Comparison of the effect of ginger skin patch and oral capsule on pain severity, stiffness and daily functioning in patients with osteoarthritis of the knee
This research is an interventional study to compare the effectiveness of ginger in two ways: skin patch and oral capsules on pain severity, stiffness and daily functioning in patients with osteoarthritis of the knee. the study population consisted of 120 patients who were divided into 3 groups. Each group consisting of 40 people. Each group receives standard treatment for osteoarthritisٍ. In addition to, the first group will receive a daily ginger skin patch for 13 weeks. The second group will receive two capsules daily. The third group is the control group. Inclusion criteria: confirmed osteoarthritis of the knee by orthopedic specialist; 50 years and older. Exclusion criteria: Not consent to continue study or incidence adverse events in each of the samples. Main outcomes: pain severity, stiffness and daily functioning and secondary outcomes: Dosage analgesic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062722929N1
Registration date:2015-08-25, 1394/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-25, 1394/06/03
Registrant information
Name
Zeinab Alipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 154 3132
Email address
alipour.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University of Medical Sciences
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2015-08-20, 1394/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ginger skin patch and oral capsule on pain severity, stiffness and daily functioning in patients with osteoarthritis of the knee
Public title
Ginger effect on osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: The approval of osteoarthritis of the knee by orthopedic specialist; 50 years and older; Lack of regular use of ginger or sensitivity to it; No injection in the joint or joint surgery for at least 6 months ago; Lack of Rheumatism, Diabetes, Cancer, Alzheimer's and Schizophrenia; No wound in mid-lumbar region. Exclusion criteria: Not consent to continue study; Failure to comply with the study protocol; The incidence of adverse events in each of the samples.
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ahwaz University of Medical Sciences
Street address
Ahwaz University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahwaz
Postal code
61357-15794
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.193
Health conditions studied
1
Description of health condition studied
Osteoarthrities Of Knee
ICD-10 code
M17
ICD-10 code description
Gonarthrosis[arthrosis Of Knee]
Primary outcomes
1
Description
pain severity
Timepoint
Before, during intervention, a week after intervention
Method of measurement
Using a visual scale pain
2
Description
Joint stiffness
Timepoint
Before, during intervention, a week after intervention
Method of measurement
Western Ontario and Mc Master Universities Questionnaire
3
Description
daily performance
Timepoint
Before, during intervention, a week after intervention
Method of measurement
WOMAC Questionnaire
Secondary outcomes
1
Description
Analgesic dose
Timepoint
Before the study, during the study and after study
Method of measurement
Using a questionnaire prepared by the researcher
Intervention groups
1
Description
The first group, will receive a daily skin patch in the mid-lumbar region for 13 weeks, In addition to their standard treatment. This is a skin patch containing one gram of ginger.
Category
Treatment - Drugs
2
Description
The third group is the control group. In this group, only standard medication that is prescribed by orthopedic specialist receive. Intervention is not done.
Category
Treatment - Drugs
3
Description
The second group will receive two capsules daily for 13 weeks, in addition to standard treatment. Each capsule contains 500 mg of ginger.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital Dezful
Full name of responsible person
Dr.nima yegane (orthopedic speciallist)
Street address
Between Beheshti & Ferdowsi street, at the Corner of the Rosta, Afshar Square, Dezful
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Science and Technology University of Medical Sciences and Health Services, Ahvaz
Full name of responsible person
Dr. Nader Saki
Street address
Central Library, University of Medical Sciences Jundishapur, Golestan Blvd., Ahvaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Science and Technology University of Medical Sciences and Health Services, Ahvaz
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
School of Nursing and Midwifery, Ahwaz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Asadizaker
Position
PHD of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahwaz University of Medical Sciences
City
Ahwaz
Postal code
Phone
00
Fax
Email
marziyehasadizaker@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy, Ahwaz University of Medical Sciences,
Full name of responsible person
Dr. Maryam Koochek
Position
PhD Pharmaceuticals
Other areas of specialty/work
Street address
School of Pharmacy, Ahwaz University of Medical Sciences,
City
Ahwaz
Postal code
Phone
00
Fax
Email
KoocheKm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Zeinab Alipour
Position
MSC student of nursing
Other areas of specialty/work
Street address
Setayesh 1, Vakilzadeh, Andimeshk, Khozestan
City
Andimeshk
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)