Protocol summary

Summary
The aim of this study is to investigate the effect of saffron petals on dyslipidemic disorders among individuals with dyslipidemia. A total of 50 patients with dyslipidemia (HDL≤40; LDL≥130; TG≥200; total cholesterol≥200 mg/dl), ranging from 30 to 60 years, irrespective of gender, will be selected by convenience sampling method and included upon providing written consent. Recruitment will take place in the office of a cardiovascular disease specialist. Then, the selected participants will be randomly allocated into placebo and saffron groups using random digits table. Additionally, the study is triple-blind, meaning that the patient, the data collector, and the statistical analyst are unaware of the type of intervention throughout the study. The patients in the intervention and control groups will use, respectively, one pill of saffron and placebo orally at a dose of 30 mg/kg per body weight on a daily basis for four weeks after one or another main meal of the day. Before and 28 days after the intervention, patient blood samples will be taken to measure HDL, LDL, TG, and total cholesterol.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016083017756N4
Registration date: 2016-09-15, 1395/06/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-15, 1395/06/25
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
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of the effects of saffron petals' aqueous extract on lipid profile in patients with dyslipidemia
Public title
An inquiry into saffron's effects on dyslipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with lipid disorders (HDL≤40; LDL≥130; TG≥200; total cholesterol≥200 mg/dl); Not receiving antidyslipidemic drugs; age from 30 to 60 years; no history of stroke or heart surgery; lack of genetic dyslipidemic disease; provision of informed consent. Exclusion criteria: use of antidyslipidemic drugs during the study; incidence of myocardial infarction or heart surgery during the study; occurrence of unexpected circumstances for the participant such as an accident, death, etc.; failure to use saffron or placebo pills during the study, even for a single day
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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari St.
City
Birjand
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
Ir.bums.1394.54

Health conditions studied

1

Description of health condition studied
Dyslipidemia
ICD-10 code
e78.1
ICD-10 code description
Pure hyperglyceridaemia

Primary outcomes

1

Description
Triglyceride
Timepoint
Before and 28 days after intervention
Method of measurement
Pars Azmoon kit and Autoanalyzer

2

Description
Total cholesterol
Timepoint
Before and 28 days after intervention
Method of measurement
Pars Azmoon kit and Autoanalyzer

3

Description
LDL
Timepoint
Before and 28 days after intervention
Method of measurement
Pars Azmoon kit and Autoanalyzer

4

Description
HDL
Timepoint
Before and 28 days after intervention
Method of measurement
Pars Azmoon kit and Autoanalyzer

Secondary outcomes

1

Description
Liver enzymes
Timepoint
Before and 28 days after intervention
Method of measurement
Pars Azmoon kit and Autoanalyzer

Intervention groups

1

Description
Intervention Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Saffron petal tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables.
Category
Treatment - Drugs

2

Description
Control Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Placebo tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of Cardiovascular Disease Specialist
Full name of responsible person
Street address
No. 10, Third Alley, Taleghani St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery for Research and Technology, 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-Chancellery for Research and Technology, 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 Reyhane Hoshyar
Position
Faculty Member
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
+98 938 258 8299
Fax
Email
reyhaneh.houshyar@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 Reyhane Hoshyar
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
+98 938 258 8299
Fax
Email
reyhaneh.houshyar@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
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...