Comparison of Nigella sativa and diclofenac gel on knee pain reduction due to osteoarthritis
Design
Two arm parallel group randomised trial with blinded postoperative outcome assessment will be performed on 70 patients during one year
Settings and conduct
This study will be performed on patients with knee osteoarthritis referred to the Ali ibn Abi Talib hospital in Zahedan for a period of one year. Patients are randomly divided into two groups receiving nigella sativa oil and diclofenac gel, and prescribed drugs will administrated for patients. Patients, data collectors and analyzer will not be aware of the drugs received
Participants/Inclusion and exclusion criteria
Including criteria consists of patients with knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology (ACR = 2_3); satisfaction to enter the study, and non-entry conditions include joint edema; joint inflammation; liver and kidney failure; and the use of neurological drugs.
Intervention groups
The intervention group rub one gram of nigella sativa oil on a knee every six hours for three weeks, and the control group rub one gram diclofenac gel on a knee every six hours for three weeks and knee pain will measured before and one hour after taking the drug.
Main outcome variables
Pain based on the Visual Analogue Scale (VAS); The intensity of osteoarthritis based on the KellgreneLawrence scale; Patients knee conditions based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181211041923N1
Registration date:2019-07-14, 1398/04/23
Registration timing:retrospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Marzieh Amirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5738
Email address
marzieh.amirian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Nigella sativa oil and Dichlophenac Gel on the reduction of knee pain in patient with Osteoarthritis
Public title
The effect of Nigella sativa oil and Dichlophenac Gel on the reduction of knee Osteoarthritis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiant with knee osteoarthritis based on ACR=2_3 and clinical standard
Satisfaction to enter the study
Exclusion criteria:
Joint effusion
Arthritis
Liver and kidney failure
Consumption of neurological drugs
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not be aware of the type of medication they receive and the second executor of the research project will complete the questionnaire at the end of the treatment without knowledge of the two groups. Also the data will be analyzed without any information about group selection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Research Deputy, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2018-07-27, 1397/05/05
Ethics committee reference number
IR.ZAUMS.REC.1397.127
Health conditions studied
1
Description of health condition studied
Patients with knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology (ACR = 2_3)
ICD-10 code
80-M94
ICD-10 code description
Osteopathies and chondropathies
Primary outcomes
1
Description
Pain based on the Visual Analogue Scale (VAS)
Timepoint
At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The intensity of osteoarthritis based on the KellgreneLawrence scale
Timepoint
At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration
Method of measurement
KellgreneLawrence scale
2
Description
Patients knee conditions based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint
At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Intervention groups
1
Description
Intervention group: rub one gram of nigella sativa oil on a knee every six hours for three weeks
Category
Treatment - Drugs
2
Description
Control group: rub one gram diclofenac gel on a knee every six hours for three weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib hospital
Full name of responsible person
Mahnaz Sandooghi
Street address
Ali ibn Abi Talib hospital, Salamat Blvd, Persian Gulf Expressway
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Mahnazsandooghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Research Deputy, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Sandooghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5796
Email
Mahnazsandooghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Sandooghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5796
Email
Mahnazsandooghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Sandooghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5796
Email
Mahnazsandooghi@yahoo.com
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