The aim of this study is evaluation of standardized cinnamon capsule’s clinical effect on MS patient’s quality of life and fatigue. This study is a double blind clinical trial is in two group of drug and placebo. Sample size of study is 60 and randomly 30 of them put in drug group and 30 of them put in placebo group. (Including criteria’s: proved MS disease according to clinical examination and disease history, Expanded Disability Status Scale (EDSS) score 2 – 5.5, had a regular drug therapy and no change in drugs for last 4 weeks) (Excluding criteria’s: history of drug or alcohol abuse, pregnancy or lactation during the last 12 months, renal or liver failure, and steroid therapy during last two months, another neurologic disease except MS, cardiovascular disease, or infection and sensitivity to cinnamon) patients will observe for 3 month,Each capsule contain 0.5 g dried cinnamon powder that patient eat four capsule a day. (Every 6 hours)
. Assessment of patient will be with standardized questionnaires MSQOL-54, FSS.
General information
Acronym
M.S
IRCT registration information
IRCT registration number:IRCT201312024610N2
Registration date:2013-12-19, 1392/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-19, 1392/09/28
Registrant information
Name
Foroogh Namjoyan
Name of organization / entity
School of pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8380
Email address
f.namjooyan@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research,Ahvaz Jundishapur Uiversity of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-09-02, 1392/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of standardized cinnamon capsules on quality of life and fatigue of Multiple Sclerosis patients reffeing to Khuzistan M.S society
Public title
Effect of cinnamon supplement on multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria’s: proved MS disease according to clinical examination and disease history; Expanded Disability Status Scale (EDSS) score 2 – 5.5; had a regular drug therapy and no change in drugs for last 4 weeks.
Excluding criteria’s: history of drug or alcohol abuse, pregnancy or lactation during the last 12 months, renal or liver failure; and steroid therapy during last two months; another neurologic disease except MS; cardiovascular disease; or infection and sensitivity to cinnamon.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Pharmacy School, Jundishapur University of Medical Sciences, Golestan street,Jundishapur Medical University Campus,Ahvaz,Iran
City
Ahvaz
Postal code
Approval date
2012-07-16, 1391/04/26
Ethics committee reference number
eth-540
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
Timepoint
1 month
Method of measurement
questionnarie
Secondary outcomes
1
Description
quality of life
Timepoint
1 month
Method of measurement
questionnaire
Intervention groups
1
Description
intervention 1: patient in drug group every 6 hour eat 1 drug capsule. examination will be with questionnaire in first day and end of first,second and third month.
Category
Treatment - Drugs
2
Description
intervention 2: patient in placebo group every 6 hour eat 1 placebo capsule. examination will be with questionnaire in first day and end of first,second and third month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khuzistan MS Assosiasion
Full name of responsible person
Dr.Nastaran Majdi Nasab
Street address
School of Rehabilitation, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Foroogh Namjooyan
Position
pharmacognosy Ph.D, pharmacognosy department, school of pharmacy
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8380
Fax
+98 61 1373 8381
Email
forooghnamjooyan@yahoo.comnamjoyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Foroogh Namjooyan
Position
Ph.D
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8380
Fax
Email
forooghnamjooyan@yahoo.com
namjoyan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Rahil Ghanavati
Position
Pharmacy student
Other areas of specialty/work
Street address
School of Pharmacy,Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
00
Fax
Email
ghanavati.r@ajums.ac.ir
rahil_ghanavati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)