Evaluation of the effectiveness of Iranian traditional medicine product based on commiphora mukul on patients with osteoarthritis of the knee compared to placebo
Determining the efficacy of commiphora mukul in patients with knee osteoarthritis
Design
Clinical trial with control group with parallel group, randomized double-blind Phase 3 is over 70 patients. For randomization using a simple randomization method and will be done in a double-blind method
Settings and conduct
Eligible individuals will be randomly assigned to participate in the study randomly using simple randomization and easy sampling methods, using the two-way blind method. Drugs and placebo (35 people) The drops contain 30 ml of mimic gum and the same amount of placebo, which are exactly the same color, shape and weight and will be available in similar packages. Each patient should take 15 cc of the drops twice a day for two months and twice a day to blind the study. Before the study begins, the drops are encoded by a person other than the researcher in the same packages as A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age 40 to 70 - Knee pain(scal 4-7)
Exclusion criteria:Severe illnesses, treatment with oral corticosteroids for the past 4 weeks, corticosteroid injections for the past 6 months
Intervention groups
The intervention group includes patients who receive the commiphora mukul
The control group includes patients receiving placebo
Main outcome variables
The severity of the pain - the degree of inability to function the knee
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200225046612N1
Registration date:2020-05-01, 1399/02/12
Registration timing:prospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Aََbolghasem Mirzaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 4440
Email address
abolghasem.mirzaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Iranian traditional medicine product based on commiphora mukul on patients with osteoarthritis of the knee compared to placebo
Public title
Investigating the effect of commiphora mukul on osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 40 and 70 years old,
Diagnosis of knee osteoarthritis based on the diagnostic criteria of American College of Rheumatology and confirmation of knee osteoarthritis by a rheumatologist using radiography and kellgren lawrence criteria
The presence of moderate knee pain in the last 24 hours so that according to the Visual Analogue Scale (VAS) the pain is between 4 to 7 cm
Exclusion criteria:
.Cancer or serious illness
Symptoms or history of liver or kidney failure
Treatment with oral corticosteroids in the last 4 weeks or Corticosteroid injections in the last 6 months
fever
Consumption of any type of medicinal plant
Allergy to commiphora
Lack of willingness to continue participating in the study
Nonconformity with the study protocol
See any side effects
Lack of nutritional supplementation and painkillers
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be conducted randomly using simple randomization Based on the table of random numbers will be in one of the two groups of Intervention numbers (35 people) and placebo (35 people).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study, the droplets are encoded by a person other than the researcher in the same packages as A and B before the study begins.And all patients are asked to bring their previous drops with them in each visit. Patients and researchers are unaware of the type of medication until the end of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Research Ethics Committee
Street address
Kermanshah - Beheshti Boulevar
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-03-03, 1398/12/13
Ethics committee reference number
IR.KUMS.REC.1399.104
Health conditions studied
1
Description of health condition studied
Knee osteoartritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized osteoarthrosis
Primary outcomes
1
Description
The severity of the pain
Timepoint
Before the intervention and the next two months
Method of measurement
VAS questionnair
2
Description
Inability to function
Timepoint
Before the intervention and the next two months
Method of measurement
Koos questionnaire
3
Description
Quality of Life
Timepoint
Before the intervention and the next two months
Method of measurement
Koos questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: twice a day for two months from the extract of commiphora mukul plant, which is prepared by Badrang teb Kuhistan, affiliated to the Science and Technology Park of the Ministry of Science and Technology, according to scientific standards, under the supervision of a traditional pharmacy specialist at a dose of 15 ml.
Category
Treatment - Drugs
2
Description
Control group: Patients with a dose of 15 cc for two months are given a placebo that is similar to the intervention drug
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fattahi Clinic in Kermanshah
Full name of responsible person
Mohammad Hossein Farzaei
Street address
Building No. 1, Kermanshah University of Medical Sciences(KUMS), Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
mh.farzaei@gmail.com
2
Recruitment center
Name of recruitment center
Mahdieh Rheumatology Subspecialty Clinic
Full name of responsible person
َAlireza fazaeli
Street address
the beginning of Eram Boulevard. Shahid Beheshti Medical Center. Ghaem Square hamedan
City
Hamedan
Province
Hamadan
Postal code
9 3371-5-6517
Phone
+98 81 3838 0283
Fax
+98 81 3838 1035
Email
dr.alifazaeli@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd. - nomber2 Building of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Fax
+98 83 3837 0541
Email
farid_n32@yahoo.com
Web page address
Grant name
Research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mirzaie abolghasem
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
- Shahid Shiroudi Boulevard - Daneshgah Street - Nurse Boulevard - Faculty of Pharmac
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
0098838214440
Fax
+98 83 3427 6493
Email
abolghasem.mirzaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farzaei mohammad hossain
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Shiroodi Boulevard - Daneshgah Street - Nurse Boulevard - School of Pharmacy
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Fax
+98 83 3427 6493
Email
mh.farzaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mirzaie abolghasem
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Shiroodi Boulevard - Daneshgah Street - Nurse Boulevard - School of Pharmacy
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 81 3821 4440
Email
abolghasem.mirzaie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
6 months after printing
To whom data/document is available
University and industrial institutions
Under which criteria data/document could be used
Treatment
From where data/document is obtainable
Abolghasem Mirzaei Kermanshah University of Medical Sciences
What processes are involved for a request to access data/document