Determining and comparing the effect of topical application of Alpinia galanga oil with Diclofenac topical gel on joint pain due to knee osteoarthritis
Design
Randomized clinical trial with control group, with parallel groups, triple blind, randomized on 158 patients. Random sequences will be performed as quadruple blocks using statistical software.
Settings and conduct
The place of the study will be health centers is Sabzevar. The study will be double blind in which drug packages are quite similar in shape and the patient and the executor of the design and analyzer are not aware of the contents of the packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 45 to 70 years; Patients with osteoarthritis; Written consent to participate in the study; Possibility of taking medicines on time.
Non-Inclusion criteria: Patients with abnormal knee anatomy; joint replacement surgery; knee joint infections; serious underlying diseases; severe skin problems of the knee area; intra-articular injection of steroids within the last three months; intramuscular injection of steroids within the last month; known intolerance or allergy to diclofenac or Alpinia galanga oil.
Intervention groups
Intervention group: 5 to 10 drops of Alpinia galanga oil (made by Tehran School of Pharmacy), twice a day for 28 days, topically on the painful joint.
Control group: diclofenac gel (product of Behozan Pharmaceutical Company), twice a day for 28 days, topically on the painful joint.
Main outcome variables
Pain; joint function; joint stiffness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200701047978N1
Registration date:2020-08-16, 1399/05/26
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Samaneh Sadat Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4424 3658
Email address
samanesadatasadi1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-04, 1399/05/14
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical application of Alpinia galanga (Qost) Oil and Diclofenac jel on symptoms of knee osteoarthritis
Public title
The effect of Alpinia galanga oil on reducing the symptoms of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45 to 70 years old
Patients with osteoarthritis according to the American College of Rheumatology Criteria and grade 1 to 3 osteoarthritis according to the Clagren-Lawrence criterion
Written consent to enter the study
Patient cooperation during the study
Possibility of timely and correct use of medicine
Exclusion criteria:
Patients with abnormal knee anatomy and joint replacement surgery
Patients with knee joint infections
Suffering from serious underlying diseases such as liver and kidney disorders, diabetes, etc.
Patients with severe skin problems of the knee area
Patients with intra-articular injection of steroids within the last three months prior to enrollment
Patients with intramuscular steroid injections within the past month before enrollment
Patients with known intolerance or allergy to Diclofenac or Alpinia Galanga
Blindness and deafness or inability to communicate
Taking psychotropic drugs
Taking drugs or taking corticosteroids
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
A simple, block randomization method will be used for randomization. The individual randomization unit and the randomization tool are sealed drug packages that are completely similar in shape and the patient and the project operator are not aware of the contents of the packages. The allocation of samples in the study will be based on a random sequence provided by the statistical consultant using statistical software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Both painkillers are placed in boxes A (Alpinia Galanga) and B (Diclofenac Jel). Samples are treated with medication packages pre-determined by the study supervisor (supervisor). The drug packages are quite similar in shape and the patient and the executor of the plan are not aware of the contents of the packages. In addition, collecting information, assessing patients and completing forms is done by the project manager and his assistant who are not aware of the contents of the packages. Data analysis is also done by the statistician of the project consultant and the project manager who are not aware of the contents of the drug packages.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Headquarters of Sabzevar University of Medical Sciences; Asadabadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.MEDSAB.REC.1398.124
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel
Method of measurement
WOMAC standard questionnaire
2
Description
Physical function
Timepoint
Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel
Method of measurement
WOMAC standard questionnaire
3
Description
Joint dryness
Timepoint
Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel
Method of measurement
WOMAC standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Alpinia galanga Oil 5 to 10 drops (amount of active ingredient equal to 80% in sesame oil base made by Tehran School of Pharmacy), twice a day for 28 days topically on the painful joint
Category
Treatment - Drugs
2
Description
Control group: Diclofenac gel (topical gel 1% 60 g product of Behozan Pharmaceutical Company) twice a day for 28 days topically on the painful joint
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar health centers
Full name of responsible person
Fereshteh Ghorat
Street address
Headquarters of Sabzevar University of Medical Sciences; Asadabadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 1000
Fax
+98 51 4401 8484
Email
info@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Headquarters of Sabzevar University of Medical Sciences; Asadabadi street
City
Sabzavar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 1000
Fax
+98 51 4401 8484
Email
info@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Headquarters of Sabzevar University of Medical Sciences; Asadabadi street
City
Sabzavar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 1000
Fax
+98 51 4401 8484
Email
drghorat@gmail.com
Web page address
http://www.medsab.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Asadabadi St., Central Organization of University of Medical Sciences., Sabzevar Town
City
Sabzavar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 1000
Fax
+98 51 4401 8484
Email
drghorat@gmail.com
Web page address
http://www.medsab.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samaneh Sadat Asadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Memarzadeh closed end alley; Enghelab 5 avenue; Najarabad blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4424 3658
Fax
Email
samanesadatasadi1992@gmail.com
Web page address
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