Evaluation of the effect of Elaeagnus angustifolia alone and in combination with Boswellia thurifera compared with ibuprofen in patients with knee osteoarthritis
Objectives:
1. Determination and comparison of pain severity in patients with knee osteoarthritis before and after the interventions
2. Determination and comparison of function in patients with knee osteoarthritis before and after the interventions
Design:
- study groups: patients with knee osteoarthritis referring to Rheumatology clinic of Al-Zahra hospital of Isfahan
- Groups and sample size: three 25-patient groups
- Blinding: double-blind
- Randomization: simple
- Setting and conduction: for the three groups, the capsules of Elaeagnus angustifolia extract, Elaeagnus angustifolia/Boswellia thurifera extracts, and ibuprofen will be administered, respectivley. The values of variables before and after the intervention will be compared between the groups.
Participants:
1. age of 40 to 80 years
2. having osteoarthritis of at least one knee for at least 6 months
3. no liver or renal dysfunction
4. no injection of intra-articular glucocorticoids within the past 3 months
Intervention:
- group 1: the capsule of Elaeagnus angustifolia extract (200 mg) three times daily
- group 2: the capsule of Elaeagnus angustifolia/Boswellia thurifera extracts (200/100 mg) three times daily
- group 3: the capsule of ibuprofen (400 mg) three times daily
- duration: 4 weeks
Main outcome measures:
- the pain score using visual analogue scale (VAS)
- the score of Lequesne's pain and function index (LPFI)
- the score of global patients assessment (PGA)
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015072123282N1
Registration date:2015-09-09, 1394/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan Barij Essence Pharmaceutical Company and Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Elaeagnus angustifolia alone and in combination with Boswellia thurifera compared with ibuprofen in patients with knee osteoarthritis
Public title
Evaluation of the effect of Elaeagnus angustifolia alone and in combination with Boswellia thurifera compared with ibuprofen in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 40 - 80 years; Osteoarthritis of at least one knee for at least 6 months based on the diagnostic criteria of American College of Rheumatology (ACR); Pain score > 40 mm based on the visual analogue scale (VAS); CRP serum level < 10 mg/dL; LPFI (Lequesne Pain and Function Index) score > 7; Grade 2 or 3 of Kellgren-Laurence scale in knee radiography within the past 6 months
Exclusion criteria: Dysfunction of either liver, kidneys, or cardiovascular system or malignancy; 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 3 months; Having other osteoarticular disorders (e.g., rheumatoid arthritis and gout); Uncontrolled hypertension (> 140/90 mm Hg); Increased ESR; Having gastric or duodenal ulcers (based on the medical history); Sensitivity to the intervention drug; Being candidate for arthroplasty surgery; Not use of the intervention drug for more than one week; Knee arthroscopy within the past 3 months; Illiteracy
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using random number table.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar-Jerib Avenue, Vice-chancellery for research, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2014-10-26, 1393/08/04
Ethics committee reference number
393538
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
Lequesne's Pain and Function Index (LPFI)
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
1
Description
adverse effects
Timepoint
during the intervention
Method of measurement
patient report
Intervention groups
1
Description
Intervention group 1: Elaeagnus angustifolia extract, capsule 200 mg (Barij Essence, Kashan), three times daily for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Elaeagnus angustifolia extract/Boswellia thurifera extract, capsule 200 mg/100 mg (Barij Essence, Kashan), three times daily for 4 weeks
Category
Treatment - Drugs
3
Description
Control group: Ibuprofen, capsule 400 mg (Barij Essence, Kashan), three 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
Soffeh Avenue, Al-Zahra Educational and Therapeutic Center
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical Company
Full name of responsible person
Valiollah Hajhashemi
Street address
Mashhad Ardehal
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice-Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezar-Jerib Avenue, Isfahan University of Medical Sciences
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Ph.D/Scientific member of university
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7067
Fax
Email
soltani@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Ph.D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7067
Fax
Email
soltani@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Ph.D / Faculty Member
Other areas of specialty/work
Street address
Hezar-Jerib Avenue, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)