The aim of this study was to determine the effect of saffron crocin on sleep quality, general health and happiness in the elderly.
Design
Study design: Clinical trial with control group, with parallel groups, triple blind, randomized, phase 3 on 70 patients. Coin toss will be used for randomization.
Settings and conduct
70 elderly referring to health centers affiliated with Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. In this way, the days of the week will be divided into two groups: even and odd, the elderly will be in one group on even days and the individual will be in another group on odd days. In this study, investigators, study participants, and Statistical Analyst will not know the type of supplement prescribed for the patient until the end of the data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the intervention and Ability to communicate verbally
Exclusion criteria: History of allergy to saffron plant products and Complaints of known psychological illness and Alzheimer
Intervention groups
Intervention: elderly will be assigned to receive either crocin (n=35) or placebo (n=35)
Main outcome variables
Pittsburgh Sleep Quality (Primary outcome), Goldberg Public Health and Oxford Happiness (Secondary outcomes) will be measured at the beginning of the study; at the end of the fourth week and one month after the last day of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200616047800N1
Registration date:2020-08-09, 1399/05/19
Registration timing:prospective
Last update:2020-08-09, 1399/05/19
Update count:0
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Narges Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
sadeghi.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-11, 1399/05/21
Expected recruitment end date
2020-10-12, 1399/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of crocin of saffron on sleep quality, general health and happiness in elderly population
Public title
The effect of crocin of saffron on sleep quality, general health and happiness in elderly population
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the intervention
Ability to communicate verbally
Get a score of 22 or higher on the general health questionnaire, score 5 and above on the sleep quality questionnaire and a score of 42 or less on the happiness questionnaire at the beginning of the study
Exclusion criteria:
History of allergy to saffron plant products
Complaints of known psychological illness and Alzheimer's
Taking crocin and antioxidant supplements during the last 3 months before the intervention
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The days of the week will be divided into two groups: even and odd, the elderly will be in one group on even days and the individual will be in another group on odd days.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, investigators, study participants, and Statistical Analyst will not know the type of supplement prescribed for the patient until the end of the data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.011
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Happiness
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Quality of sleep
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of sleep
Timepoint
At the beginning of the study, 4 and 8 weeks after intervention
Method of measurement
The Pittsburgh Sleep Quality Index
2
Description
General Health
Timepoint
At the beginning of the study, 4 and 8 weeks after intervention
Method of measurement
Goldberg General Health
Secondary outcomes
1
Description
Happiness
Timepoint
At the beginning of the study, 4 and 8 weeks after intervention
Method of measurement
Oxford Happiness
Intervention groups
1
Description
Intervention group: Crocin capsule, two oral 15 mg capsule, twice a day for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo capsule, two oral 15 mg capsule, twice a day for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Health Center
Full name of responsible person
Mohammad Afshar
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
SADEGHI_H@SKUMS.AC.IR
Web page address
http://www.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
Kashan
Province
Isfehan
Postal code
87135/1416
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
SADEGHI_H@SKUMS.AC.IR
Web page address
http://www.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
kashan
Province
Isfehan
Postal code
87135/1416
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
SADEGHI_H@SKUMS.AC.IR
Web page address
http://www.kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
kashan
Province
Isfehan
Postal code
87135/1416
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
SADEGHI_H@SKUMS.AC.IR
Web page address
http://www.kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
kashan
Province
Isfehan
Postal code
87135/1416
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
SADEGHI_H@SKUMS.AC.IR
Web page address
http://www.kaums.ac.ir/
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
No - There is not 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
At the end of the intervention, unidentified data will be disseminated.
When the data will become available and for how long
The data access period will start after the intervention.
To whom data/document is available
The data of this study will be made available to academic researchers and industry professionals.
Under which criteria data/document could be used
Unidentifiable study data for use in industry and meta-analytical studies will be made available to academic researchers and industry professionals.
From where data/document is obtainable
To access the study data, send a message to afshar_m_1344@yahoo.com or refer to Kashan University of Medical Sciences.
What processes are involved for a request to access data/document
After sending a written request to the main person in charge of this project (Dr Mohammad Afshar) and explaining the purpose of obtaining the study data, unidentifiable data will be provided to her.