The aim of this study is to determine the effects of curcuminoids supplementation on mental health and sleep quality in elderly.
Design
Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 70 patients, phase 3
Settings and conduct
70 elderly referring to health centers affiliated with Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. In this study, investigators and study participants will not know the type of supplement prescribed for the patient until the end of the data analysis. Supplements and placebos are similar in shape and size. Time of intervention: 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the intervention and Ability to communicate verbally Exclusion criteria: History of allergy to curcumin plant products and complaints of known psychological illness and Alzheimer.
Intervention groups
Intervention group: capsule contains 40 mg curcuminoids (Nano Sina Elixir Company, Iran), four curcuminoid capsules daily, for 4 weeks orally. Control group: curcuminoids placebos capsule (Nano Sina Elixir Company, Iran), four capsules daily, for 4 weeks orally.
Main outcome variables
Sleep Quality and mental health (Primary outcome) 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:IRCT20220330054370N1
Registration date:2022-04-07, 1401/01/18
Registration timing:prospective
Last update:2022-04-07, 1401/01/18
Update count:0
Registration date
2022-04-07, 1401/01/18
Registrant information
Name
samira abbaszadeh-mashkani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5544 3022
Email address
abbaszadeh_sa@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-03, 1401/02/13
Expected recruitment end date
2022-07-04, 1401/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin on mental health and sleep quality in elderly
Public title
Effect of curcumin supplementation in elderly
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 mental health questionnaire
Score 3 and above on the sleep quality questionnaire
Age of 60 to 70 years old
Exclusion criteria:
History of allergy to curcumin plant products
Complaints of known psychological illness and Alzheimer's
Taking curcumin and antioxidant supplements during the last 3 months before the intervention
Age
From 60 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.KAUMS.REC.1400.060
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description
2
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
Mental health
Timepoint
At the beginning of the study, 4 and 8 weeks after intervention
Method of measurement
Goldberg Mental Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients (n=35) will be requested to take four curcuminoid capsules daily for 4 weeks (each capsules contain 40 mg curcumin). The curcuminoid capsules will be produced in the Nano Sina Elixir Company from curcuma.
Category
Treatment - Drugs
2
Description
Control group: In this group of patients (n=35) will be requested to take four placebo capsules daily for 4 weeks. The placebo capsules (Contain Starch) will be produced in the Nano Sina Elixir Company.
Category
Placebo
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
afshar_m_1344@yahoo.com
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
8814187159
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
banafshe57@hotmail.com
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
8814187159
Phone
+98 31 5554 0021
Email
afshar_m_1344@yahoo.com
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
8814187159
Phone
+98 31 5554 0021
Email
afshar_m_1344@yahoo.com
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
8713571416
Phone
+98 31 5554 0021
Email
afshar_m_1344@yahoo.com
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
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
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.