Protocol summary

Summary
The aim of this study is to investigate the effect of oral herbal oil supplement (Cannabis sativa L, Oenothera Biennis L) and advising diet with hot nature on clinical signs and symptoms and inflammatory factors in patients with multiple sclerosis (MS). In this parallel randomized controlled trial, 99 men and women with multiple sclerosis will be recruited from center of multiple sclerosis of Emam Reza Hospital of Tabriz University of Medical Sciences. The patients will be randomized to three groups to receive 18-21 g/day of supplement oil and advising diet with hot nature, 18-21 g/day of supplement oil, or 18-21g/day of "Olive Oil" as placebo. The subjects will be required to complete 3-days, 24-hour dietary record and filled in Non-quantitative Food Frequency Questionnaires for a month, two times at four-month intervals. Diets will be analyzed for Hot or Cold nature substances and other dietary items.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804252195N1
Registration date: 2010-12-04, 1389/09/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-04, 1389/09/13
Registrant information
Name
Mehdi Farhoudi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41100983340730
Email address
farhoudim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Yashil Daroye Sahand Company
Expected recruitment start date
2010-10-27, 1389/08/05
Expected recruitment end date
2011-01-26, 1389/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral herbal oil supplement (Cannabis Sativa L, Oenothera Biennis L) and advising diet with Hot nature on clinical signs and symptoms and inflammatory factors in patients with multiple sclerosis
Public title
Effect of oral herbal oil supplement (Cannabis Sativa L, Oenothera Biennis L) and advising diet with Hot nature on multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All MS patients with clinical form of relapsing-remitting type, EDSS =<6 Exclusion criteria: Secondary or primary progressive MS, patients suffering concomitantly from another chronic diseases such as active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus, other neurological, inflammatory, or autoimmune diseases, Pregnancy, Corticostoid use, Acute phase of MS relapse
Age
From 14 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
None
Sample size
Target sample size: 99
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
Local ethics committee, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Research Vice Chancellor
City
Tabriz
Country
Iran (Islamic Republic of)
Postal code
Approval date
2010-05-28, 1389/03/07
Ethics committee reference number
8920

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
serum IL-4 concentration
Timepoint
Before intervention -6 month after intervention
Method of measurement
ELISA test

2

Description
serum IFN-Y concentration
Timepoint
Before intervention -6 month after intervention
Method of measurement
ELISA test

3

Description
EDSS (Extended disability status score )
Timepoint
Before intervention - 3month after intervention-6 month after intervention
Method of measurement
Clinical examination

4

Description
urinary PLA2 concentration
Timepoint
Before intervention -6 month after intervention
Method of measurement
ELISA test

5

Description
blood cells Polyunsaturated Fatty Acid
Timepoint
Before intervention - 6 month after intervention
Method of measurement
GC test

6

Description
serum PLA2 concentration
Timepoint
before intervention -6month after intervention
Method of measurement
ELISA test

7

Description
serum IL-17 concentration
Timepoint
Before intervention - 6 month after intervention
Method of measurement
ELISA test

8

Description
blood cells delta-6-desaturase
Timepoint
Before intervention - 6 month after intervention
Method of measurement
ELISA test

Secondary outcomes

1

Description
Changes of MRI
Timepoint
before intervention - 6 month after intervention
Method of measurement
imaging

2

Description
Drug changes of symptomatic therapy
Timepoint
before intervention-3month after intervention-6 month after intervention
Method of measurement
Interview

Intervention groups

1

Description
Receiving 18-21g of oral supplement oil, (Cannabis Sativa L,Oenothera Biennis L), daily and advising diet with hot nature for 180 days.
Category
Treatment - Drugs

2

Description
Receiving 18-21g of oral supplement oil (Cannabis Sativa L,Oenothera Biennis L), daily for 180 days.
Category
Treatment - Drugs

3

Description
Receiving daily 18-21g of "Olive Oil" as placebo for 180 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurosciences Research Center (NSRC)
Full name of responsible person
Dr Mehdi Farhoudi
Street address
Imam Reza Medical Center-Neuro Sciences Research Center
City
Tabriz
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Formally, Traditional Medicine Center of Yashil Daroye Sahand Company cut off its support and Neuros
Full name of responsible person
Soheila Rezapour Firouzi
Street address
17 shahrivar Aveneue, In front of Farhangian Clinic
City
Tabriz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neurosciences Research Center (NSRC)
Full name of responsible person
Dr Mehdi Farhoudi
Street address
Imam Reza Medical Center- Neurosciences Research Center
City
Tabriz
Country
Iran (Islamic Republic of)
Grant name
مرکز تحقیقات علوم اعصاب
Grant code / Reference number
89-2
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurosciences Research Center (NSRC)
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Soheila Rezapour-Firouzi
Full name of responsible person
Soheila Rezapour-Firouzi
Street address
Food and Drug Organization
City
Tabriz
Country
Iran (Islamic Republic of)
Grant name
بودجه شخصی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Soheila Rezapour-Firouzi
Proportion provided by this source
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
Nutrition and Health Faculty
Full name of responsible person
Dr Seyed Rafi Aref Hosseini
Position
PhD of Biochemistry & Nutrition
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Country
Iran (Islamic Republic of)
Postal code
5166614711
Phone
00984113848757-00984113357580-3
Fax
+98 41 1334 0634
Email
arefhosseinir@tbzmed.ac.ir, srarefhosseini@gmail.com
Web page address
http://tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Food & Drug Organization
Full name of responsible person
Soheila Rezapour Firouzi
Position
MSC of Nutrition, student
Other areas of specialty/work
Street address
Food & Drug Organization, Tabriz University of Medical Sciences,
City
Tabriz
Country
Iran (Islamic Republic of)
Postal code
5197617151
Phone
00984114760674-00984114421476
Fax
00984114424445-00984114422438
Email
s.rfirozi@gmail.com
Web page address
www.fdo.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Food & Drug Organization
Full name of responsible person
Soheila Rezapour Firouzi
Position
MSC of Nutrition, student
Other areas of specialty/work
Street address
Food & Drug Organization, Tabriz University of Medical Sciences
City
Tabriz
Country
Iran (Islamic Republic of)
Postal code
5197617151
Phone
00984114421476-00984114760674
Fax
00984114424445-00984114422438
Email
s.rfirozi@gmail.com
Web page address
fdo.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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