Assessment of topical Palm date (Phoenix dactylifera L.) product on clinical manifestation of knee Osteoarthritis versus Diclofenac gel: A randomized clinical trial
Determination of effect of topical palm date product on clinical manifestation of knee Osteoarthritis versus Diclofenac gel
Design
Randomized controled clinical trial with a parallel group design of 94 patient
Settings and conduct
Study will perform in Tabriz Shohada hospital.Participants after informed consent obtaining, will be placed on case and control groups according block disign randomization method and receive their drugs for one month and thay are under observe thru this month
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 40 to 70 ; Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale ; Minimum annoying pain in last (at least ) 4 week before randomized selection according to VAS scale ; Pain at least in one knee in last 3 month ago.
Exclusion criteria: Allergy to palm date product or Diclofenac jel ; Skin lesion on knee ; Scondary osteoarthritis ; Joint transplantation ; Oral or topical use of steroids ; Pregnancy & lactation ; Addiction ; Radiculopathy or Neuropathy ; Surgery ; Trauma
Intervention groups
The case group will receive topical palm date product for topical knee use and Control group will receive diclofenac jel for topical knee use.
Main outcome variables
1. Knee pain score according to Visual Analogue Scale and West Ontario McMaster universities questionaire
2. Knee stiffness score according to West Ontario Mc master universities questionaire
3. Daily activity score according to Visual Analogue Scale and West Ontario Mc master universities questionaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180126038510N1
Registration date:2018-08-25, 1397/06/03
Registration timing:prospective
Last update:2018-08-25, 1397/06/03
Update count:0
Registration date
2018-08-25, 1397/06/03
Registrant information
Name
Alireza Bagherzadehkarimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3668 3374
Email address
bagerzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of topical Palm date (Phoenix dactylifera L.) product on clinical manifestation of knee Osteoarthritis versus Diclofenac gel: A randomized clinical trial
Public title
Assessment of Palm date (Phoenix dactylifera L.) on clinical manifestation of knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale
Pain at least in one knee in last 3 month ago
Minimum annoying pain in last (at least ) 4 week before randomized selection according to VAS scale
Exclusion criteria:
Allergy to topical preparation of Date palm and Diclofenac gel
Skin lesion on the knee
Secondary Osteoarthritis as Rhuomatoid arthritis,Gout,Infectious arthritis,Metabolic arthritis,Traumatic arthritis
Operative knee joint replacement
Topical or systemic steroid use since 14 day before study
Intraarticular steroid injection since 90 day before study
Pregnancy and lactation period
Alcohol and opioid addiction
Radiculopathy and Neuropathy
History of any kind of knee operation and trauma
Utilization of other analgesic drugs since study period
Nonconformity of life style according to knee health
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Block design randomization as individual by Random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences central building , Daneshgah Ave. , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.TBZMED.REC.1397.227
Health conditions studied
1
Description of health condition studied
Osteoarthritis of Knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Score of knee pain intensity
Timepoint
Measuring the Score of knee pain intensity at the beginning of the study and 14 and 28 days after starting use of Palm date ointment.
Method of measurement
Visual Analogue Scale And Western Ontario and McMaster Universities Osteoarthritis questionnaire
2
Description
Score of knee stiffness intensity
Timepoint
Measuring Score of knee stiffness intensity at the beginning of the study and 14 and 28 days after starting use of Palm date ointment.
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis questionnaire
Secondary outcomes
1
Description
Daily activity Score
Timepoint
Measuring of Daily activity Score at the beginning of the study and 14 and 28 days after starting use of Palm date ointment.
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis questionnaire
Intervention groups
1
Description
Intervention group: This group will expose Topical Palm date Preparation to their involved knees three times a day at a rate of one index of the index finger for 4 weeks.Preparation will prepare at the pharmacy lab at the Faculty of Traditional Medicine of Tehran University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: This group will expose Diclofenac jel to their involved knees three times a day at a rate of one index of the index finger for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Alireza Bagherzadehkarimi
Street address
Shohada hospital , Golshahr St., El-goli Ave.
City
ٰTabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3389 3336
Email
maralan-bagherzadeh@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golghasht Ave., No 2 Central Building of tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 9798
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Bagherzadehkarimi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3668 3374
Fax
Email
Bagerzadeha@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Bagherzadehkarimi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3668 3374
Fax
Email
Bagerzadeha@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Bagherzadehkarimi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3668 3374
Fax
Email
Bagerzadeha@tbzmed.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