The aim of this study is to investigate the effect of Cinnamon on serum levels of inflammatory factors (IL-6 and hs-CRP), anthropometric indices (weight, body mass index and waist circumference) and pain in patients with Multiple Sclerosis. This study is a randomized double-blind clinical trial in which, 60 patients with multiple sclerosis in range of 20 to 65 years will be enrolled. Patients who their medication dosage varies during the study and have protocol violation, will be excluded. They will be divided into 2 groups. In one of the groups, cinnamon in a dose of 2 grams per day and in the other group placebo containing 2 grams of flour will be consumed by patients, for 8 weeks. Inflammatory factors at the beginning and end of the study will be evaluated. In case of positive results, Cinnamon could be used as source of anti-inflammatory and analgesic for the treatment of Multiple Sclerosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072529041N1
Registration date:2016-08-14, 1395/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Elham Delaviz
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 5287 2275
Email address
stud1861713290@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of consumption of Cinnamon on inflammatory factors , pain , and anthropometric indices in patients with Multiple Sclerosis
Public title
Effect of Cinnamon on the treatment of Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Multiple Sclerosis, non-allergic or intolerance to Cinnamon, no alcohol, absence of pregnancy or lactation, absence of hormone therapy and absence of any liver dysfunction , kidney failure, gout and rheumatoid arthritis , breast fibroids , breast cancer and avoiding the use of statins.
Exclusion criteria : Change medication , especially anti-inflammatory drugs during the study and Failure to follow study protocol.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave, Shiraz.
City
Shiraz
Postal code
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.SUMS.REC.1395.16
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
interleukin- 6
Timepoint
Before intervention, two months after intervention.
Method of measurement
Serum concentration of IL-6
2
Description
hs-CRP
Timepoint
Before intervention, two months after intervention.
Method of measurement
Serum concentration of hs-CRP
Secondary outcomes
1
Description
Weight
Timepoint
Before intervention, two months after intervention
Method of measurement
Weight in (kg)
2
Description
Waist circumference
Timepoint
Before intervention, two months after intervention
Method of measurement
Upper hip bone and place a measuring tape around the abdomen
3
Description
body mass index
Timepoint
Before intervention, two months afte intervention
Method of measurement
Weight in Kilograms over Height in meters squared
4
Description
Total protein intake
Timepoint
Before intervention, two months after intervention
Method of measurement
Dietary recall questionnaire
5
Description
Total carbohydrate intake
Timepoint
Before intervention, two months after intervention
Method of measurement
Dietary recall questionnaire
6
Description
Total fat intake
Timepoint
Before intervention, two months after intervention
Method of measurement
Dietary recall questionnaire
7
Description
Total energy intake
Timepoint
Before intervention, two months after intervention
Method of measurement
Dietary recall questionnaire
8
Description
Pain Assessment
Timepoint
Before intervention, two months after intervention
Method of measurement
Pain Quality Assessment Scale
Intervention groups
1
Description
Cinnamon with daily dose 2 gr for 2 month
Category
Treatment - Drugs
2
Description
Cap containing placebo, 2 gr flour for daily usage for 2 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society of Shiraz
Full name of responsible person
Keramat Nazari
Street address
MS Society of Shiraz, Qsraldsht Ave,Shiraz.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Musa Salehi
Street address
Shiraz University of Medical Sciences, Zand Ave, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elham Delaviz
Position
Student of master of science of nutrition science
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Ave, Shiraz.
City
Shiraz
Postal code
Phone
+98 61 5287 2275
Fax
Email
e.delaviz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Nutrition and Food Sciences
Full name of responsible person
Musa Salehi
Position
PhD Nutrition Sciences
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd,Shiraz.
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
e.delaviz@yahoo.com, salehi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Delaviz
Position
Student of master of science of nutrition science
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
+98 61 5287 2275
Fax
Email
e.delaviz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)