Determining the local effect of caraway oil on some clinical symptoms of knee osteoarthritis: a double-blind clinical trial study.
Design
The study is a parallel- groups, randomized, double-blind, and controlled clinical trial. Phase 3 on 50 patients in three groups.
Settings and conduct
A clinical trial will be conducted in 2019 on osteoarthritis patients referred to the rheumatology clinic in Rafsanjan. Diagnosis is made by the American College of Rheumatology. The pain level of the patients will be evaluated at the beginning and end of the study with the help of a visual analogue scale (VAS). This criterion is a 10 cm ruler that the patient is asked to indicate the intensity of his pain from 0 to 10. WOMAC (Western Ontario and Mc Master) criteria will be used to check the performance of patients.
Participants/Inclusion and exclusion criteria
All patients with osteoarthritis between the ages of 50-70. Inclusion: The diagnosis of knee osteoarthritis is based on the the American College of Rheumatology. Average knee pain during 24 hours based on the linear-visual pain scale (VAS) 4-7 cm. Exclusion: Patients suffering from inflammatory diseases and cancer, liver or kidney failure, Taking oral corticosteroids during the last 4 weeks, corticosteroids injection in the last 6 months. fever, Consuming medicinal plants , Allergy to the Pistacia Atlantica, unwillingness to continue in the study, Failure to comply with the study protocol, Side effects may be caused by Pistacia Atlantica by oil.
Intervention groups
Intervention group A: Group A will use piroxicam gel topically.
Intervention group B: Group B will use topical Pistacia Atlantica oil to relieve pain.
Control group: In group C, paraffin will be used for placebo and to compare their effects
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:IRCT20190128042525N7
Registration date:2024-11-01, 1403/08/11
Registration timing:registered_while_recruiting
Last update:2024-11-01, 1403/08/11
Update count:0
Registration date
2024-11-01, 1403/08/11
Registrant information
Name
Gholamreza Bazmandegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0185
Email address
clinical.research@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Topical Pistacia Atlantica Oil on some Clinical of Knee Osteoarthritis: a Randomized and Double Blind Clinical Trial
Public title
Effect of Topical Pistacia Atlantica Oil on some Clinical symptoms of Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50-70
The diagnosis of knee osteoarthritis is based on the criteria of the American College of Rheumatology, which is confirmed by a rheumatology specialist.
The presence of average knee pain during 24 hours based on the linear-visual pain scale (VAS) between 4 and 7 cm.
Exclusion criteria:
Patients suffering from inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.)
Cancer or serious diseases, symptoms or history of liver or kidney failure,
Taking oral corticosteroids during the last 4 weeks
corticosteroids injection in the last 6 months.
fever
Consuming medicinal plants continuously
Allergy to the Pistacia Atlantica
unwillingness to continue participating in the stud
Failure to comply with the study protocol
Observing any side effects that the patient thinks are caused Pistacia Atlantica by oil.
Age
From 50 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to reduce bias and increase the reliability of the results, patients were assigned to three groups using a table of random numbers. In this way, the researcher first considered the direction of reading the numbers as a left-to-right convention. Then he assigned numbers 00-30 to group A, numbers 31-60 to group B, and numbers 61-90 to group C. Then the researcher put his hand on one of the numbers and recorded the numbers from left to right and assigned them to different groups. To hide the random allocation (allocation concealment), drugs and placebo were placed in the same packages and coded as A, B, and C. In the randomization process, the person involved in creating the randomization plan was separate from other researchers, to reduce possible bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the study, the drugs will be placed in the same packages by someone other than the researcher and coded as A, B, and C. Medicines are prescribed by a rheumatology specialist in the form of medicine A or B or C and the medicine is delivered by another person. The evaluation of clinical symptoms is done by the internal resident, who does not know the type of medicine used by each person, and based on the relevant protocol (which is explained below).
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 Abitaleb Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.RUMS.REC.1398.143
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)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Group A will use piroxicam gel topically. The duration of treatment is 3 months and twice a day. In addition, patients will be allowed to use oral analgesics drugs as needed to relieve their pain.
Category
Treatment - Drugs
2
Description
Intervention group B: Group B will use topical Pistacia Atlantica oil to relieve pain. The duration of treatment is 3 months and twice a day. During the study, patients are only allowed to use oral painkillers once a day if needed, and none of the common drugs will be used during this period.
Category
Treatment - Drugs
3
Description
Control group: In group C, paraffin will be used for placebo and to compare their effects.The duration of treatment is 3 months and twice a day. During the study, patients are only allowed to use oral painkillers once a day if needed, and none of the common drugs will be used during this period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Gholamreza Bazmandegan
Street address
Modares Street, Clinic Modares
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
No. 3و Imam Ali Blvd., Central Organization, Rafsanjan,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0185
Email
clinical.research@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
Gholamreza Bazmandegan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physiology-Pharmacology
Street address
Ali Ibn_Taleb Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zahra Kamiab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Fars Gulf Blvd - Pistachio Blvd - University of Medical Sciences Campus - Faculty of Medicine
City
Rafsanjan
Province
Kerman
Postal code
37718175911
Phone
+98 34 3428 0185
Email
dr.kamiab89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Gholamreza Bazmandegan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physiology-Pharmacology
Street address
Ali Ibn-Abitalb blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
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