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IRCT20200408046986N1 IRCT 2020-05-03 Yasdaru pharmaceuticals Safety and effectiveness of Satinex buccal spray Safety and effectiveness of Satinex buccal spray for improving quality of life in multiple sclerosis patients 2020-05-21 anticipated 60 Complete https://irct.ir/trial/46998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization method, randomized via "www.sealedenvelope.com" application; blind allocation (concealed allocation type) which means that the person allocating the participant to a group is blinded to which group (treament or control) they are allocating them to, Blinding description: In this study patient taking drug, and the doctor who diagnoses the patients and measures outcomes, is kept blind while the researcher who analyzes the outcomes is completely aware of the circumstances. 2 Multiple Sclerosis. 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 single 100 microliter spray , other ingredients (as exepients : ethanol, propylene glycol, peppermint), Manufacturer: YASDAROU company, route of administration: buccal spray. Intervention 2: Control group: Placebo spray (containing every ingredient in Satinex but API : ethanol, propylene glycol, peppermint oil). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is none
public Saeed shahbeigi
No. 24, Komijani St., Hafthowz Sq., Tehran , Iran
Tehran Iran (Islamic Republic of) 1648894833 +98 21 7795 7666 s_shahbeigi@yahoo.com Islamic Azad University scientific Saeed shahbeigi
No. 24 (Dr Shahbeigi neurology clinic) , Komijani St., Hafthowz Sq., Tehran , Iran
Tehran Iran (Islamic Republic of) 1648894833 +98 21 7797 1512 s_shahbeigi@yahoo.com Islamic Azad University Iran (Islamic Republic of) 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 18 years 60 years Both 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 G35 Multiple sclerosis Treatment - Drugs Placebo 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 single 100 microliter spray , other ingredients (as exepients : ethanol, propylene glycol, peppermint), Manufacturer: YASDAROU company, route of administration: buccal spray Control group: Placebo spray (containing every ingredient in Satinex but API : ethanol, propylene glycol, peppermint oil) 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). YAS DARU Approved 2019-11-20 Ethics committee of Azad univesity of Medical Science No 16, Azad university of medical science institutional block, western Goleyakh alley, Ayeneh Blvd., Pabarja Ave., Shariati St. Tehran Tehran Iran (Islamic Republic of)