Determin the effect of Roy Jelly on quality of life and health status of multiple sclerosis patients
Design
The present study is a randomized interventional study will be performed on
two groups of 100 patients.
Settings and conduct
A study will be conducted on 100 MS patients referring to Hamadan MS Center. In the intervention group, a 500-mg capsule of royal jelly daily is given for one day for 75 days and in a daily control group one placebo for 75 days. Both groups receive the usual treatment according to expert advice. Demographic information will be completed by the researcher at the time the patient enters the department. Quality of life indicators and patient's level of health are completed once before the intervention stage and then 75 days after the intervention using the questionnaire by the researcher. Controls in the control group will not be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age is between 18 and 60 years old, Confirm Diagnosis of MS by the neurologist, Have complete and informed consent to participate in the study
Exclusion criteria: Unwillingness to continue participating in the study, Patient death
Intervention groups
In the intervention group, a 500-mg capsule of royal jelly daily is given for one day for 75 days and in a daily control group one placebo for 75 days. Both groups receive the usual treatment according to expert advice. Demographic information will be completed by the researcher at the time the patient enters the department. Quality of life indicators and patients' health level are completed once before the intervention stage and then 75 days after the intervention using the questionnaire by the researcher.
Main outcome variables
quality of life and health status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N13
Registration date:2018-06-02, 1397/03/12
Registration timing:registered_while_recruiting
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Roy Jelly on quality of life and health status of multiple sclerosis patients
Public title
The effect of Roy Jelly on quality of life and health status
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age is between 18 and 60 years
Have complete and informed consent to participate in the study
Confirm Diagnosis of MS by the neurologist
Exclusion criteria:
Patient death
Unwillingness to continue participating in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
100 patients will be selected as available, then using random blocking method, two groups of intervention (Royal) and control group will be placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.UMSHA.REC.1397.96
Health conditions studied
1
Description of health condition studied
Multiple sclerosis.
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
health status
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, a 500 mg capsule daily jelly gel containing substances such as 10-hydroxy-2-decenoic acid, B group vitamins, potassium, calcium, magnesium, zinc, iron, and copper, a number for 75 The day will be used by a neurologist. Demographic information will be completed by the researcher at the time the patient enters the department. The quality of life indicators and the level of health of the patients are completed once before the intervention stage and then 75 days after the intervention using the questionnaire by the researcher.
Category
Rehabilitation
2
Description
Control group: Except for routine medication and care, no special action will be taken.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Khodayar oshvandi
Street address
Besat St, Besat hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar oshvandi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hmadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar oshvandi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardnjani
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
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