determination impact of hemp seeds consumption on the general health of the elderly who refer to health centers in Rafsanjan, 2024
Design
A clinical trial with a control group, with parallel groups, three blind strains, randomly assigning samples using the minimization method, number of samples: 70
Settings and conduct
In this research, hemp seed powder will be used in the form of oral capsules for the test groups. The dosage of the extract and dosage based on similar studies will be considered 700 mg three times a day for 4 weeks. The current study is a triple-blind clinical trial that will be conducted with the aim of investigating the use of hemp seed on the general health of the elderly who refer to health service centers in Rafsanjan
Participants/Inclusion and exclusion criteria
1- Not having a history of allergy to herbal medicine
2- Not suffering from an incurable physical disease
3- Voluntary acceptance of participation in the research
4- Being at least 60 years old
5- Not using any other type of psychological intervention during the time period of holding treatment sessions
6- Not having a history of an unfortunate accident in the last six months
7- No addiction to drugs, narcotics, alcohol, or the use of psychoactive drugs
8- Not having a known mental illness
Intervention groups
In this research, ready-made seed powder in the form of edible capsules will be used for the test groups. The dosage of the extract and dosage based on similar studies will be considered 700 mg three times a day for 4 weeks. The medicine will be listed and marked by the pharmacist to the applicants. In the case of the control group, corn starch capsules will be used. The drug and placebo are filled in capsules of the same color and size and packed in the same cans and coded by the pharmacist.
Main outcome variables
general health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171002036498N6
Registration date:2024-05-05, 1403/02/16
Registration timing:prospective
Last update:2024-05-05, 1403/02/16
Update count:0
Registration date
2024-05-05, 1403/02/16
Registrant information
Name
Ali Akbari
Name of organization / entity
Medical Sciences of Rafsanjan University
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
iccn@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating impact of hemp seeds consumption on the general health of the elderly who refer to health centers in Rafsanjan, 2024
Public title
Investigating impact of hemp seeds consumption on the general health of the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Not having a history of using herbal medicines
Absence due to incurable physical illness
Voluntary acceptance of participation in the research
Being at least 60 years old
Using any type of psychological intervention during the time period of holding other treatment sessions
Not having an accident in the last six months
Not taking medicine, drugs, alcohol or psychotropic drugs
Not having a known mental illness
Exclusion criteria:
1- Unwillingness of the participants to continue the treatment
Suffering from any disease during the research period that leads to prohibition of hemp consumption by the individual
- Showing an allergic reaction to hemp seeds
Not taking hemp capsules regularly for at least two consecutive days
Using hemp in the diet
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples will be done randomly by minimization method based on gender variables and general health score before intervention into two groups A and B. In this method, first the classes are formed based on the desired variables, then the first two samples are randomly placed in two groups. For the next samples, the sum of indicators in two groups is considered and the sample is assigned to the group that has a lower sum
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be conducted triple blinded, the subjects, the researcher and the treating physician in this study will not know about the type of intervention, and cannabis capsules and placebo will be provided to people by another person as a colleague. Capsules. They will be labeled A and B by the pharmacist, and at the end of the study, they will announce the types of groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan, Imam Ali Boulevard, Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.RUMS.REC.1403.010
Health conditions studied
1
Description of health condition studied
General health
ICD-10 code
Z10
ICD-10 code description
Routine general health check-up of defined subpopulation
Primary outcomes
1
Description
In this study, general health is the score that the samples of the research are obtained from the Goldberg 28 Public Health Questionnaire. In each question the score of 0 is the lowest score, the score of 3 is the highest score. As a result, each person's total score will be between 0 and 84.
Timepoint
Before, the end of the intervention and one month after the intervention
Method of measurement
GHQ-28 General Health Questionnaire
Secondary outcomes
1
Description
General health
Timepoint
Before the end of the intervention and one month after the end of the intervention
Method of measurement
GHQ-28 General Health Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: In this research, hemp seed powder in the form of oral capsules will be used for the test groups. The dosage of the extract and dosage based on similar studies will be considered 700 mg three times a day for 4 weeks. The medicine will be given to the clients based on the checklist and marked by the pharmacist. Medicine and placebo are filled in capsules of the same color and size and packed in the same cans and coded by the pharmacist.
Category
Treatment - Drugs
2
Description
Control group: In this research, corn starch in the form of edible capsules will be used for the control groups. The dosage based on similar studies, such as the intervention group, will be 700 mg three times a day for 4 weeks. Medicines will be given to clients with a list and marked by the pharmacist. The medicine and placebo are filled in capsules of the same color and size, packed in the same cans and coded by the pharmacist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
Full name of responsible person
Ali Akbari
Street address
West Shariati Boulevard, No. 7, Banafshe St
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Rafsanjan, Imam Ali Blvd., Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Shariati Blvd., Banafshe Street, Plate 7
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Shariati Blvd., Banafshe Street, Plate 7
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Shariati Blvd., Banafshe Street, Plate 7
City
Rafsanjan
Province
Kerman
Postal code
7619868468
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available