Evaluation of Clinical and Metabolic Responses to Combined Effect of Curcumin, Cholecalciferol, and Evening Primrose oil in Patients with Multiple Sclerosis
Determination of Clinical and Metabolic Responses to the combined Effect of Curcumin, Cholecalciferol and Olive Oil in Patients with Multiple Sclerosis
Design
Random assignment was done by the use of computer-generated random numbers. Population and sample size: In the study 60 patients with Multiple Sclerosis among males and females of eligible and referred to health and clinical centers affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, were selected.
Settings and conduct
In the study 60 patients with Multiple Sclerosis among males and females of eligible and referred to health and clinical centers affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, were selected.Patients and researchers are blind until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects with Multiple Sclerosis. Exclusion criteria: patients who did not want to cooperate; patients who had others complications such as: kidney disease؛ neuropathy and retinopathy, patients with hypo and/or hyperthyroidism and so patients with other inflammatory diseases such as allergies and autoimmune diseases, and pregnant women were excluded from this study.
Intervention groups
Patients were assigned to receive either extract (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Clinical and Metabolic Responses in Patients with Multiple Sclerosis were measured before and after of the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170430033730N6
Registration date:2019-03-25, 1398/01/05
Registration timing:prospective
Last update:2019-03-25, 1398/01/05
Update count:0
Registration date
2019-03-25, 1398/01/05
Registrant information
Name
Seyyed Mehdi Mirhashemi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
sm.mirhashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-13, 1398/01/24
Expected recruitment end date
2019-05-02, 1398/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clinical and Metabolic Responses to Combined Effect of Curcumin, Cholecalciferol, and Evening Primrose oil in Patients with Multiple Sclerosis
Public title
Effect of Curcumin, Vitamin D and herbal oil on Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with MS
Exclusion criteria:
Patients who do not want to cooperate;
Patients who have others complications such as: kidney disease؛ neuropathy and retinopathy;Patients with hypo and/or hyperthyroidism are excluded from this study.
Patients with other inflammatory conditions such as allergies and autoimmune diseases
pregnant women
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random assignment was done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo was used to blind. Researchers and Patients will be blinded by the professional analyst until final analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2019-02-21, 1397/12/02
Ethics committee reference number
IR. QUMS. REC.1397.351
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
hs-CRP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Elisa
2
Description
IL-18
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
T25FW test
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Physical examination
2
Description
9-HPT Test
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Physical examination
3
Description
FBS
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
4
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
5
Description
TG
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
6
Description
Cholesterol
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
7
Description
HDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
8
Description
LDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
9
Description
AST
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
10
Description
ALT
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
11
Description
ALKP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
12
Description
TP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
13
Description
Alb
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
14
Description
BUN
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
15
Description
کراتنین
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
16
Description
Glutathione
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
17
Description
MDA
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
18
Description
SOD
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
19
Description
NO
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Two sub-gels containing (80 mg curcumin + 1000 IUD3) and Primrose oil (1000 mg) will receive daily for twelve weeks
Category
Treatment - Drugs
2
Description
Control group: Two sub-gels of placebo were taken daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Dr Seyyed Mehdi Mirhashemi
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197 - 59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Vice Chancellor for research of Qazvin University of Medical Sciences, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197 - 59811
Phone
+98 28 3333 6001
Email
a.peymani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available