Effect of topical products extracted from essential oils of Capsicum, Apium graveolen and Menth plants on the pain intensity in patients with skeletal inflammatory pain
Determine the efficacy of Red pepper extract and Celery and Vinegar, on Skeletal Inflamatory pain
Design
First, 3 groups with the names (red pepper group) and (mint and celery essential oil group) and (mint, celery and red pepper essential oil combination group) were written on paper and placed in a container so that the mentioned number is hidden.Then, each referring patient drew a piece of paper from inside the container and was placed in his / her group. This work continued until reaching the desired sample size(60).
Settings and conduct
Study in Yahya Nejad Hospital, Babol, the orthopedic surgeon's will be conducted with specified conditions, and the entry and exit criteria will be performed, and the placement will be blinded in 3 groups
Participants/Inclusion and exclusion criteria
In this study include criteria were , patients 40 – 70 years , without other bone diseases, pregnancy and breastfeeding, the lack of drug interactions. Exclude criteria were, use of other topical analgesics.
Intervention groups
The first intervention group received Capex ointment (Red pepper), The second group receiving the solution received the CM (Celery and Vinegar), The third group received the intervention received the combination of Red pepper and Celery and Vinegar
Main outcome variables
pain reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180827040884N1
Registration date:2020-08-20, 1399/05/30
Registration timing:retrospective
Last update:2020-08-20, 1399/05/30
Update count:0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Fatemeh Taghlili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3239 9079
Email address
fa_taghlili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Effect of topical products extracted from essential oils of Capsicum, Apium graveolen and Menth plants on the pain intensity in patients with skeletal inflammatory pain
Public title
Effect of topical products extracted from essential oils of Capsicum, Apium graveolens and Mentha plants on the pain intensity in patients with skeletal inflammatory pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 40 – 70 years
without other bone diseases
Dont pregnancy and breastfeeding
The lack of drug interactions
Exclusion criteria:
Use of other topical analgesics
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, each patient referred to the clinic was given a special code. All the codes were placed in a container. Then, three envelopes named (A), (B), (C) were selected and given to patients as a blind strain.Then, by drawing lots from the patient code container, a piece of paper was taken out and the desired code was selected from one of the envelopes and the desired intervention group was identified. After the intervention group was identified, the specified code was returned to the code container. So that all participants have an equal chance to choose the intervention group. This work continued until reaching the desired sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drug was delivered to patients with identical tubes that had only a specific code
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Babol
Measurment of pain before intervention and 14 and 30 days after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
The drug was delivered to patients with identical tubes that had only a specific code, and it was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage.First intervention group received a solution by the name of the CM(Mint and Celery )which was prepared Barij Essence Pharmaceutical Company.
Category
Rehabilitation
2
Description
The second intervention group received Capex ointment which was prepared Barij Essence Pharmaceutical Company. It was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage.
Category
Rehabilitation
3
Description
The third intervention group received, combined solution( Capex ointment and CM) which was prepared Barij Essence Pharmaceutical Company. It was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad hospital
Full name of responsible person
Fatemeh taghlili
Street address
Modarres Ave.,Yahyanejad hospital., Babol
City
Babol
Province
Mazandaran
Postal code
4715763561
Phone
+98 11 3222 3594
Email
yahyanejad@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza changizi
Street address
Gorgi Abad., Islamic Azad University of Babol
City
Babol
Province
Mazandaran
Postal code
4715763561
Phone
+98 11 3241 5061
Email
info@baboliau.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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh taghlili
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gorgiabad., Islamic Azad University of Babol
City
Babol
Province
Mazandaran
Postal code
4715763561
Phone
+98 11 3241 5163
Email
fa_taghlili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Taghlili
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gorgiabad., Islamic Azad University of Babol
City
Babol
Province
Mazandaran
Postal code
4715763561
Phone
+98 11 3241 5163
Email
fa_taghlili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Taghlili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gorgi Abad., Islamic Azad University of Babol
City
Babol
Province
Mazandaran
Postal code
5715763561
Phone
+98 11 3241 5163
Email
Fa_taghlili@yahoo.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
No more information
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the study has been completed and the results of the intervention have been obtained, the impact of the intervention will be published as a paper and will be available to interested parties.
When the data will become available and for how long
Start the access period 6 months after publishing
To whom data/document is available
Health and medical professionals
Under which criteria data/document could be used
Only the information results will be provided to those specializing in the field. Statistical information will be limited to the items mentioned in the article.
From where data/document is obtainable
f_taghlili@yahoo.com
What processes are involved for a request to access data/document
After communicating through the e-mail address and the topic related to the research, and the reason for the request, the results will be presented.