Participants in the study are selected from the male and female dormitory students of Shahed University who volunteered to participate in the project, after mental evaluation by GHQ questionnaire and having inclusion criteria. Taking medication and placebo for 2 weeks and twice a day after a meal. Also, the checklist for using the medication reminder and the registration form of drug side effects will be filled in by the mentioned people. In order to control the complete use of the drug combination, follow-up is done by phone every week. At the end of the treatment period, individuals are re-examined and questionnaires are filled out.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Indivisual's mental health ( indivisuals with scores lower than 7 in the depression section of GHQ mental health questionnaire , who will be referred to as "healthy indivisuals" in his study. Obtaining informed consent
Exclusion criteria: Mental disease according to GHQ mental health questionnaire; Pregnancy or lactation
Intervention groups
Medication group and placebo group
In the drug group, people in the saffron capsule group are given 500 mg capsules containing 75 mg of saffron powder and 425 mg of bread powder, which are packed in 42-digit cans.
In the placebo group, people are given exactly the same capsule containing bread powder and food coloring (500 mg) packed in 42-digit cans.
Main outcome variables
Happiness; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200813048396N1
Registration date:2021-01-10, 1399/10/21
Registration timing:prospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Mohsen Keyhan Soltani Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 9176
Email address
mksoltani47@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy of Saffron on happiness and quality of life in healthy adults
Public title
Assessment of the efficacy of Saffron on happiness and quality of life in healthy adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Indivisual's mental health ( indivisuals with scores lower than 7 in the depression section of GHQ mental health questionnaire , who will be referred to as "healthy indivisuals" in his study
Obtaining informed consent
Exclusion criteria:
History of mental disease according to GHQ mental health questionnaire
Pregnancy or lactation
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study will take advantage of the random allocation method through the table of random numbers to develop subjects to the two intervention and placebo groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
Initially, 500 mg capsules of the drug containing 75 mg of saffron and 425 mg of bread powder are prepared and for the control group, using capsules similar to the main drug , with the same weight containing bread powder , which is similar to the intervention sample, is prepared . After preparation of drugs and placebos, the pharmacist researchers will assign a code to the medicine researchers will not know if each participant is in the medication group or the placebo group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Persian Gulf freeway, in front of the Holy Shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SHAHED.REC.1399.051
Health conditions studied
1
Description of health condition studied
Healthy people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in happiness questionnaire score
Timepoint
Before intervention, Two weeks after starting the study
Method of measurement
Oxford questionnaire
2
Description
Change in quality of life questionnaire score
Timepoint
Before intervention, Two weeks after starting the study
Method of measurement
SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Saffron in the form of 500 mg capsules containing 75 mg of saffron powder and 425 mg of bread powder, which is packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal. Saffron product is also determined based on the amount of crocin, determined and standardized.
Category
Treatment - Drugs
2
Description
Control group: The capsules are prepared in exactly the same way as bread powder and food coloring (500 mg) and are packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed University dormitory
Full name of responsible person
Mohsen-Keyhan Soltani Hosseini
Street address
Persian Golf freeway, in front of the Holy Shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
mksoltani47@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Street address
Persian Golf freeway, in front of Holy Shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
naseri@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Keyhan Soltani Hosseini
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.37 , Boostan 8th , Pasdaran Avenue
City
Tehran
Province
Tehran
Postal code
1666677311
Phone
+98 21 2258 9176
Email
mksoltani47@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Golf freeway, in front of Holy Shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
naseri@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Keyhan Soltani Hosseini
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 37 , Boostan 8th . Avenue Pasdaran
City
Tehran
Province
Tehran
Postal code
1666677311
Phone
+98 21 2258 9176
Email
mksoltani47@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after identifying individuals
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers in academic centers
Under which criteria data/document could be used
After receiving the request, the amount of access will be announced
From where data/document is obtainable
Dr Mohsen Naseri
What processes are involved for a request to access data/document
One month after receiving the written request, the result will be announced