The aim of this placebo controlled double blind randomized clinical trial is evaluating the effects of Rosmarinus officinalis L. on memory function, mental health, sleep quality and oxidative stress in university students. Inclusion criterion is students ranged in age from 20 to 25 years old. The main exclusion criteria are lactation and pregnancy. A total of 50 students will be recruited from Kerman University of Medical Sciences. These students will be divided in to two groups (intervention and placebo), each have 25 patients, using block randomization. After signing informed consent form by students, powdered rosemary will be administered as one 500 mg capsule twice daily for one month in interventional group and students will take placebo with the same dose and frequency in control group. Memory function, depression, anxiety and sleep quality will be evaluated using self-reported questionnaires at baseline and after one month. Also, oxidative stress biomarkers is measured at baseline and after one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703136026N6
Registration date:2017-05-01, 1396/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2017-04-01, 1396/01/12
Expected recruitment end date
2018-04-01, 1397/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of Rosmarinus officinalis L. on memory function, mental health, sleep quality and oxidative stress in university students
Public title
Evaluating the effects of Rosmarinus officinalis L. on memory function, mental health, sleep quality and oxidative stress in university students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: University student in the 20-25 age range; Having an underlying disease
Exclusion: Pregnancy; Lactation
Age
From 20 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Tahmasb abad Ave
City
Kerman
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.KMU.REC.1395.1016
Health conditions studied
1
Description of health condition studied
Memory
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
2
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
3
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
4
Description of health condition studied
Sleep disorder
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Memory
Timepoint
At baseline and after 1 month
Method of measurement
Questionnaire
2
Description
Oxidative stress
Timepoint
At baseline and after 1 month
Method of measurement
Oxidative stress biomarkers
Secondary outcomes
1
Description
Mental disorders
Timepoint
At baseline and after 1 months
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: one 500 mg powdered rosemary twice daily for one month
Category
Treatment - Drugs
2
Description
Control: One placebo capsule twice daily for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Street address
Haft-Bagh High-Way
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Univesity of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Tahmasb abad Ave
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Univesity 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 3132 5212
Fax
Email
Fatemeh_dabaghzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciencers
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 3132 5212
Fax
Email
Fatemeh_dabaghzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)