The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study
The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 81 patients, for randomization a random number table was used
Settings and conduct
Clinical trial will be performed in 1401 on osteoarthritis patients referred to the Rheumatology Clinic of Rafsanjan. Patients will be evaluated at the beginning of the study and one and two months after the intervention using the Visual Analogue Scale (VAS) and the WOMAC index. Since the study is double-blind, the evaluation of clinical symptoms is performed by a rheumatologist who is not aware of the type of drug used by each individual.
Participants/Inclusion and exclusion criteria
Inclusion:Age 45-70 years, informed consent to participate in the study, moderate to severe pain intensity visual linear scale of pain, diagnosis of knee osteoarthritis based on the American College of Rheumatology diagnostic criteria and confirmation of rheumatologist diagnosis by rheumatologist, moderate pain In the knee within 24 hours on a linear-visual scale pain between 4-7 cm
Intervention groups
Participants will be divided into three groups: group 1 (27 people) using achillea millefolium oil, group 2 (27 people) placebo and group 3 (27 people) receiving Piroxicam gel.
Main outcome variables
Pain and status of osteoarthritis range of motion, morning dryness and physical function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040759N3
Registration date:2022-06-19, 1401/03/29
Registration timing:prospective
Last update:2022-06-19, 1401/03/29
Update count:0
Registration date
2022-06-19, 1401/03/29
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
2022-07-01, 1401/04/10
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study
Public title
The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Awareness consent to participate in the study
Moderate to severe pain intensity visual linear scale of pain
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:
Reluctance to continue participating in the study
Non-compliance with the study protocol
Observe any side effects that the patient thinks were caused by yarrow oil after the start of the study
Taking vitamin, mineral or other nutritional supplements and taking painkillers
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:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers, they are randomly divided into one of three groups: the treatment group (receiving achillea millefolium oil (Oil Seed Company)), the control group (paraffin) and the receiving group of piroxicam gel.
Blinding (investigator's opinion)
Double blinded
Blinding description
Controlled double-blinds (patient not knowing about and completing evaluation of checklists of the type of drug used) will be performed.The duration of the massage is 3 to 5 minutes daily and the duration of taking the medicine is 2 months.The drugs are coded by someone other than the investigator and will be delivered to the Physician. Clinical examinations and confirmation of the disease are performed by a rheumatologist and subsequent evaluations are performed under the supervision of a rheumatologist and by an internal resident who will be unaware of the groups.
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
2022-04-13, 1401/01/24
Ethics committee reference number
IR.RUMS.REC.1401.012
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 (two months after the beginning of the study)
Method of measurement
Visual Analogue Scale (VAS) And WOMAC index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 (27 Individuals) will use achillea millefolium oil. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed
Category
Treatment - Drugs
2
Description
Control group: Group 2 (Placebo) (27 individuals). The form and type of the drug is the same. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed
Category
Placebo
3
Description
Intervention group: Group 3 will receive Piroxicam gel. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed.
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
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
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
Fax
+98 34 3428 0185
Email
gh.bazmandegan@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Ali Ave, rafsanjan university of medical sciense
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Fax
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 sciense
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Fax
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Rheumatology
Street address
Emam Ali Ave, rafsanjan university of medical sciense
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0040
Fax
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