Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: Satinex spray ,chemical ingredients: delta-9-tetrahydrocannabinol or THC (2.7 milligrams in each single 100 microliter) Cannabidiol or CBD (2.5 milligram in each s
Sponsors
Yasdaru pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Written Informed consent of all patients included in the study Patients diagnosed with multiple sclerosis by a specialist Stability of patients disease since one month before the study being started Patients Disease Modifying Therapy regimen should remain the same during the study
Exclusion criteria
Exclusion criteria: A history of Schizophrenia and other serious mental morbidities (Except depression and anxiety due to MS disease) A history of substance abuse Smoking and generally using cannabis (since 30 days prior to the study starting date and disability to quit during the study ) and taking any other cannabis based medications (60 days prior to study starting date) taking Botulinum shot since 4 months prior to the study starting date a history of epilepsy and repetitive convulsions a history of MI and serious cardiac arrest acute liver and renal failure pregnancy and lactation Taking other investigational drugs elective surgeries and blood donation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Filling the MSQOL questionnaire prior to the intervention, At the end of the first, second and third month since the starting point. Method of measurement: MSQOL-54 questionnaire.;Levels of spasticity. Timepoint: At the starting point and at the end of the third month of the research. Method of measurement: Modified Ashworth Scale for grading spasticity.;Levels of pain. Timepoint: At the starting point and at the end of every week from the starting point. Method of measurement: Numerical Rating Scale.;Spasticity frequency (times per day). Timepoint: At the starting point and at the end of every week from the starting point. Method of measurement: Visual Analogue Scale.;Levels of sleep disorder due to spasticity. Timepoint: At the starting point and at the end of every week from the starting point. Method of measurement: Visual Analogue Scale.;Disease stage. Timepoint: At the starting point and at the end of the third month of the research. Method of measurement: Expanded Disability Status Scale (EDSS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed shahbeigi
Islamic Azad University
Outcome results
None listed