The Effect of a formulation containing Boswellia Serrata extract on the Osteoarthritis patients’ pain alleviation and quality of life improvement and comparison with Placebo and Piroxicam Gel
Evaluation of the effect of Boswellia Serrata extract on OA Patients' Quality of Life Improvement
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
A double blind study on the effects of Boswellia Serrata extract on Osteoarthritis patient's QOL that will .take place in Golestan Hospital,Ahvaz, Khouzestan, Iran. Patients, and the researchers are blinded
Participants/Inclusion and exclusion criteria
Patient's presenting with knee pain with Osteoarthritis as a diagnosis;
at least three months since diagnosis;
Visual Analog Scale score must be more than 40 after stopping the treatment for 7 days;
Lequesne functional Index more than 7 after stopping the treatment for 7 days;
Patients must have the ability to stand and walk and to provide written and oral consent;
Intervention groups
An intervention group using an ointment containing Boswellia Serrata Extract for 4 weeks three times a day
A control group using Piroxicam ointment for 4 weeks three times a day
A control group using Placebo ointment for 4 weeks three times a day
Main outcome variables
Stiffness of the Joint;
Joint function;
Pain;
Quality of life;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042264N1
Registration date:2019-03-05, 1397/12/14
Registration timing:registered_while_recruiting
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Ehsan Hedayatinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 3368
Email address
hedayatee.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a formulation containing Boswellia Serrata extract on the Osteoarthritis patients’ pain alleviation and quality of life improvement and comparison with Placebo and Piroxicam Gel
Public title
The Effect of Boswellia Serrata Extract on Osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's presenting with knee pain with Osteoarthritis as a diagnosis
at least three months since diagnosis
Visual Analog Scale score must be more than 40 after stopping the treatment for 7 days
Lequesne functional Index more than 7 after stopping the treatment for 7 days
Patients must have the ability to stand and walk and to provide written and oral consent
Exclusion criteria:
Allergy of any kind to Boswellia and any of it's derivatives
Malignancy
Patient's unresponsive to conventional treatment
Inflammatory Arthropathies
Hyperuricemia
Surgery planned
New injury in sight of OA
Intraarticular corticosteroid injection in the past 3 months
Liver or Renal Failure
History of gastric ulceration
Uncontrolled Hypertension
Congestive Heart Failure
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using Research Randomizer(freely available at www.randomizer.org) sixty random numbers are generated. this unsorted series of numbers are then used to assign coded drugs to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo produced in the faculty of pharmacy in addition to Piroxicam gel were given to an independent group for packing. all the material is then packed in completely similar tubes, containing a numbered code and instructions on how to use. these tubes are then given to the clinical team for assigning to the patients. The patient, the researcher and the clinical team are kept unaware of the contents of each tube.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.AJUMS.REC.1397.787
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
Stiffness of the Joint
Timepoint
The beginning of the study, 7, 14, 28 days after start of drug use
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index
2
Description
Joint function
Timepoint
The beginning of the study, 7, 14, 28 days after start of drug use
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index; Lequesne Functional Index
3
Description
Pain
Timepoint
The beginning of the study, 7, 14, 28 days after start of drug use
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index; Visual Analog Scale
4
Description
Improvement in Quality of Life
Timepoint
The end of the study
Method of measurement
Summation and Analysis of The Western Ontario and McMaster Universities Osteoarthritis Index and Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal Cream containing Boswellia Serrata Extract, Produced in Ahvaz Jundishapur University of Medical Sciences; 3 times a day for 4 weeks
Category
Rehabilitation
2
Description
Control group: Placebo cream, Produced in Ahvaz Jundishapur University of Medical Sciences, 3 times a day for 4 weeks
Category
Placebo
3
Description
Control group: Piroxicam 0.5% Gel , Produced by Razak Laboratories Co., 3 times a day for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Teaching Hospital
Full name of responsible person
Karim Mowla
Street address
Golestan Teaching Hospital - Farvardin St - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
mowla-k@ajums.ac.ir
Web page address
http://hgolestan.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Mowla
Street address
Golestan Teaching Hospital - Farvardin St - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
mowla-k@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Mowla
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Teaching Hospital - Farvardin St - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
mowla-k@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Mowla
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Teaching Hospital - Farvardin St - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
mowla-k@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Hedayatinejad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of medicine - Ahwaz Jundishapur University of Medical Sciences - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3334 3368
Fax
Email
Hedayatee.e@ajums.ac.ir
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
Only a part of data will be published
When the data will become available and for how long
The data will be accessible until 6 months after the publication of the results
To whom data/document is available
The data will be available to researchers and scientists working in registered academic and scientific institutions
Under which criteria data/document could be used
The obtained data will be available for further analysis
From where data/document is obtainable
All interested parties should contact the corresponding author by e-mail
What processes are involved for a request to access data/document
after contacting the corresponding author, the data will be sent to Golestan hospital security for publication clearance, after the clearance, the data will be sent to the applicant