Effects of topical tumeric (Domestica Val. Curcuma) and Serrapeptase on reducing pain and improve range of motion in patients with osteoarthritis of the knee ( a double blind randomized controlled trial)
Determining the effect of topical turmeric (Domestica Val. Curcuma) and Serrapeptase in reducing painو improving range of motion and reducing joint stifness in patients with knee osteoarthritis compared to controls
Design
80 participants (no=40 per group) are randomly assigned to intervention and placebo group using random digit table, trial phase 3
Settings and conduct
This double blinded study will be performed in Fayazbakhsh hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age>45y and having knee osteoarthritis according to American College of Rheumatology diagnostic criteria
Knee pain with at least three of the followings: age>50, morning stiffness<30 min, crepitation, bone tenderness at knee, knee bone enlargement, warmness or pain in addition to osteophyte according to radiography
Grade 2 or 3 of osteoarthritis according to Kellgren and Lawrence system
Pain intensity between 5-8 at baseline according to VAS
Able to walk independently
Exclusion criteria: not having joint arteritis, orthopedic or severe cardiovascular diseases
intra-articular injection of corticosteroids in past 3 months, as well as gel, and PRP in past year
Severe pain or allergic reaction during intervention that need for NSAIDs
unable to complete the study
BMI>35
Intervention groups
After determining pain intensity using VAS and range of motion and stiffness using WOMAC, patients will receive topical serapeptase and turmeric or placebo every 4h for 10 days. Each. VAS and WOMAC will check again after 10 days
Main outcome variables
Main output: effect of turmeric/serapeltase on pain, range of motion and stiffness of patients with knee osteoarthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140804018677N7
Registration date:2021-02-26, 1399/12/08
Registration timing:prospective
Last update:2021-02-26, 1399/12/08
Update count:0
Registration date
2021-02-26, 1399/12/08
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of topical tumeric (Domestica Val. Curcuma) and Serrapeptase on reducing pain and improve range of motion in patients with osteoarthritis of the knee ( a double blind randomized controlled trial)
Public title
Effects of tumeric and Serrapeptase gel on reducing pain and improve range of motion in patients with osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age>45y and having knee osteoarthritis according to American College of Rheumatology diagnostic criteria
Knee pain with at least three of the followings: age>50, morning stiffness<30 min, crepitation, bone tenderness at knee, knee bone enlargement, warmness or pain in addition to osteophyte according to radiography
Grade 2 or 3 of osteoarthritis according to Kellgren and Lawrence system
Pain intensity between 5-8 at baseline according to VAS
Able to walk independently
Exclusion criteria:
having joint arteritis, orthopedic or severe cardiovascular diseases
having intra-articular injection of corticosteroids in past 3 months, as well as gel, and Platelet-rich plasma (PRP) in past year
having allergic reaction to tumeric and Serrapeptase
Age
From 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code at the time of sampling
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1030
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Baseline and at the end of the study
Method of measurement
VAS (visual analog scale)
2
Description
Range of Motion and stiffness
Timepoint
Baseline and at the end of the study
Method of measurement
WOMAC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be asked to gently rub a thin layer of gel containing 0.3% serapeptase and 0.3% bromolin every 4 hours for 10 days.
Category
Treatment - Other
2
Description
Control group: Patients will be asked to gently rub a thin layer of gel containing Triethanolamine every 4 hours for 10 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayaz Bakhsh Hospital
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619537
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619537
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619537
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
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
All data would be available to public
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
To all
Under which criteria data/document could be used
No other criteria
From where data/document is obtainable
Email to soodehrazeghi@gmail.com
What processes are involved for a request to access data/document