Effect of local cannabinoid administration on knee osteoarthritis: A randomized triple-blind placebo based clinical trial
Design
Clinical trial with placebo group, with parallel groups, three blinded, randomized, phase 2-3 on 50 patients. Random allocation software was used for randomization.
Settings and conduct
A three-blind clinical trial study in which an equal number of knee osteoarthritis patients referred to Waliasr Hospital in Arak were randomly divided into two groups and subjected to intervention with one of placebo treatments or cannabinoid cream. Before the start of the intervention, to know the initial condition of the patients, they are asked to answer the questions of the WOMAC questionnaire (individuals must stop taking other pain-relieving drugs for a week to ten days). Then, after starting the study and receiving the drugs, the patients fill the questionnaire again 12 weeks later. The study is triple-blind, and the researchers and analyzing patients do not know about the allocation of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients over 18 years of age referred to the orthopedic clinic of Waliasr Hospital in Arak with complaints of pain caused by knee osteoarthritis and completed the written consent to participate in the study.
Intervention groups
Intervention: Cannabinoid receiving group
Control: placebo recipient
Main outcome variables
Pain, Joint stiffness, Restriction of movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221218056851N2
Registration date:2023-12-03, 1402/09/12
Registration timing:registered_while_recruiting
Last update:2023-12-03, 1402/09/12
Update count:0
Registration date
2023-12-03, 1402/09/12
Registrant information
Name
Mona hamedi tabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
hamedimona.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local cannabinoid administration on knee osteoarthritis: A randomized triple-blind placebo based clinical trial
Public title
Effect of local cannabinoid administration on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age referred to the orthopedic clinic of Valiasr Arak Hospital with complaints of knee osteoarthritis pain.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
To divide the patients into two groups A and B, the Restricted Randomization method was used according to the Random Allocation Rule. In this method, which is done using the random allocation software, 50 patients from They are numbered up to 50 and are divided into two groups A and B by the software. One group (group A) receives the placebo and group B receives the cream containing cannabinoids.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a three-blind study, a statistician who randomly places the patients in two groups receiving placebo and convert, without knowing the contents of the creams, he provides them to the patients.
The researchers will be unaware of the grouping as well as the drugs that each group receives.
Patients will also be unaware of the medicine they receive.
In addition, the cream that is used as a placebo is completely similar to the cream containing cannabinoids in terms of appearance (color, smell, concentration, etc.) and packaging, and is indistinguishable for patients. Also, the researchers are not aware of how the drugs are distributed among the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Arak University of Medical Sciences
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
IR.ARAKMU.REC.1402.159
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
immediately and 12 weeks after
Method of measurement
WOMAC (Western ontario and mcmaster universities index) questionnaire
2
Description
Joint stiffness
Timepoint
immediately and 12 weeks after
Method of measurement
WOMAC questionnaire
3
Description
Limitation of movement
Timepoint
immediately and 12 weeks after
Method of measurement
WOMAC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Canvert cream is produced according to the order of Alasht Pharmed Company in Mon Rogin Company in Iran, Alborz Province and contains cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: In the control group, a placebo is used. The placebo is also produced by Alasht Pharmed Company in Monrogin Company in Iran, Alborz Province, and has the same ingredients as Convert Cream, but does not contain cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mohammad Reza Bozorgmanesh
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
ِDr Davoud Hekmat Pou
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mona Hamedi Tabar
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hamedimona.1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mona Hamedi Tabar
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hamedimona.1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mona Hamedi Tabar
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hamedimona.1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available