Protocol summary

Summary
The aim of this double-blind study was to investigate the effects of Berberis vulgaris fruit extract, saffron (Crocus Sativus L.) and placebo on metabolic syndrome. The population in this third-phase clinical trial included all patients referred to cardiac outpatient clinic of Birjand University of Medical Sciences. A total of 90 patients who were diagnosed with metabolic syndrome, aged between 30 and 60 years, and were willing to participate in the study were randomly selected and allocated into three groups through simple randomization method. A total of 30 patients were allocated into the saffron group, 30 into barberry group, and 30 into the placebo group. The saffron group received on a daily basis a tablet of 100 mg of crocin (constituent of saffron) on a daily basis for three weeks. The barberry group received three 550 mg tablets of Berberis vulgaris fruit extract (an aqueous extract) per day for three weeks. The placebo group received starch tablets, similar in appearance to tablets in other groups, one per day for three weeks. Metabolic syndrome variables, i.e., body mass index, blood pressure, fat distribution pattern, fasting blood sugar, serum lipid level, triglycerid, total cholesterol, and low and high density lipoprotein were measured at baseline and at the end of interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112617756N11
Registration date: 2017-01-02, 1395/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2008-03-20, 1387/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of saffron (Crocus Sativus L.), Berberis vulgaris fruit extract, and placebo on components of metabolic syndrome in patients with metabolic syndrome
Public title
Effects of saffron and barberry on components of metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 30 and 60 years; individuals with metabolic syndrome defined by the Adult Treatment Panel III (ATP III); provision of informed consent; absence of any history of major cardiac, pulmonary, hepatic, gastroenterological, neurologic, psychiatric, or renal disease; non-pregnancy; Exclusion criterion: Unwillingness to continue participation
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study was double-blinded such that neither the participant was aware to which group s/he belonged nor the researcher was aware which particular participant belonged to which group under study. Furthermore, the ethical code of the study is 02-02-87. It is because prior to the year 2015, ethical codes were issued based on, and in the format of, the date the Ethics Committee's meeting was held to proceed the research project.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2008-04-21, 1387/02/02
Ethics committee reference number
02-02-87

Health conditions studied

1

Description of health condition studied
Metabolic disorder
ICD-10 code
E88
ICD-10 code description
Other metabolic disorders

Primary outcomes

1

Description
Body Mass Index
Timepoint
Before intervention and three weeks after intervention
Method of measurement
a Seca 200 scale with attached stadiometer

2

Description
hypertension
Timepoint
Before intervention and three weeks after intervention
Method of measurement
mercury sphygmomanometer

3

Description
fasting blood sugar (FBS)
Timepoint
Before intervention and three weeks after intervention
Method of measurement
ParsAzmun kit

4

Description
triglyceride (TG)
Timepoint
Before intervention and three weeks after intervention
Method of measurement
ParsAzmun Kit

5

Description
total cholesterol (Chol)
Timepoint
Before intervention and three weeks after intervention
Method of measurement
ParsAzmun Kit

6

Description
low- and high-density lipoprotein (LDL and HDL)
Timepoint
Before intervention and three weeks after intervention
Method of measurement
ParsAzmun Kit

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group (saffron group): tablets of 100 mg of crocin (constituent of saffron) one per day for 3 weeks
Category
Treatment - Drugs

2

Description
The second intervention group (barberry group): three tablets of 550 mg Berberis vulgaris fruits extract per day for three weeks
Category
Treatment - Drugs

3

Description
The placebo group: starch tablets one per day for three weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
cardiac outpatient clinic of Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Vali-Asr Hospital, Ghaffari St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Position
Vice-chancellor for Research and Technology
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 1200
Fax
Email
drtooba.kazemi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Position
Full Professor
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
+98 56 3239 1200
Fax
Email
drtooba.kazemi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...