Effect of lavender oil on some clinical symptoms of patients with knee osteoarthritis referred to the rheumatology clinic : a double blind randomised control trial
Determining the effect of lavender oil on a number of clinical symptoms of knee osteoarthritis patients who referred to the rheumatology clinic of Ali Bin Abi Taleb Hospital in Rafsanjan in 2023
Design
Clinical trial with control group and double-blind with simple randomization method, phase 3 on 105 patients.
Settings and conduct
A clinical trial will be conducted in 1401 on osteoarthritis patients referring to the rheumatology clinic of Rafsanjan city. Diagnosis is made by the American College of Rheumatology. The amount of pain, morning dryness, range of motion and performance of patients in all three intervention groups at the beginning and end of the study, with the help of (VAS) and (WOMAC). Double blind Clinical symptoms are assessed by a rheumatologist who is not aware of the type of medication used by each individual.
Participants/Inclusion and exclusion criteria
Age 45-70 years, the diagnosis of osteoarthritis of the knee is based on the diagnostic criteria of the ACR and the rheumatologist's diagnosis, existence of moderate pain in the knee during 24 hours based on the linear-visual scale of pain between 4-7 cm, Allergy to lavender Reluctance to continue participating in the study Non-compliance with the study protocol Observing any side effects caused by lavender in the patient's opinion
Intervention groups
The participants are divided into three groups of 35 people A, B and C. In group A prepared paraffin oil without effect (placebo group), in group B lavender oil (intervention group) and in group C piroxicam gel (control group). The duration of the treatment is one month and the medicine is used topically once a day.
Main outcome variables
Pain and status of osteoarthritis in terms of morning stiffness, range of motion and function of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040759N4
Registration date:2023-03-30, 1402/01/10
Registration timing:prospective
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Mitra Abbasifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0040
Email address
dr.mabbasifard@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lavender oil on some clinical symptoms of patients with knee osteoarthritis referred to the rheumatology clinic : a double blind randomised control trial
Public title
Effect of lavender oil on some clinical symptoms of patients with knee osteoarthritis referred to the rheumatology clinic : a double blind randomised control trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-70 years
The diagnosis of osteoarthritis of the knee is based on the diagnostic criteria of the American College of Rheumatology and the confirmation of the rheumatologist's diagnosis by a rheumatologist
Existence of moderate pain in the knee during 24 hours based on the linear-visual scale of pain between 4-7 cm
Exclusion criteria:
Allergy to lavender
Reluctance to continue participating in the study
Non-compliance with the study protocol
Observing any side effects caused by lavender in the patient's opinion
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into three groups of 35 people, A, B, and C, using a simple randomization method (random number table). In group A, prepared paraffin oil without effect (placebo group), in group B, topical lavender oil (intervention group) and in group C, piroxicam gel (control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to make the study double-blind, before the start of the study, the drugs are coded by someone other than the evaluator (secretary). Drug grouping and prescription is done by the rheumatology subspecialist in the form of drug A or B or C and drug delivery is done by another person (secretary). In addition, the analyzer is unaware of the grouping method and the drug used (double blind). In the placebo group, Paraffin oil, which is a ready-made pharmaceutical base without any effect, is used along with a color similar to lavender for placebo. The color of drug and placebo and the vials containing them are completely similar.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-02-20, 1401/12/01
Ethics committee reference number
IR.RUMS.REC.1401.225
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain intensity
Timepoint
At the beginning and the end of the study (three months after the beginning of the study)
Method of measurement
Visual Analogue Scale (VAS) And WOMAC index
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Group A (35 people) of prepared paraffin oil and without effect (placebo group), the form and type of medicine are the same. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients in all groups were only allowed to use non-anti-inflammatory oral pain relievers (such as Meloxifar 7.5 mg tablets) once a day as needed.
Category
Placebo
2
Description
Intervention group: group B (35 people) topical lavender oil will be used. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients are only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day in all groups if needed.
Category
Treatment - Drugs
3
Description
Intervention group: Group C (35 people) uses piroxicam gel (control group). The duration of the treatment is one month and the medicine is used topically once a day. The duration and amount of daily drug use are the same in the groups. During the study, patients were only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day throughout
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Street address
Emam Ali Ave, rafsanjan university of medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Email
dr.mabbasifard@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Bazmandegan
Street address
Imam Ali Street, Central Authority
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
gh.bazmandegan@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emam Ali Ave, rafsanjan university of medical sciences
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Email
dr.mabbasifard@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emam Ali Ave, rafsanjan university of medical sciences
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Email
dr.mabbasifard@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emam Ali Ave, rafsanjan university of medical sciences
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Email
dr.mabbasifard@rums.ac.ir
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