Evaluation of the Anti inflammatory effects of curcumin and bromelain supplements on patients with knee osteoarthritis
Design
This study is a phase 2-3 clinical trial in the form of a single blinded study with three parallel groups randomly (block randomization).
Settings and conduct
This study is being conducted single blind in a specialist office located in Nazi Abad, Tehran .In this study, participants will not know which group they are in.
Participants/Inclusion and exclusion criteria
All adult patients (over 18 years) with osteoarthritis who are not allergic to pineapple, celery, carrots, and fennel will participate in the study. Patients with hemophilia, those taking two antiplatelet drugs, those suspected of having an infection, with severe renal and liver failure, and pregnant or breastfeeding women will not be included in the study.
Intervention groups
The first group will receive 200 mg of Celecoxib once daily, The second group, will receive 200 mg of Celecoxib twice daily. The third group, will take a curcumin and bromelain supplement twice daily along with 200 mg of Celecoxib once daily
Main outcome variables
Comparison of pain and inflammation in patients based on WOMAC scale and Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058615N4
Registration date:2024-09-07, 1403/06/17
Registration timing:prospective
Last update:2024-09-07, 1403/06/17
Update count:0
Registration date
2024-09-07, 1403/06/17
Registrant information
Name
Amir Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 729 8761
Email address
rezazadeh.am@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of bromelain and curcumin supplement in osteoarthritis outpatients, Randomized clinical trial
Public title
Effect of bromelain and curcumin supplement in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years old and suffer from non-infectious knee osteoarthritis
Exclusion criteria:
Sensitivity to pineapple ,celery, carrot and fennel
Haemophilia
Who take two antiplatelet drugs or one antiplatelet drug and one anticoagulant drug
Suspicion of infection
severe kidney impairment ( GFR< 30)
severe liver impairment (child Pugh C and B )
Pregnant and breastfeeding women
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, volunteers were individually assigned to Three groups using block randomization. It should be noted that 6 sized blocks are used in this method.
Block randomization was done using the "https://www.sealedenvelope.com/simple-randomiser/v1/lists" website and the obtained specialized codes (including two English letters and one number) were assigned to each candidate in the order of entry.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single-blind, where the participants will not be informed, and only the doctor and the university researcher responsible for monitoring the patient will be aware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran,1449614535,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.IUMS.REC.1402.1029
Health conditions studied
1
Description of health condition studied
Effect of bromelain and curcumin supplement in knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
Reduction of knee inflammation
Timepoint
The first week, the end of the second week, and the end of the month
Method of measurement
Measurement by WOMAC scale and Visual Analogue Scale
Secondary outcomes
1
Description
Examination of the inflammatory process and pain level
Timepoint
Week one, end of week 2 , and end of the month
Method of measurement
Evaluation of factors in the knee functional questionnaire and visual analogue scale
Intervention groups
1
Description
Intervention group 1: The first group, consisting of 20 patients, will receive 200 mg of Celecoxib once daily for one month.
Category
Treatment - Drugs
2
Description
Intervention group 2:The second group, also consisting of 20 patients, will receive 200 mg of Celecoxib twice daily for one month.
Category
Treatment - Drugs
3
Description
Intervention group 3:The third group, consisting of 20 patients, will take a curcumin and bromelain supplement manufactured by Salamat Parmoon Amin twice daily along with 200 mg of Celecoxib once daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private doctor office
Full name of responsible person
Behzad.khanmohammadi
Street address
No. 8, 3rd Floor, Khozai Pour Alley, Madayin Street, Nazi Abad.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 938 660 7551
Email
Behzad.khanmohamadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 7086 3020
Email
pooyanorozi75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Assistant Professor of Pharmacotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Iran university of medical sciences, shahid Basarti St, Shahid Kabiri Tameh Street ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1475886671
Phone
+98 21 6044 8161
Email
pooyanorozi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1475886671
Phone
+98 912 729 8761
Email
rezazadeh.am@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1475886671
Phone
+98 912 729 8761
Email
rezazadeh.am@iums.ac.ir
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 final results of scoring the inflammation status, pain, and related parameters
When the data will become available and for how long
After publishing the related article in international journals
To whom data/document is available
Researchers in the field of medicine and pharmacy
Under which criteria data/document could be used
Development of science and expand evidence related to treatment in further research
From where data/document is obtainable
Related journal
What processes are involved for a request to access data/document
Using the journal email to communicate and register a request to use the study data