Evaluation of the effectiveness of frankincense oily lotion containing boswellic acid enriched extract in the treatment of knee osteoarthritis symptoms: a randomized placebo-controlled clinical trial
Evaluation of the effectiveness of frankincense extract in the treatment of knee osteoarthritis
Design
Two arm parallel group randomized placebo-controlled clinical trial, phase 3 on 50 patients. Block randomization method with blocks of 4 will be used for randomization.
Settings and conduct
The study will be performed at the rheumatology clinic of Al-Zahra hospital of Isfahan.The subjects in the experimental and control groups will be instructed to use Boswellia and placebo topical lotions, respectively, 3 times daily for 4 weeks on the knee. The scores of WOMAC osteoarthritis index, visual analogue ascale, and patient global assessment will be determined and recorded before and at the end of intervention and compared between the two groups.
Participants/Inclusion and exclusion criteria
1. Age of 40 - 80 years
2. Osteoarthritis of at least one knee for at least 3 months based on the diagnostic criteria of American College of Rheumatology (ACR)
3. Pain score > 4 based on the visual analogue scale (1 to 10)
4. Grade 2 or 3 of Kellgren-Laurence scale in the knee radiography performed within the past 3 months
Intervention groups
Experimental group: frankincense extract lotion (manufactured by Fardis pharmaceutical company) containing 65% boswellic acid, topical application, 3 times daily, for 4 weeks
Control group: placebo lotion (manufactured by Fardis pharmaceutical company), topical application, 3 times daily for 4 weeks
Evaluation of the effectiveness of frankincense oily lotion containing boswellic acid enriched extract in the treatment of knee osteoarthritis symptoms: a randomized placebo-controlled clinical trial
Public title
Effect of Boswellia in treatment of knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of 40 - 80 years
Osteoarthritis of at least one knee for at least 3 months based on the diagnostic criteria of American College of Rheumatology (ACR)
Pain score > 4 mm based on the Visual Analogue Scale (VAS)
Grade 2 or 3 of Kellgren-Lawrence scale in knee radiography within the past 3 months
Exclusion criteria:
Use of intra-articular glucocorticoids within the past 3 months
Use of intra-articular sodium hyaluronate within the past 6 months
Use of systemic glucocorticoids (either oral or parenteral) within the past 14 days
Having other osteoarticular disorders (e.g., rheumatoid arthritis and gout)
Skin disorder in knee region
Sensitivity to prescribed topical formulations
Knee arthroscopy within the past 3 months
Illiteracy
Unable to answer the questions
Pregnancy
Lactation
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study Block Randomization will be used. For this purpose, quadruple blocks will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo lotions will be packaged in completely similar containers and the prescribing physician, data collecting person and patient will be blinded to the content of containers.
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-07-15, 1399/04/25
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.233
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
Other prim
ICD-10 code description
M17.1
Primary outcomes
1
Description
WOMAC Index
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Questionnaire
2
Description
visual analogue scale (VAS)
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
scoring on the scale
3
Description
patient global assessment (PGA)
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
scoring on the scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oily lotion of frankincense extract containing 65% boswellic acid (manufactured by Fardis pharmaceutical company), 3 times daily for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo lotion (manufactured by Fardis pharmaceutical company), 3 times daily for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic of Al-Zahra hospital
Full name of responsible person
Rasool Soltani
Street address
Al-Zahra Educational and Therapeutic Center, Soffeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3303 3950
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fardis pharmaceutical company
Full name of responsible person
Valiollah Hajhashemi
Street address
Science and technology of health park of Isfahan university of medical sciences, Valiye-Asr Ave., Kilometer 10 of Isfahan-Shiraz freeway
City
Isfahan
Province
Isfehan
Postal code
8179154417
Phone
+98 31 3792 3087
Email
farazdaru@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fardis pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Assiciate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.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