The present project was conducted with the aim of investigating the effect of the product containing chamomile oil (Matricaria Chamonail) and mineral salt on the clinical symptoms of moderate and mild knee osteoarthritis.
Design
A double-blind, randomized clinical trial with a phase 3 control group on 224 patients with knee OA, which is conducted using a randomized block method and based on a randomization list prepared with R software.
Settings and conduct
A double-blind clinical trial of 224 patients with OA in hospitals affiliated to Shahid Sadougi University of Medical Sciences, Yazd, who were divided into intervention and control groups by random block method and based on the randomization list. 3 weeks and three times a day around the knee after training, it is massaged by the patient. All drugs are in the same package and coded by the pharmacist.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include the following:
All patients aged 30 to 70 years with moderate and mild knee OA according to the womac criteria
The main conditions for not entering the study:
The presence of lesions and skin diseases in the knee, patients with known rheumatic diseases or gout, People with local vascular diseases, severe deformity and bone structural disorders, history of knee joint replacement or intra-articular drug injection or knee joint surgery, history of previous intra-articular fracture based on patient self-report, overweight with BMI higher than 35
Intervention groups
In the intervention group, combined chamomile oil (including chamomile extract in Sesame oil + mineral salt) and in the control group,Sesame oil is used for 3 weeks and three times a day. The method of use is taught to the patient by the doctor at the first visit. Every time , a few drops of oil are poured around the knee and all areas are well massaged
Main outcome variables
Pain; WOMAC score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240709062374N1
Registration date:2024-08-21, 1403/05/31
Registration timing:registered_while_recruiting
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
roghayeh zare
Name of organization / entity
Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 352 9758
Email address
r.zare@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Matriarchal chamomile oil and mineral salt product on the clinical symptoms of knee osteoarthritis
Public title
The effect of combined chamomile oil in the treatment of knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 30 to 70 years with moderate and mild knee OA according to WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) criteria
Exclusion criteria:
The presence of lesions or skin diseases around the knee
Patients with known rheumatic diseases or gout
People with local vascular diseases
Severe deformity and bone structural disorders
History of knee joint replacement or intra-articular drug injection or knee joint surgery
History of previous intra-articular fracture based on patient self-report
Overweight with a BMI higher than 35
People who are not able to visit every week for follow-up treatment
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
224
Randomization (investigator's opinion)
Randomized
Randomization description
Random block (28 blocks of 8) based on the randomization list prepared by R software.In order to blind the researcher and the patient to the type of drug used, the oils are coded in the same containers by the pharmacist and delivered to the researcher at the beginning of the study.All drugs are coded and given to the patient based on randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the researcher and the patient to the type of drug used, the oils are coded in the same containers by the pharmacist and delivered to the researcher at the beginning of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Shahid Sadougi University of Medical Sciences, Yazd
Street address
Shahid Sadougi University of Medical Sciences - Shahid Sadougi Medical Sciences Blvd. - Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403.016
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
Pain score
Timepoint
The beginning of the study, 7, 14 and 21 days after the start of the study
Method of measurement
Visual Analog Scale
2
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint
The beginning of the study, 7, 14 and 21 days after the start of the study
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, combined chamomile oil (including chamomile extract in Sesame oil + mineral salt) and in the control group, Liquid paraffin is used for 3 weeks and three times a day. The method of use is taught to the patient by the doctor at the first visit. can be done Every time a few drops of oil are poured around the knee and all areas are used well. The medicine used, the oils are consumed in the same containers by the pharmacist and delivered to the primary researcher of the study code.
Category
Treatment - Drugs
2
Description
Control group: The control group of Liquid paraffin is used for 3 weeks and three times a day. The method of use is taught to the patient at the first visit by the doctor, and it is in this way that every time a few drops of oil are poured around the knee and all areas are All patients are followed up by telephone to emphasize the continuous use of the drug and obtain reports of possible side effects. In order to blind the researcher and the patient to the type of drug used, the oils are coded in the same containers by the pharmacist and given to the researcher. It is delivered at the beginning of the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardakan Faculty of Traditional Persian Medicine
Full name of responsible person
Roghayeh Zare
Street address
Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8916693649
Phone
+98 35 3323 8917
Email
drzare313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Amin Salehi Abargoui
Street address
Imam Reza Research Educational Complex, Daneshjo Boulevard
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd
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
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Roghayeh Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8916693649
Phone
+98 913 352 9758
Email
drzare313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Roghayeh Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8916693649
Phone
+98 913 352 9758
Email
drzare313@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Roghayeh Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Imam Khomeini St.
City
Ardakan
Province
Yazd
Postal code
8916693649
Phone
+98 913 352 9758
Email
drzare313@gmail.com
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