Comparison of the effect of liposomal form of pistachio kernel oil and placebo on the level of some inflammatory and anti-inflammatory agents as well as their receptors in mononuclear cells in peripheral blood and change in the severity of clinical symptoms in women with multiple sclerosis
Comparison of the effect of liposomal form of pistachio kernel oil and placebo on inflammatory and anti-inflammatory agents and their receptors in peripheral blood mononuclear cells and the severity of clinical symptoms in women with multiple sclerosis
Design
Clinical trial with control group, double-blind, simple randomized, phase 3 on 500 MS patients. Excel software rand function is used for randomization
Settings and conduct
This clinical trial will be performed on MS patients referred to Ali Ibn Abitaleb Hospital in Rafsanjan. 500 MS patients will be included in the study and will be divided into intervention and control groups and will be treated and monitored for 24 weeks with the liposomal form of 10% pistachio kernel oil or placebo. In this study, blinding is also performed. Participants, lead researcher, health care staff responsible for patient care, data collection and outcome assessors, data safety and monitoring committee, and drafters, will keep blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18 to 51 years with definitive diagnosis of multiple sclerosis and descriptive measurement of disability between 1 to 3. Exclusion criteria: using corticosteroids during study, pregnancy and lactation, autoimmune diseases, other neurological diseases.
Intervention groups
Nanoliposome intervention group: This group is given the liposomal form of 10% pistachio kernel oil orally to MS patients for 24 weeks.
Control group: This group of placebo is given orally to MS patients for 24 weeks.
Main outcome variables
Concentration of inflammatory and anti-inflammatory factors;
Relative expression of receptors genes of inflammatory and anti-inflammatory agents;
The length and severity of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201219049765N1
Registration date:2021-08-04, 1400/05/13
Registration timing:prospective
Last update:2021-08-04, 1400/05/13
Update count:0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
ali Jebali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3833 0756
Email address
alijebal2011@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-19, 1400/05/28
Expected recruitment end date
2022-08-19, 1401/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of liposomal form of pistachio kernel oil and placebo on the level of some inflammatory and anti-inflammatory agents as well as their receptors in mononuclear cells in peripheral blood and change in the severity of clinical symptoms in women with multiple sclerosis
Public title
The effect of consuming the liposomal form of pistachio kernel oil on multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 51 years
Definite diagnosis of multiple sclerosis with a descriptive measure of disability rate between 1 to 3
Exclusion criteria:
Taking corticosteroids during the study
Pregnancy and lactation
Active cardiovascular disease, liver disease, gastrointestinal disease, patients with Helicobacter pylori positive test, kidney disease, diabetes mellitus, respiratory disease and autoimmune diseases
Take multivitamin, mineral, antioxidant and pistachio kernel supplements during the 30 days before the study
Age
From 18 years old to 51 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: Simple randomization
Randomization unit: individual
Randomization tool: Excel software
How to build a random sequence: with RAND function in excel software
Allocation concealment: For allocation concealment, the method of Sequentially numbered, sealed, opaque envelopes (SNOSE) will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, lead researcher, healthcare staff responsible for patient care, data collection and outcome assessors, data safety and monitoring committee, and drafters, They will keep blind. To simulate the intervention in 2 groups, similar vials in terms of volume, shape and appearance will be used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan - Imam Ali Boulevard - Central University Organization - Postal Code: 7717933777
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.RUMS.REC.1399.184
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Concentration of inflammatory and anti-inflammatory factors
Timepoint
Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24)
Method of measurement
With ELISA Kit
2
Description
Relative expression of genes of receptors of inflammatory and anti-inflammatory agents
Timepoint
Intervention time (w0), 24 weeks after intervention (w24)
Method of measurement
By Realtime PCR
3
Description
The length and severity of the disease
Timepoint
Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24)
Method of measurement
According to the descriptive measurement of disability rate
Secondary outcomes
1
Description
Allergies to pistachio compounds
Timepoint
Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24)
Method of measurement
Qualitative examination with patient self-declaration
Intervention groups
1
Description
Intervention group: once a day, 5 ml, liposomal form of 10% pistachio kernel oil, orally, for 24 weeks. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. The liposomal form of pistachio kernel oil is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: This group will be given the same as the placebo test group with the same intervention group program. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. Pharmacopoeia is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan Ali Ibn Abitaleb Hospital
Full name of responsible person
Dr. Gholam Hossein Hassan Shahi
Street address
Rafsanjan - Mofteh Boulevard - Hazrat Ali Ibn Abitaleb Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
alijebal2011@gmail.com
Web page address
http://aliebn.rums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Gholam Hossein Hassan Shahi
Street address
Address: Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
alijebal2011@gmail.com
Web page address
http://www.rums.ac.ir/
Grant name
Grant code / Reference number
99099
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
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Gholam Hossein Hassan Shahi
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Address: Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
alijebal2011@gmail.com
Web page address
http://www.rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Jebali
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No2, Yaqut building, anbiya shomali Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915897671
Phone
+98 35 3833 0756
Fax
Email
alijebal2011@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Jebali
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No2, Yaqut building, anbiya shomali Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915897671
Phone
+98 35 3833 0756
Fax
Email
alijebal2011@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on primary and secondary outcomes will be available to researchers
When the data will become available and for how long
Infinitely after the publication of the article
To whom data/document is available
Researchers and volunteers surveyed
Under which criteria data/document could be used
For research work
From where data/document is obtainable
Responsible of the project
Gholamhossein Hasanshahi
alijebal2011@gmail.com
What processes are involved for a request to access data/document
Formal request to the university and then refer to the project manager