Evaluation of the effect of Jadwar on quality of life and fatigue of multiple sclerosis patients
Design
Randomized, double-blind, placebo-controlled clinical trial; phase 2-3; with control and intervention groups, with parallel groups.
Settings and conduct
This study will be performed on MS patients in Khuzestan Province who are supported by the Khuzestan MS Association. Patients will receive routine daily treatment. These patients will be randomly divided into two groups who will randomly receive a placebo or herbal capsule. Unique codes provided by the software will be used on medicine boxes. To assess patients at the beginning and end of the intervention, quality of life and fatigue are assessed by MSQOL-54 and Fatigue Severity Scale (FSS) questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Proven MS according to clinical examinations and medical history, having stable and regular drug treatment in the last 4 weeks, having a score of EDSS disability assessment between 2 to 5.5
Exclusion criteria: pregnancy and lactation, Renal and hepatic dysfunction, neurological disease in addition to MS, Allergy to Jadwar
Intervention groups
Patients are randomly assigned to treatment and control groups. The treatment and control groups receive the capsule of Jadwar (500 mg) or placebo once a night at bedtime for 12 weeks.
Main outcome variables
Quality of life (MSQOL-54 questionnaire); Fatigue (FSS questionnaire).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046288N5
Registration date:2020-11-19, 1399/08/29
Registration timing:prospective
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Fereshteh Golfakhrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8378
Email address
golfakhrabadi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of Jadwar (Delphinium denudatum) capsules on quality of life and fatigue of multiple sclerosis patients
Public title
Effect of Jadwar capsules in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
MS has been proven by clinical examinations and medical history
Having stable and regular drug treatment in the last 4 weeks
No new attack in last month
Having a score of EDSS disability assessment between 2 to 5.5
Exclusion criteria:
Pregnancy and lactation
Renal and hepatic dysfunction
Neurologic disease in addition to MS
Cardiovascular disease or infectious disease
Allergy to Jadwar
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used. Because we have two intervention groups, equal 4 blocks is used and all 4 possible modes is created and then with Excel software we randomly select a number of blocks. Label of the medications is one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment, drug delivery and the sequence of randomization is not performed by researchers and evaluators while is the responsibility of another individual .
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, are assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators are not aware of the assigned groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences,, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-10-31, 1399/08/10
Ethics committee reference number
IR.AJUMS.REC.1399.624
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
Fatigue
ICD-10 code
F48.0
ICD-10 code description
Fatigue
Primary outcomes
1
Description
Fatigue rate
Timepoint
The first day of intervention and three months later
Method of measurement
FSS questionnaires
2
Description
Quality of Life
Timepoint
The first day of intervention and three months later
Method of measurement
Questionnaire MSQL54
Secondary outcomes
1
Description
Side effects of the drug
Timepoint
Three months after the start of the intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Capsule of Jadwar 500 mg once daily for three months
Category
Treatment - Drugs
2
Description
Control group: Capsule of placebo once daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital in Ahvaz
Full name of responsible person
Fereshteh Golfakhrabadi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghaddam
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
golfakhrabadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
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
Only part of the data will be shared
When the data will become available and for how long
The access time is up to 6 months after the results are published
To whom data/document is available
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis
Under which criteria data/document could be used
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com
What processes are involved for a request to access data/document
Applicants will have access to the data from the present study by emailing the responsible author for up to one month. golfakhrabadi@yahoo.com