The aim of this study is to compare the effect of topical application of diclofenac Black cumin (Nigella sativa) oil on knee joint pain of elderly. The population of this study was consisted of women and men aged 60 to 80 years old who referred to traditional medicine Salamatkadeh (traditional medicine Health compartment) affiliated by Sabzevar University of Medical Sciences. Sample size: 52 patients with knee joint pain. The study was a double-blind clinical trial with Intervention (black cumin oil) and Control (diclofenac gel) groups. The subjects were not aware of the choice of the type of the study group. Easy sampling was performed and then random allocation was done by permutation blocking method. Topical application of drugs was performed twice a day for 21 days. Inclusion criteria: being at the age of 60 to 80 years old; diagnosis of knee Osteoarthritis according to American College Rheumatologic Diagnostic Criteria; Crepitus; morning knee stiffness less than 30 minutes; and inflammation in the knee examination, Exclusion criteria: cancer; Addiction; treatment with corticosteroids and glucosamine; blindness and Deafness and lack of communication. Primary outcome variable: knee pain; pain intensity; pain quality; pain time; joint stiffness; daily activities; recreational activities. Secondary outcome variable: adverse drug reaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080835563N1
Registration date:2017-10-27, 1396/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Fatemeh Azizi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 0846
Email address
azizif1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical application of black cumin oil and diclofenac sodium topical gel on elderly knee pain
Public title
The effect of black cumin oil on Knee joints pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being at the age of 60 to 80 years old; diagnosis of knee Osteoarthritis according to American College Rheumatologic Diagnostic Criteria; Crepitus; morning knee stiffness less than 30 minutes; ; Knee osteoarthritis was confirmed by a physician and radiographic evidence; inflammation in the knee examination. Exclusion criteria: blindness and Deafness and lack of communication; cancer; Addiction; treatment with corticosteroids and glucosamine.
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation was done by permutation blocking method.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.MEDSAB.REC.1396.47
Health conditions studied
1
Description of health condition studied
knee joint pain
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
Knee joint pain
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
2
Description
Intensity of pain
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
3
Description
Pain quality
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
4
Description
Pain time
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
5
Description
Joint stiffness
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
6
Description
daily activities
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
7
Description
Recreational activities
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
8
Description
Quality of Life
Timepoint
Before the study - 10 days after the study - 21st day and the end of the study
Method of measurement
knee injery and osteoarthritis outcom score(koos)
Secondary outcomes
1
Description
Advers drug reaction
Timepoint
Every week after the beginning of the study, one week after the end of the study
Method of measurement
Patient's report
Intervention groups
1
Description
Control group: topical application of diclofenac sodium gel 1% (2 g in the morning and at night for 21 days, produced by Tehran Razak Company.
Category
Treatment - Drugs
2
Description
Intervention group: Local application of black cumin oil (1 cc in the morning and night) for 21 days from the Isfahan Ganjineh osare Tabiat pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Health Center, Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Azizi Nursing Graduate Student
Street address
Health Center of Sabzevar University of Medical Sciences,Asad Abadi Street
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard
City
Sbzevar
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 Sabzevar University of Medical Sciences
Proportion provided by this source
100
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
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Azizi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4464 0846
Fax
Email
azizi.azar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mustafa Rad
Position
Ph.D. Nursing
Other areas of specialty/work
Street address
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard
City
Sabzevar
Postal code
9613873136
Phone
+98 514446070
Fax
Email
mostafarad633@ yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Azizi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Nursing Graduate Student
City
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard
Postal code
9613873136
Phone
+98 51 4464 0846
Fax
Email
azizi.azar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)