Assesment of the effect of supplemental aqueous extracts of Achillea milefolium on the symptoms, severity and memory deficits in Rafsanjan Multiple sclerosis patients
This study follows a previous study group to examine the possible effects of aqueous extracts of yarrow in patients with MS has been developed. The results of this study may introduce a new herbal supplement to help treat MS patients is beneficial . Inclusion criteria were an age of 16 to 55 years; a diagnosis of multiple sclerosis, according to the revised McDonald criteria; a relapsing–remitting course; one or more documented relapses in the previous year or two or more in the previous 2 years; and a score of 0 to 5.5 on the EDSS. exclusion criteria were relapse or corticosteroid treatment within 30 days before randomization, active infection, or clinically significant systemic disease. The sample size is 75 people. intervention is Drug treatment and primary end points are change in EDSS score and defined as the number of confirmed
relapses per year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121915863N1
Registration date:2014-03-12, 1392/12/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-12, 1392/12/21
Registrant information
Name
Fatemeh Ayoobi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1422 6123
Email address
ayoobi_fatemeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of the effect of supplemental aqueous extracts of Achillea milefolium on the symptoms, severity and memory deficits in Rafsanjan Multiple sclerosis patients
Public title
Assesment of the effect of supplemental aqueous extracts of Achillea milefolium in Multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were an age of 16 to 55 years; a diagnosis of multiple sclerosis, according to the revised McDonald criteria; a relapsing–remitting course; one or more documented relapses in the previous year or two or more in the previous 2 years; and a score of 0 to 5.5 on the EDSS. exclusion criteria were relapse or corticosteroid treatment within 30 days before randomization, active infection, or clinically significant systemic disease.
Age
From 16 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Enghlab Square
City
Rafsanjan
Postal code
Approval date
2014-02-02, 1392/11/13
Ethics committee reference number
31/9/3040
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
Disability
Timepoint
Before the experiment, three months after the intervention, and six months after intervention
Method of measurement
Expanded Disability Status Scale
2
Description
relapse rate
Timepoint
Course of treatment
Method of measurement
number of confirmed relapses per year
Secondary outcomes
1
Description
Different aspects of cognitive abilities
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Mini-Mental Status Examination tese
2
Description
Functional disability and cognitive
Timepoint
Before the experiment and six months after the intervention
Method of measurement
MULTIPLE SCLEROSIS FUNCTIONAL COMPOSITE test
3
Description
Learn Paired of words
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Paired words test
4
Description
Abstract reasoning and cognitive ability to adapt to environmental challenges
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Wisconsin card sorting test
5
Description
Anxiety
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Spielberger state-trait anxiety inventory
6
Description
Fatigue
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Fatigue Severity Scale test
7
Description
Depression
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Beck Depression Inventory
8
Description
Spasticity
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
Ashworth test
9
Description
number of gadolinium-enhancing lesions
Timepoint
Before the experiment and six months after the intervention
Method of measurement
MRI
10
Description
New lesion
Timepoint
Before the experiment and six months after the intervention
Method of measurement
MRI
11
Description
Resolvent
Timepoint
Before the experiment, three months and six months after the intervention
Method of measurement
TOWER OF LONDON TEST
Intervention groups
1
Description
Control group: placebo group (placebo) are used. Daily for six months with a number of food consumed. Dose: 250 Mlylygrm capsules containing starch
Category
Treatment - Drugs
2
Description
Intervention group: a group of extract at a dose of 500 mg capsules to take. Daily for six months with a number of food
Category
Treatment - Drugs
3
Description
Intervention group: a group of extract at a dose of 250 mg capsules to take. Daily for six months with a number of food
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic Hospital, Ali ibn Abi Talib
Full name of responsible person
Doctor Amir Ahmadi Moghaddam - board certified Neurology - Assistant Professor
Street address
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Doctor Mohammad Mirzai
Street address
Rafsanjan University of Medical Sciences
City
Rafsanjan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
fatemeh Ayoobi
Position
PhD research - Collaboration Pharmacology Physiology Research Center
Other areas of specialty/work
Street address
Enghlab Square, Rafsanjan University of Medical Sciences
City
Rafsanjan
Postal code
7719617996
Phone
+98 39 1523 4003
Fax
Email
ayoobi_fatemeh@yahoo.comalishamsy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Doctor Ali Shamsi-Zadeh
Position
PhD in Physiology
Other areas of specialty/work
Street address
School of Medical Sciences, Rafsanjan
City
Rafsanjan
Postal code
7719617996
Phone
+98 39 1523 4003
Fax
Email
alishamsy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
fatemeh Ayoobi
Position
PhD Student of research
Other areas of specialty/work
Street address
City
Rafsanjan
Postal code
7719617996
Phone
+98 39 1523 4003
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)