Evaluation Of Effectiveness Of The Lavander Flower (Lavandula angustifolia Mill) On Fatigue In Multiple Sclerosis Patients - Double-Blind Clinical Trial
Determination of the Effect of Lavender on the Mean Score of MFIS (Modified Fatigue Impact Scale
) Questionnaire in Patients with Multiple Sclerosis Compared to Placebo
Design
This study is a double-blind clinical trial. 60 patients are randomly divided into intervention and placebo groups (30 patient in each group)
Settings and conduct
This study is performed on patients with MS who are registered in the Kerman Neurology Research Center. Based on the inclusion and exclusion criteria, 60 patients are selected and entered into the study after completing the consent form.Patients are randomly assigned to one of two groups (intervention and placebo). The researcher and patients are not aware of the contents of the drug packages.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Definitive diagnosis of MS according to McDonald's criteria and confirmed by a neurologist; Relapsing-remitting type of MS; Having symptoms of fatigue; Expanded Disability Status Score (EDSS) of less than or equal to 6; No disease attack during the last month; Not using other medication during study. Exclusion criteria: Disease attack during the study; The emergence of drug complications; Not willingness to continue the study; Pregnancy; Breastfeeding.
Intervention groups
Intervention group:receiving 500 mg capsule (600 mg lavender) every 8 hours and placebo group: receiving 500 mg capsule (corn starch) every 8 hours
Main outcome variables
Fatigue in patients with multiple sclerosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190710044166N1
Registration date:2019-09-03, 1398/06/12
Registration timing:prospective
Last update:2019-09-03, 1398/06/12
Update count:0
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Najmeh Motaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3248 1040
Email address
n.motaghi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of Effectiveness Of The Lavander Flower (Lavandula angustifolia Mill) On Fatigue In Multiple Sclerosis Patients - Double-Blind Clinical Trial
Public title
Efficacy of lavender in the treatment of fatigue in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of MS according to McDonald's criteria and confirmed by a neurologist
Relapsing-remitting type of MS
Having symptoms of fatigue
Expanded Disability Status Score (EDSS) of less than or equal to 6
No disease attack during the last month
Not using other medication during the study
No Depression disease Based on Beck Questionnaire
No history of other diseases such as autoimmune disease, malignancy
No usind of drugs such as antipsychotic , monoamine oxidase inhibitors, benzodiazepines, tricyclic antidepressants, anticonvulsants and barbiturates
Exclusion criteria:
Disease attack during the study
The emergence of drug complications
Not willingness to continue the study
Pregnancy
Breastfeeding
Age
From 18 years old
Gender
Both
Phase
N/A
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
Block Randomization(4 block)
In this study, there are two groups A and B (Medicine and placebo). In the 4 blocks, there are 6 groups of positions A and B
(AABB, ABAB, BAAB, BABA, BBAA, ABBA). By using the random number table, the order of these 6 states is determined. Finally, the entry of groups A and B are determined according to the 6 states and the random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are packaged and coded by the pharmacist and the researcher and patient are unaware of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Research Vice-Chancellor, Ebn Sina Avenue
City
Kerman
Province
Kerman
Postal code
7619837773
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.KMU.REC.1398.253
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
Fatigue score on the MFIS questionnaire
Timepoint
At baseline and two months after drug administration
Method of measurement
MFIS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of 3 capsules 500 mg (containing 600 mg lavender) every 8 hours for 2 months
Category
Treatment - Drugs
2
Description
Control group: Recipient of 3 capsules 500 mg (containing corn starch) every 8 hours for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Research Center
Full name of responsible person
Najmeh Motaghi
Street address
Neurology Research Center, Alley 22, Shafa Avenue
City
Kerman
Province
Kerman
Postal code
7618759639
Phone
+98 34 3212 4727
Email
kmu.nrc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Vahid Sheibani
Street address
Neuroscience Research Center, Ebn Sina Avenue
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
info.knrc@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Motaghi
Position
Ph.D Student of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
College of Traditional Iranian Medicine, Amir Kabir Crossroads, Jomhori Blvd.
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0123
Email
n.motaghi34@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Motaghi
Position
Ph.D Student of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
College of Traditional Iranian Medicine, Amir Kabir Crossroads, Jomhori Blvd.
City
Kerman
Province
Kerman
Postal code
761883883
Phone
+98 34 3211 0123
Email
n.motaghi34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Motaghi
Position
Ph.D student of pershian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
College of Traditional Iranian Medicine, Amir Kabir Crossroads, Jomhori Blvd.
City
Kerman
Province
Kerman
Postal code
761884883
Phone
+98 34 3211 0123
Email
n.motaghi34@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After completing the study, the information on the main outcome will be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers and other people can access data if they need it.
Under which criteria data/document could be used
The data and results can be used for review article, reprogramming and modeling in other studies after printing results.
From where data/document is obtainable
Email: n.motaghi34@yahoo.com
What processes are involved for a request to access data/document