The effect of Olibanum (Boswellia serrata) gel on clinical symptoms in patients with Osteoarthritis of the knee - a double-blind, placebo-controlled, randomized trials
The aim of this study was to evaluate the effect of Olibanum gel on clinical symptoms in patients with Osteoarthritis of the knee
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 78 patients. Excel was used for randomization.
Settings and conduct
Rheumatology Clinic of Rafsanjan Patients who meet the inclusion criteria is included in the study. Physicians, researchers, and patients are blind. Patients are visited in weeks 0 and 4, and questionnaires and forms are completed for follow-ups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 40 and under 70 years of age meet the ACR (*) clinical and radiological criteria.
Patients with a diagnosis of osteoarthritis grade 1,2,3.
ACR (*):
Knee pain + at least 1 of the following 4 criteria
Morning dryness less than 30 minutes
Crepitus
Osteophyte in radiography
Criteria for not entering: the history of rheumatoid arthritis, gout, CPPD
Existence of uncontrolled cardiovascular disease
The existence of malignancy has been proven.
Severe kidney disease: Creatinine greater than 3 Mg / Dl
Receive oral corticosteroids 4 weeks in advance
Take NSAIDs with a dose of more than 50 mg daily except aspirin and acetaminophen up to a dose of more than 650 mg.
Intra-articular administration of the drug in the previous three months
The patient's unwillingness or ability to fill in the text of the questionnaire used in the study
Exclusion criteria: the patient's unwillingness to continue participating in the study
Out of reach of the patient
Complications during treatment (itching or other complications)
Existence of severe and unbearable pain in the patient
Intervention groups
Intervention group: Olibanum gel ؛ Control group: placebo
Main outcome variables
BMI; KOOS PAIN; KOOS Light daily activity; KOOS Intense and sports activity; Quality of life; acetaminophen per day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201210049670N1
Registration date:2020-12-20, 1399/09/30
Registration timing:prospective
Last update:2020-12-20, 1399/09/30
Update count:0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Roshanak Mokaberinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
mokaberi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Olibanum (Boswellia serrata) gel on clinical symptoms in patients with Osteoarthritis of the knee - a double-blind, placebo-controlled, randomized trials
Public title
The effect of Olibanum (Boswellia serrata) gel on clinical symptoms in patients with Osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients more than 40 and less than 70
Patients with a diagnosis of osteoarthritis grade 1,2,3
knee pain
Morning knee dryness less than 30 minutes
Crepitus
Osteophyte in radiography
Exclusion criteria:
History of rheumatoid arthritis, gout, CPPD
Existence of uncontrolled cardiovascular disease
Proven malignancy
Severe kidney disease (creatinine above 3 Mg /Dl)
Receive oral corticosteroids 4 weeks in advance
Take NSAIDs with a dose of more than 50 mg daily except aspirin and acetaminophen up to a dose of more than 650 mg daily
Intra-articular administration of the drug in the previous three months
The patient's unwillingness or ability to fill in the text of the questionnaire used in the study
The patient's unwillingness to continue participating in the study
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of intervention and control using a simple randomization method prepared by Excel software (table of random numbers). Randomization unit: individual
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be packaged in such a way that the treating physician and patients will not be informed of its contents. (Double blind)
Researchers will also be unaware of the type of ointment 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
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Based on a questionnaire filled out by the patient himself
3
Description
KOOS questionnaire Light daily activity
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Based on a questionnaire filled out by the patient himself
4
Description
KOOS questionnaire Intense and sports activity
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Based on a questionnaire filled out by the patient himself
5
Description
Quality of Life
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Based on a questionnaire filled out by the patient himself
6
Description
Acetaminophen intake per day
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Based on biography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Olibanum (Boswellia serrata) gel gel; Prepared on the basis of 2%Olibanum. To prepare 100 g of gel, 2 g of frankincense is extracted using propylene glycol solvent: water in a ratio of 80 to 20 is extracted by massaging method. The gel is made using the prepared extract, carbomer 940 (1%), soda and distilled water. Physicochemical and microbial quality control tests are performed on the product.
Category
Treatment - Drugs
2
Description
Control group: placebo; Also, using carbomer 940, distilled water and titanium dioxide are prepared as dyes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Abbasifard's Clinic
Full name of responsible person
Mitar Abbasifard
Street address
Modarres Ave, Rafasnjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3523 0475
Email
dr.mabbasifard@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 2660؛ Valiasr St؛ Shahid Beheshti School of Pharmacy؛ Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8. Shams ali,Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
mokaberi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8. Shams ali,Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
mokaberi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8. Shams ali,Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
mokaberi@sbmu.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