1) Determining the effect of neurocid herbal medicine on improving the clinical symptoms of patients with MS
2) Determining the effect of neurocid herbal medicine on the paraclinical changes of MS patients in MRI imaging
Determining the effect of neurocid herbal medicine on the Cytokan such as: IL-1β; IL-6; TNF-α; IL-4; TGF-β and cell line CellTox Green Cytotoxicity assay (Promega cat.# G8741)
9) Determining the effect of neurocid herbal medicine on the paraclinical changes of MS patients in the quality of life
Design
A clinical trial, with a control group, with parallel groups, single-blind, randomized, phase 2 for 30 patients.
Settings and conduct
Patients referred to the hospital clinic on 22 Bahman.
Blinding for laboratory personnel and laboratory tests is defined); How to blind with randomizer research site
Participants/Inclusion and exclusion criteria
Age more than 20 years; Having MS; not pregnant
Intervention groups
The case group includes 30 patients with MS referred and admitted to 22 Bahman hospital in Mashhad, whose clinical examinations and results by specialist doctors have confirmed multiple sclerosis in them, are included in the study, and the herbal drug Neurocid together with standard drugs.
The control group consists of 30 patients with multiple sclerosis referred and admitted to 22 Bahman Hospital in Mashhad, who receive the selected multiple sclerosis drug along with placebo under the same conditions.
Main outcome variables
Clinical signs; paraclinical symptoms; Changes in inflammatory cytokines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231030059908N3
Registration date:2024-06-21, 1403/04/01
Registration timing:retrospective
Last update:2024-06-21, 1403/04/01
Update count:0
Registration date
2024-06-21, 1403/04/01
Registrant information
Name
Fateme Mollazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 4944
Email address
f.mollazade1159@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-25, 1399/08/04
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
2020-10-25, 1399/08/04
Actual recruitment end date
2021-03-21, 1400/01/01
Trial completion date
2021-10-26, 1400/08/04
Scientific title
Effect of norosid medicine on Clinical findings in patients with multiple sclerosis.
Public title
Effect of norosid medicine on Clinical findings in patients with multiple sclerosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with MS (multiple sclerosis).
Age more than 20 years.
Exclusion criteria:
Patients who are very old or have very severe and old complications of MS, including severe and old muscle atrophy or ankylosis or severe joint deformity.
Pregnant women
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the randomizer research site at https://www.randomizer.org/, we randomly assign 60 codes to 2 groups of neurocidal drug and placebo. Medicines are all in the form of capsules with the same shape, size, color and packaging but different codes
Blinding (investigator's opinion)
Single blinded
Blinding description
This design is one-way blind (defined for laboratory personnel and laboratory tests) and it is necessary for the treating doctors to be aware of the grouping of patients in order to stop prescribing the NBS combination in case of possible disturbance in the natural course of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, Islamic Azad University, Mashhad Branch
Street address
No.14; Imam Khomeini Street; Faculty of Medicine; Azad University; Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.IAU.MSHD.REC.1399.156
Health conditions studied
1
Description of health condition studied
Moltiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical symptom improvement percentage
Timepoint
Before the start of the intervention and three months after the start of the project.
Method of measurement
Based on the observation of the specialist doctor or the patient's own statements
2
Description
Paraclinical changes
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Doing an MRI
3
Description
Changes in inflammatory cytokines
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Along with the standard treatment of MS, they will take neurocid medicine at a dose of 500 mg every 12 hours for a period of 3 months.
Category
Treatment - Drugs
2
Description
Control group: The selection will be made from the patients with MS whose disease has been confirmed by a neurologist and who are similar to the case group in terms of age, sex, and disease severity. This group will receive standard anti-MS treatment plus a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
22Bahman hospital clinic.
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Street address
No7; Kuy-e-Tollab; Mashhad town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3259 5516
Email
seyyedm43@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Seyyed Mohammad Reza Hashemizadeh
Street address
No.14 , Emam khomein Ave., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 3225 0041
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Social security of the clinic: Ghasemabad: Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9181664555
Phone
+98 51 3845 3742
Email
seyyedm43@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Social security of the clinic; Ghasemabad: Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9181664555
Phone
+98 51 3845 3742
Email
seyyedm43@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No. 2/1; Blv Pirouzi; Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176982756
Phone
+98 51 5523 4944
Fax
Email
f.mollazade1159@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