Determining the effect of using kharatin oil on improving spasticity in patients with neurological disorders
Design
A clinical trial with a control group, with parallel groups, one-way, blind, randomized, on 50 patients, used the random function of Excel software rand for randomization.
Settings and conduct
This study is a pilot and one-way blind clinical trial.The study was performed on 50 patients with spasticity disorder who are hospitalized in the neurology ward. For three months, topical treatment with kharatin oil and the control group are treated with paraffin oil during the same period. The patient is also blind to being in the drug or placebo group.
Participants/Inclusion and exclusion criteria
Existence spasticity disorder- Sensitivity to kharatin oil
Intervention groups
50 people are included in the study as a pilot and after collecting the complete statistical population by drawing 25 people in the intervention group (patients with spasticity Treatment with kharatin oil) and the remaining 25 patients in the control group (patients with spasticity treated with paraffin oil).
Main outcome variables
Quality of Life,paraletic limb function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210806052093N1
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Mona Arab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 2152
Email address
m_arab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of application of kharatin oil on the improvement of spasticity of patients with neurological disorders
Public title
The effect of kharatin oil on improving limb stiffness in patients with neurological disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of spasticity disorder
Exclusion criteria:
Sensitivity to kharatin oil
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant is blind.The drug and placebo are randomly distributed and recorded among the participants without a label and in identical envelopes by the project partner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of kerman university of medical sciences
Paralysis performance score in modified ashworth scale questionnair
Timepoint
At the beginning of the study and 3 months after starting to use kharatin oil and paraffin
Method of measurement
modified ashworth scale questionnair
Secondary outcomes
1
Description
Quality of life score
Timepoint
At the beginning of the study and 3 months after consuming kharatin oil and paraffin
Method of measurement
World Health Organization Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group:25 people in the intervention group who have spasticity disorder are treated topically with standard Aral kharatin oil made in Iran for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of kharatin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed.
Category
Treatment - Drugs
2
Description
Control group: 25 people in the control group who have spasticity disorder are treated topically with paraffin oil for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of paraffin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Hossein Ali Ebrahimi
Street address
Kowsar Blvd, Shafa Hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
hebrahimi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Haft Bagh Alavi Blv,Campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3132 5041
Email
abpardakhty@kmu.ac.ir
Web page address
Grant name
Vice Chancellor for Research and Technology of Kerman University of Medical Sciences
Grant code / Reference number
411389339391
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mona Arab
Position
neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Kowsar Blvd, Shafa Hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
monaarb68@gmail .com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rostam Seifaddini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Kowsar Blvd-Shafa Hospital
City
کرمان
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
r.seifaddini @gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mona Arab
Position
Neurolgy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Kowsar Blvd-Shafa Hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
Monaarb68@gamil.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
The results of extracting the modified ashworth scale questionnaire about the subjects can be shared after identifying the subjects.
When the data will become available and for how long
After taking medication and placebo and completing the modified ashworth scale questionnaire
To whom data/document is available
Faculty members of medical universities throughout Iran
Under which criteria data/document could be used
With a written request to reuse the files
From where data/document is obtainable
Postal address: Kerman, Kowsar Blvd., Shafa Hospital, Mona Arab E-mail address: Monaarb68@gmail.com Phone number: 09131435195
What processes are involved for a request to access data/document
The written and official request of the applicant, which has been approved by the Vice Chancellor for Research of the University of the applicant's place of work, will be sent within one week at the latest.