Surveying the analgesic effect of topical curcumin in patients with osteoarthritis
Design
Patients were randomly assigned to two groups of 30. A group of patients received 10% curcumin ointment for 2 weeks, and the second group was given a diclofenac gel for 1 week at a dose of 4 times a day for 2 weeks.
Settings and conduct
Patients Dr. Zahra Basiri at the office
Participants/Inclusion and exclusion criteria
1. The person should have mild to moderate knee osteoarthritis.
2. The person should have moderate to severe pain.
And individuals with osteoarthritis associated with joint inflammation are excluded from the study
Intervention groups
Intervention group: Patients with curcumin receiving osteoarthritis
Control group: Patients with diclofenac receiving osteoarthritis
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150628022956N6
Registration date:2018-08-08, 1397/05/17
Registration timing:registered_while_recruiting
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Sara Ataei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 440 2319
Email address
s.ataei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation analgesic effect of curcumin topical formulation in osteoarthritis patients
Public title
effect of curcumin in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The person should have mild to moderate knee osteoarthritis
The person should have moderate to severe pain
Exclusion criteria:
People with osteoarthritis associated with joint inflammation
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
A sample of curcumin and diclofenac ointment is packed in similar packaging and pass code. The researcher and the patient and the data collectors and those who evaluate the outcome do not know the contents of the pack and randomly give a patient an example.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Hamadan University of Medical Sciences
Street address
Hamadan- Pazhoohesh Crossroad-In front of the luna park-Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6581773946
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR.UMSHA.REC.1396.813
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyosteoarthritis, unspecified
Primary outcomes
1
Description
The amount of pain
Timepoint
10 day
Method of measurement
VAS index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with osteoarthritis receiving curcumin 10% for 10 days, 3 times daily for topical use.
Category
Treatment - Drugs
2
Description
Control group: Patients with osteoarthritis receiving diclofenac 10% ointment for 10 days, 3 times daily for topical use.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan
Full name of responsible person
Dr. Zahra Basiri
Street address
میدان قائم بیمارستان شهید بهشتی Ghaem Square, Shahid Beheshti Hospital
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3838 1953
Email
z.azadbakht73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Bashirian
Street address
Hamedan Boulevard, Shahid Fahmidah, facing Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3838 1953
Email
z.azadbakht73@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Sara Ataei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan Boulevard, Shahid Fahmidah, Facing the People's Park of Hamedan University of Medical Sciences, Faculty of Pharmacy
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3838 1953
Email
s.ataei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ِDr. Sara Ataei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
In front of luna park, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 912 440 2319
Fax
Email
S.ataei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Azadbakht
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
In front of Luna park, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 937 111 9886
Fax
Email
z.azadbakht73@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
1398
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Use data with source
From where data/document is obtainable
z.azadbakht73@gmail.com
What processes are involved for a request to access data/document