet and Barberry tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 732 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- using insulin or glucose sensitizing medication
- preexisting cardiovascular disease
- psychiatric problems
- non-compliance of patients
- not presenting at times determined for treatment and evaluation
Trial locations and contacts
1 site in 1 country.
Iran1 site
Birjand University of medical sciences
Birjand, South Khorasan Province, 9714815395
About this study
Official title: 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.
Read the 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.
- Being tested
- Saffron tablet, Barberry tablet, Placebo
- Keywords
- Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia
- Medical subject headings
- Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saffron tabletDrug
Also called crocin
Saffron tablets 100 mg
Barberry tabletDrug
Barberry tablets 200 mg
PlaceboDrug
Placebo tablets received daily for 45 days
| Study group | Role | What they receive |
|---|---|---|
| Saffron | Active comparator | Saffron treatment group received saffron tablets daily for 45 days Receives: Drug: Saffron tablet |
| Barberry | Active comparator | Barberry group received barberry tablets daily for 45 days Receives: Drug: Barberry tablet |
| Placebo | Placebo comparator | Placebo group received placebo tablets daily for 45 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum LDL cholesterol
Serum LDL cholesterol after 45 days of treatment in three study groups
Measured: after 45 days of treatment
Secondary outcomes (5)
Serum total cholesterol
Serum total cholesterol after 45 days of treatment in three study groups
Measured: after 45 days of treatment
serum HDL cholesterol
serum HDL cholesterol after 45 days of treatment in three study groups
Measured: after 45 days of treatment
serum triglyceride
serum triglyceride after 45 days of treatment in three study groups
Measured: after 45 days of treatment
Fasting Blood Sugar
Fasting Blood Sugar after 45 days of treatment in three study groups
Measured: after 45 days of treatment
Hematocrit
Hematocrit measured after 45 days of treatment
Measured: after 45 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birjand University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayyebeh Kermani, Ph.D., Principal investigator, Assistant proffessor of anatomyMaryam Navabzadeh, M.D., Study director, Traditional iranian medicine specialistGholamreza Sharifzadeh, M.S., Principal investigator, BiostatisticianJavad Hadinia, B.S., Principal investigator, Traditional iranian medicine practitionerNarges Saffari, B.S., Principal investigator, Health technicianMohammad Khodashenas Roudsari, M.D., Study chair, Assistant proffessor of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625442
- Sponsor's protocol ID
- 3132012
- Other IDs
- 3132012n
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01625442
- Acronym / sponsor ID
- 3132012
- Keywords
- Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- Birjand University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saffron | Active comparator | Drug: Saffron tabletSaffron treatment group received saffron tablets daily for 45 days |
| Barberry | Active comparator | Drug: Barberry tabletBarberry group received barberry tablets daily for 45 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group received placebo tablets daily for 45 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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-
Key exclusion criteria (5 listed)
- using insulin or glucose sensitizing medication
- preexisting cardiovascular disease
- psychiatric problems
- non-compliance of patients
- not presenting at times determined for treatment and evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saffron tabletAlso: crocinSaffron tablets 100 mg | Drug | Saffron |
| Barberry tabletBarberry tablets 200 mg | Drug | Barberry |
| PlaceboPlacebo tablets received daily for 45 days | Drug | Placebo |
Primary outcome
Serum LDL cholesterol
Time frame: after 45 days of treatment
Serum LDL cholesterol after 45 days of treatment in three study groups
5 secondary outcomes
Serum total cholesterol
Time frame: after 45 days of treatment
serum HDL cholesterol
Time frame: after 45 days of treatment
serum triglyceride
Time frame: after 45 days of treatment
Fasting Blood Sugar
Time frame: after 45 days of treatment
Hematocrit
Time frame: after 45 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayyebeh Kermani, Ph.D. principal investigator
Assistant proffessor of anatomy
Maryam Navabzadeh, M.D. study director
Traditional iranian medicine specialist
Gholamreza Sharifzadeh, M.S. principal investigator
Biostatistician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saffron tablet and Barberry tablet in people with Metabolic Syndrome and Hypercholesterolemia, run by Birjand University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum LDL cholesterol (time frame: after 45 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.